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CNS Role Specialty Practicum I: Scholarly Project Paper Translating Evidence into Practice: Therapeutic Hypothermia in Adult Post Cardiac Arrest Patients Roshan Jan Muhammad The Johns Hopkins University School of Nursing “On my honor, I pledge that I have neither given or nor received any unauthorized assistance on this assignment”. RJMAbstractDespite successful cardiopulmonary resuscitation (CPR), the victims of cardiac arrest (CA) have grave prognosis. The most common cause of mortality among post CA patients is anoxic brain injury that accounts for two third deaths in these victims (Stub et al., 2011). This is a consequence of pathological events at cellular level secondary to disrupted calcium homeostasis, free radical formation, and activation of cell-death signaling pathways (Neumar et al., 2008). Therapeutic hypothermia (TH) is recommended as a part of post CA care by International Liaison Committee of Resuscitation (ILCOR) to halt the adverse effects of ischemia on brain; and it is associated with reduced mortality and improved neurological outcome in post CA patients (Nolan et al. (2010)). The purpose of this project was to transform post CA care at the Medical/Surgical Intensive Care Unit (ICU) of the Aga Khan University Hospital (AKUH) by introducing evidence based TH intervention. This pilot project was guided by Complex Adaptive Systems Theory of change. It encompassed need assessment of the institution; multidisciplinary teambuilding; evidenced based protocol development though systematic review; establishment of process monitoring and outcome analysis; resource mobilization; clinical capacity building of the nursing staff; implementation; and execution of measures to ensure sustainability. The success of this pilot project, which is planned for 9 months, would open the avenue of replication to other units like Emergency, Coronary Care Unit and Cardiothoracic Care Unit. Key words: Therapeutic hypothermia (TH),Cardiac arrest (CA), return of spontaneous circulation (ROSC), shockable rhythm (ventricular fibrillation or pulseless ventricular tachycardia), non-shockable rhythm (Asystole or pulseless electrical activity), neurological outcome, mortality, in-hospital, out of hospital cardiac arrest (OHCA) IntroductionCA and related mortality and morbidity are commonly encountered phenomena in a hospital setting. Despite aggressive measures, the outcome post cardiac arrest is still poor, with only 7% to 30% of the patients being discharged from hospital with good neurological outcome (Granja et al., 2011). According to Neumer et al. (2008), CA causes global ischemia, nonetheless, brain is most vulnerable to the adversity of poor perfusion. Neurological damage starts within four to six minutes of CA, if CPR is not initiated. Nevertheless, effective CPR only partially restores perfusion to the vital organs (Cour et al., 2011). While ischemia during CA is damaging to the brain, evidences also suggest that reperfusion post return of spontaneous circulation (ROSC) compliments initial hypoxic insult and perpetuates mitochondrial dysfunction and cellular death (Cour et al., 2011). Consequently, those who survive from CA suffer serious debilitating neurological complications or die due to post cardiac arrest syndrome (Stub et al., 2011). The risk of poor neurological outcome increases with each degree increment in body temperature above 37C post ROSC (Nolan et al., 2010). Mild TH that ranges from 32C to 34C, is known to improve neurological outcome of post CA patients through various neuro-protective effects (Nolan et al., 2010). During the project, I reviewed and synthesized evidences on the role of TH in post CA patients; converged evidences to develop clinical protocol; and initiated pilot project to assess the feasibility of implementing TH for adult post CA patients in the ICU of the AKUH. Assessment of Organizational NeedFor this project the facility of AKUH was selected, which is a tertiary care teaching hospital in Karachi, Pakistan. AKUH is also one of the training centers of the American Heart Association (AHA), which is determined to improve the process and outcome of CA in their facility. According to the CPR committee of the AKUH, total 898 adult patients sustained CA out of 1,37,355 discharges during the period of 2010 to September 2012 at AKUH, with cumulative incidence of 6.53 patients per 1000 discharges. Of 898 patients, only 139 patients survived till the time of the discharge, thus, the overall unadjusted survival to discharge rate is 15.47% in this cohort. Unfortunately, there is no data available on national incidence of CA and related outcome in Pakistan. Therefore, the survival rate of CA at AKUH is compared with the findings reported by the National Registry of Cardiopulmonary Resuscitation of USA. According to the National Registry, the overall rate of survival to discharge was 22.3% and the rate of survival with good neurological outcome was 72% in CA patients during 2009 (Girotra et al., 2012). At the time of assessment, there was no mechanism at AKUH to monitor and follow the cerebral performance of post CA survivors at the time of discharge, thus, the quantum of problem could not be completely gauged. However, comparison of the survival rate revealed that there was an opportunity for AKUH to improve further in this area of health concern. To improve the survival outcome and salvage the neurological state of post CA victims require multi-facet interventions. It include high quality CPR; advanced cardiopulmonary resuscitation (ACLS); optimal support to the vital organs post ROSC; and intervention like therapeutic hypothermia to minimize the neurological sequel (Stub et al., 2011). AKUH has well established policies, procedure and mechanisms to address aforesaid critical needs of post CA patients. All medical staff and paramedics are trained to perform CPR; ACLS trained code team members respond to the code call, routine mock code drills are performed as a quality improvement activities and oversight mechanism is established in form of CPR committee. However, they have not yet adopted the practice of TH. Nonetheless, leadership of the CPR committee and clinical leadership of the ICU were motivated to embark on this initiative. Literature ReviewTH is a tri-phasic intervention which typically include; induction, maintenance and rewarming phase (Stub et al., 2011). According to Beddingfield et al., (2012), TH prevents astroglial proliferation and blocks the cascade of pro inflammatory mediators. Also, it mitigates brain damage by reducing cerebral metabolic requirement; decreasing cerebral edema; inhibiting reperfusion injury; and limiting apoptosis. Despite all goods, hypothermia intervention is not free of complication. Shivering, electrolyte imbalance, hyperglycemia, hypotension, bradycardia, QT prolongation, arrhythmias, bleeding and increased risk of infection are few infrequent and nonfatal side effects of TH (Nolan et al., 2010).First time, neuro-protective effects of TH were acknowledged in 2002, when two independent randomized controlled trials (RCTs) by Bernard et al. (2002) and HACA study group (2002) revealed significant positive outcomes of TH in patients with out of hospital cardiac arrest (OHCA) with an initial rhythm of ventricular fibrillation (VF). In lieu of these findings, in 2003, ILCOR recommended the use of TH in the treatment of adult post CA patients (Nolan et al., 2003). However, the recommendation was restricted to only OHCA victims whose initial rhythm at the time of CA was shockable. Thereafter, in 2010, scientific statement released by American Heart Association endorsed the same recommendation based on the findings of subsequent studies, also expanded the scope of treatment to patients who sustained CA in-hospital and patients who had initial non-shockable rhythm (Nolan et al., 2010). I conducted systematic review on “TH and its impact on neurological and survival outcomes in adult post cardiac arrest patients” to synthesize evidences and consolidate it into protocol form to guide practice. Search engines like PubMed, EMBASE, CINAHL and Cochrane were explored for the period of 2007-2012 using database specific MeSH terms. The search was truncated to RCT, quasi-experimental studies and non-experimental quantitative studies conducted on patients over the age of 18years. After eliminating duplication and the review of abstracts, seventeen articles were found relevant. Of which 10 articles were considered during synthesis process excluding the low quality (III C) evidences. Of ten articles appraised, two included RCTs (Tiainen et al., 2007; Kim et al., 2007); one was quasi-experimental study (Granja et al., 2011); six were retrospective observational studies (Reinikainen et al., 2012; Prior et al., 2010; Pfeifer et al., 2011; Testori et al., 2011; Stub et al., 2011; Van der et al., 2011); and one study had prospective observational design (Storm et al., 2012). Key variables of the research design and the results of the studies are summarized in Appendix A. Out of ten studies, five studies (Reinikainen et al., 2012; Prior et al., 2010; Testori et al., 2011; Stub et al., 2011; Van der et al., 2011) showed statistically significant mortality benefit of TH. Whereas, of eight studies that evaluated neurological effect of the treatment, four revealed statistically significant positive conclusion in favor of TH (Prior et al., 2010; Pfeifer et al., 2011; Testori et al., 2011; Stub et al., 2011). Evidences from the landmark RCTs and this systematic review concluded that there is a substantial evidence to support the use of TH in post CA cases to improve survival and neurological outcome. Nevertheless, favorable evidences are more inclined towards CA patients with shockable rhythm in OHCA. There is limited evidence that support the use of TH in in-hosptial CA and those with non-shockable rhythm. Those with convincing results are observational studies in which the risk of bias cannot be eliminated and causality cannot be established (Prior et al., 2010; Pfeifer et al., 2011). As a result, TH cannot be concluded as a sole and independent predictor of positive outcome in in-patients CA cases. However, this review proclaims the synergic effect of TH with other post ROSC interventions to minimize the neurological damage and improve survival outcomes in in-patient CA group as well. All the studies had vast differences in terms of study deign, rigor, and methodology. To summarize, the studies had limitations like selection bias; lack of control over confounding variables; inadequate standardization of treatment; lack of power analysis; and influence of history as a threat to internal, external and statistical validity of the studies (Burns and Grove, 2009). As a result, this review could not conclude the best induction time, optimal duration of TH, therapeutic range of hypothermia, the rate of rewarming, and the best cooling device to manage TH. Therefore, expert opinion from ILCOR was referenced to extrapolate the window period for induction, timelines for maintenance phase and optimal rewarming rate (Nolan et al., 2010). Theoretical frameworkTransformation of practice in lieu of evidences is a complex phenomenon that requires harmonization between health care system and human being involved in the process (Chapman, 2010). Complex Adaptive Systems (CAS) Theory provides a framework for Clinical Nurse Specialists (CNSs) through which change is better understood, anticipated, designed and embraced (Chapman, 2010). According to her, there are three core principles of CAS: relationships; self-organization; and nonlinear predictability. She elaborates that “CAS is a collection of individuals, whose actions are interconnected (web of relationships) so that agent’s action changes the context for other agent (self-organization) with freedom to act in a way that are not always totally predictable (nonlinear)” (p.100). The author articulates CAS principles in following four steps approach to guide CNS while embarking on change process. According to Chapman (2010), the first step is called assessment, in which change agent identifies potential stakeholders involved during the change process; explores levels of approval needed to execute innovation; and recognizes how new proposition articulate with organizational strategic priority. Second step is referred as diagnosis, in which CNS examines the values and attitudes of the affected stakeholders about the proposed change; assesses organizational structure; and identifies potential barriers, facilitators and attractors, to plan and prioritize actions. In third phase interventions are developed and solutions are tested. This phase involves development of evidence based standards and guidelines; establishment of multidisciplinary group to bolster adoption of innovation; development of system level policies to support change, mobilization of resources to reduce system level barriers; and commencement of methodologies to sustain the program. In final phase, the impact of the program is evaluated through clinical and financial outcomes measurement; and findings are disseminated. Chapman (2010) also emphasizes that CNS competencies defined by The National Association of Clinical Nurse Specialist (2008) are pivotal to addressing the complex components of CAS.InterventionThe implementation of the project mimicked the aforementioned steps proposed in CAS framework. It encompassed need assessment of the institution; multidisciplinary teambuilding; evidenced based protocol development; establishment of mechanism for process monitoring and outcome analysis; resource mobilization; clinical capacity building of the nursing staff; implementation; and measures to ensure sustainability.During the need assessment process, keeping in view the culture and work politics of the institute, influential members were identified necessary for approval, teambuilding and propelling the agenda forward. The team comprised of CPR committee chair, ICU director, and Assistant Nursing Director of critical care units. Later, the team also invited the Nurse Manager and Clinical Nurse Instructor (CNI) of the ICU, who was mainstay to develop a clinical work force. As a next step, evidences extrapolated through systematic review were utilized to formulate TH protocol and was discussed with stakeholder. After, deliberation with the CPR committee chair and ICU director, the protocol was redrafted as a policy document that defined the responsibilities of multidisciplinary team members (Refer Appendix B). A TH monitoring sheet was also developed in consultation with CPR committee chair and ICU nursing team, to meet the monitoring and documentation requirement; and to observe practice variance (Refer Appendix C). The monitoring sheet also included covariates critical for the outcomes analysis. Detailed capital and operational budget spread sheet was prepared and presented to the team to assist in planning and resources allocation (Refer Appendix D). However, keeping in view that ICU was already well equipped, and a number of services proposed in the TH plan were rendered as a part of standard ICU care, the final operational cost narrowed down to 325 USD for the entire treatment, excluding consultation cost. This is far less than one day admission cost of the ICU. Afterward, I embarked on training and development of the nursing staff. Three educational sessions were conducted to prepare the nurses for the required clinical care (n=30). The first session invited CNI and shift in-charges of the ICU (n=8), who were identified to become clinical champions of TH. The session was delivered via Skype through real time communication. Power point presentation, discussion, case based reflection, skills demonstration, and ECG simulator were used as teaching methodologies. Skills certification on operation of cooling device, rectal temperature monitoring, QT analysis, and arrhythmia interpretation was handled on site by CNI. To assess the learning of student, summative evaluation was conducted through post-test (Refer Appendix E). Average post test score of 92% compared to pretest result of 22.9% was appreciating (Refer Appendix F). Course evaluation was also conducted using likert scale of 1-5 (1= poor, 2 = fair, 3 = good, 4 = very good, 5 = excellent). 87% of the participants rated the course as excellent and 12.5% scored it very good (Refer Appendix G). Second and third sessions were conducted onsite by CNI with the assistance of identified champions under my supervision through Skype. Subsequently, trained nurses would undergo clinical certification on at least one patient. Additionally, the protocol was also disseminated to the members of CPR and ICU committee, ICU consultants and residents. Involvement of clinical and administrative leaders in a TH task force; use of evidence based recommendations; utilization of policy framework to guide practice; development of clinical champions; economic operationalization of the project; and mechanisms of outcome analysis, all these interventions are geared to sustain the program. FindingsTo date, TH has been successfully implemented on one patient and the clinical result has been appreciating. To evaluate the overall outcome of the pilot project, survival outcomes of all inductees would be assessed at discharge and at 6 months through physical evaluation and telephonic follow ups respectively. Thereafter, statistical analysis would be pursuit with the help of statistician. The survival outcome at discharge would be measured using logistic regression. To eliminate the influence of potential confounder or effect modifier on association between TH and the outcome, adjusted multi-variate logistic regression analysis would also be performed, controlling for covariates like duration of CPR, initial rhythm, blood glucose level, arterial oxygen level, and mean arterial pressure, gender, age and acuity level. Additionally, survival outcome at 6 months would be determined using cox regression analysis adjusted for above listed variables. Neurological outcome, which is operationalized by using Pittsburgh Cerebral Performance Category (CPC) tool, would be analyzed through chi-square. The tool is valid and reliable to measure the phenomena of interest in post CA cases; is easy to administer on site and over the phone; and is most frequently used in post CA studies (Tiainen et al., 2007). The above mentioned findings would also be studied using post hoc stratified analysis to examine the difference of the outcomes based on shockable and non-shockable rhythm. We also intent to measure secondary outcomes like length of stay in hospital and cost of care, which would then be compared with retrospective cases of CA. DiscussionTherapeutic effects of hypothermia post CA is convincing, but is more pronounced in patients with shockable rhythm post OHCA. Of 10 studies reviewed, none of the RCTs have examined the outcome benefit of TH in in-patient CA victims. Only three observational and one quasi experimental study included both in and OHCA case. Of those, Prior et al’s. (2010) study revealed statistically significant mortality and neurological benefit and Pfeifer et al’s. (2011) study showed substantial neurological advantage but only in case of shockable rhythm. Limited body of knowledge and lower level of evidences supporting the use of TH in non-shockable rhythm and in-hospital CA may provoke skepticism and doubts about the benefit of hypothermia in this group, as both these cohorts may have different acuity level and may respond differently to post resuscitation care. Thus, there was a concern raised during planning phase as if the evidences are adequate to support the ethical premises of the project or if ethical approval is warranted for pilot project. Richardson (2010) guides to the solution of the problem. According to her, the body of knowledge might be limited or incomplete related to several practice concerns. She suggests that in such scenario, CNS’s should utilize interventions recommended by expert panel, while more rigorous research data is available to guide practice. To seek validation, the Hospital’s Ethics Review Board was also consulted, who also denied the need for ethical approval. However, we did incorporate informed consent by next of kin as guided by hospital’s consent policy. Cost implication always surface as a barrier when translating evidences generated from developed countries to the resource poor health care systems. In most of the studies reviewed, TH is introduced and controlled through sophisticated auto-regulating cooling system like Arctic-Sun. Disposable pads of this cooling system alone costs more than total operational cost proposed in the plan. Similarly, esophageal temperature monitoring system, though not a heavy budget item was disregarded as an unplanned request in the middle of a fiscal year. Blue and Fisher (2010) assert that CNS can positively influence health care economy through critical review of equipment acquired for the patient care. Thus, instead of Arctic-Sun device, I proposed relatively cost efficient, locally made K-thermia cooling system for temperature maintenance, which is being used for both cooling and warming purposes for several years in the ICU. The alternate cooling methodologies are supported by systematic review of Walters et al. (2011), who conclude that automated cooling systems are not absolute necessity and TH can still be achieved using conventional cooling measures like chilled intravenous fluid, ice bags and other surface cool blankets. Likewise, alternate to esophageal temperature we incorporated rectal temperature monitoring that is already available in the ICU. This modification was in lieu of Lefrant et al’s. (2007), who suggest that rectal temperature, though not as precise as esophageal temperature, but is more reliable than axillary probes to monitor core body temperature. Change process is often time consuming and exhilarating. The utilization of CAS theoretical framework invites CNS to critically analyze the situation, organize them and plan proactively to increase the odds of success while introducing innovation. This framework, if operationalized in its true sense, has potential to articulate and enhance major key competencies of CNS like consultation, system leadership, researcher, moral agent, coaching, and collaboration. (The National CNS Competency Task Force, 2008)ConclusionThis project will mark a beginning for several events at AKUH. The pilot project has not only introduced the novel evidence based intervention for post CA patients, but has also ameliorated the outcome monitoring system of resuscitation service at AKUH. 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Cognitive and neurophysiological outcome of cardiac arrest survivors treated with therapeutic hypothermia. Stroke; a Journal of Cerebral Circulation, 38(8), 2303-2308. doi: 10.1161/STROKEAHA.107.483867 Walters, J. H., Morley, P. T.,& Nolan, J. P. (2011). The role of hypothermia in post-cardiac arrest patients with return of spontaneous circulation: A systemic review. Resuscitation, 82, 508-516. doi: 10.1016/j.resuscitation.2011.01.021.van der Wal, G., Brinkman, S., Bisschops, L. L., Hoedemaekers, C. W., van der Hoeven, J. G., de Lange, D. W., . . . Pickkers, P. (2011). Influence of mild therapeutic hypothermia after cardiac arrest on hospital mortality. Critical Care Medicine, 39(1), 84-88. doi: 10.1097/CCM.0b013e3181fd6aef Summary of Evidences1stAuthorStudy design /Control/LOESampleTH vs NTType of CA rhythmSite of CACooling deviceInduction time from ROSCTarget temp in TH group /Mean tempCooling durationMean temp in NT group Survival OutcomeTH vs NTNeurological OutcomeTH vs NTTiainen (2007)Randomized prospective trial(I B)N = 70TH = 36NT= 34Shockable*OHCAExternal deviceNA32-34C/33+1C24hrsMean NA^NTMean NA[SO] ( 28 vs 22, p = 0.226)93% vs 78%, no P valueCognitive outcome:Intact or subtle deficit67% vs 44%, NSKim (2007)Randomized controlled trial(I C)N = 97TH = 49NT = 48All rhythms*OHCASC and CSNA32-34C/Mean NANA×NTMean NA[SO] VF group: 66% vs 45%, p= NSNon VF group:6% vs 20%, p = NSAdjusted OR for survival = 0.91, 95% CI=0.28 to 2.96Awakening in VF patients:69% vs 45%, P = 0.15Awakening in Non-VF patients:9% vs 23%, P = 0.13Granja (2011)Before and after(II B)N = 130TH = 55NT =75All rhythmsIN and **OHCASC and CS4+2.25hrs32-34C/Mean NA15.1+4.1hrs×NTMean NA[SO] 60% vs 39% ,P= 0.1626 vs 21 patients, NSReinikainen 2012Retrospective observational with HC (III B)N = 3958TH = 3072NT = 886ShockableOHCANANANA32-34C/Mean NANA×NTMean NA[M]51.1% vs 57.9%, P< 0.001Adjusted OR = 0.54, 95 % CI= 0.45-0.64, P < 0.001)NAPrior(2010)Retrospective cohort with HC(III B-/C)N = 456TH = 44NT = 368All rhythmsIN and **OHCASC2.8hrs (0.2-7.832-34C/Mean NA9-28hrs×NTMean NA[SO] Within TH group:Shockable vs non shockable61% vs 24%, P < 0.0543% vs 13%, P < 0.001Pfeifer(2011)Retrospective observational with HC(III B)N = 210TH = 143NT = 67All rhythmsIN and **OHCASC and CS4-6hrs32-34C/33+1C24hrsMean NA^NTMean NA[SO] All patients:48.2% vs 44.8%, P = 0.659For shockable :26.4% vs 28.6%, P = 0.807For non-shockable:70.4% vs 56.4%, P = 0.149)Better in VF patient within TH group (p < 0.001)Testori,(2011)Retrospective cohort with HC(III B)N = 374TH =135NT= 239Non Shockable*OHCASC and CS1.4hrs32-34C/33+1C24hrsMean NA^^NTMean NA[SO] Adjusted OR = 0.56, 95% CI, 0.34 – 0.93Adjusted OR = 1.84, 95% CI, 1.08 – 3.13Storm (2012)Prospective observationalwith HC(III B)N = 175TH = 87NT = 88Non ShockableIN and **OHCASC and CSNA32-34C/Mean NA24hrsMean NA×NTMean NA[SO] Adjusted HR 0.98, 95% CI = 0.53-1.5, p = 0.6327.5% vs 18.2%, P = 0.175Stub (2011)Retrospective observationalwith HC(III B)N = 125TH = 81NT = 44Shockable**OHCASC and CSNA32-34C/Mean NANA×NTMean NA[SO] 64% vs 39%, p <0.01Unadjusted Odds ratio 2.7, 95% CI = 1.1 – 6.4 , P = 0.0257% vs 29%, p < 0.01Van der (2011)Retrospective observationalwith HC(III B)N = 5317TH= 3770NT = 1547All rhythms**OHCANANA33-36.4CNA^^NTMean NA[M] 65% vs 72%, p = NA Adjust OR= 0.8, 95% CI= 0.65 – 0.98, p = 0.29NALOE= Level of evidence; CA=Cardiac arrest; ROSC=Return of spontaneous circulation; SO=Survival Outcome; M=Mortality Outcome; All rhythms= VT/VF/PEA/Asystole; TH=Therapeutic hypothermia; Shockable =VT/VF; Non Shockable=PEA/Asystole; NT=Normothermia; ^ hyperthermia controlled; ^^ hyperthermia not controlled; × hyperthermia information NA; *OHCA=Out of hospital cardiac arrest(witnessed); **OHCA=Out of hospital cardiac arrest(witnessed and un witnessed);IN=In-hospital; NS=Not significant; NA=Not available/assessed; SC=Surface cooling; CS=cold saline/fluids; R=hazard ratio; HC=Historical controlPolicy Title: Therapeutic hypothermia in adult post cardiac arrest patientsPOLICY STATEMENTThe policy provides guidelines for the use of therapeutic hypothermia in adult patients who have sustained cardiopulmonary resuscitation with a return of spontaneous circulation (ROSC). PURPOSEThe purpose of therapeutic hypothermia is to minimize post cardiac arrest brain injury in order to improve neurological and survival outcomes of post cardiac arrest patients.APPLICABILE TO The policy applies to patients arriving in ICU through ER or in-patient units who sustained witnessed or un-witnessed cardiopulmonary arrest and meet inclusion and exclusion criteria for therapeutic hypothermia.Therapeutic hypothermia should not be initiated in uncontrolled settings like general ward, special care unit or emergency department. DEFINITIONSTherapeutic hypothermia: Is a controlled lowering of patient’s core temperature to 32C – 34C ( 33C). Core temperature: Represents temperature of internal visceral organs. Typical measurement sites are rectal, pulmonary artery catheter (PAC), esophageal and bladder. Peripheral temperature: Sources of peripheral temperature monitoring include oral and axillary routes. They can be used to estimate core temperature with a consideration that peripheral temperature reading may lag behind core temperature changes. Rewarming: Is a passive return of body temperature to 36C.INDICATIONSInclusion criteria:Adult patients (over age of 18years) whose initial cardiac arrest rhythm is Ventricular Fibrillation (VF) or Pulseless Ventricular Tachycardia (VT). Patients who had Pulseless Electrical Activity (PEA) and Asystolic arrest may also benefit from the therapeutic hypothermia and should be considered for the therapy.ROSC following CPR within 60 minutes of collapse. Persistent coma following ROSC. It is defined as inability to follow commands which is not attributed to pre-cardiac arrest medical condition. Exclusion criteria:Shock that is refractory to vasopressors, is a relative contraindication to therapeutic hypothermia. Patients with terminal illness or multi-organ dysfunction.Therapeutic hypothermia should not be offered to patients with following clinical manifestations.Persistent life threatening arrhythmias post ROSCPregnancyTime laps of more than 12 hours from ROSCPregnancy (All female patients of child bearing age must be checked for urine hCG)Primary coagulopathy or uncontrolled bleeding. Patients with DNR.Patients with no flow time more than 60 minutesPatient with traumatic brain injuryNote: Patients who have received thrombolytic agents or who are on antiplatelet/anticoagulant therapy as deemed necessary to treat a primary cardiac condition, is not a contraindication to cooling. RESPONSIBILITY ICU Medical/Anesthesia teamICU intensivist/resident would determine the appropriateness of therapeutic hypothermia use for an individual patient against the set inclusion and exclusion criteria at the time of ICU admission. ICU intensivist/ ICU resident would communicate primary team and patient’s family members about the purpose of the treatment and would obtain written consent from the family. ICU intensivist/ ICU resident would ensure that the base line clinical assessment is done; ECG is reviewed for QT interval and arrhythmia; and required lab investigations are followed. ICU resident would prescribe the written order for therapeutic hypothermia, cold normal saline /ringers lactate infusion, sedation and muscle relaxant as indicated. ICU resident would insert arterial and central line for monitoring.ICU intensivist/ ICU resident would perform reassessment and manage complications associated with therapeutic hypothermia. ICU Nursing TeamICU head nurse (HN) /clinical nurse instructor (CNI)/team leader would determine at the time of booking if patient is a potential candidate for therapeutic hypothermia, would inform ICU resident and would expedite the transfer process. Nurses who have attended unit specific training on therapeutic hypothermia will be responsible to implement the protocol in conjunction with head nurse/clinical nurses instructor/team leader and ICU consultant/resident.Assigned nurse would ensure that assessment time lines and monitoring recommendations are followed during pre-indication, induction, maintenance and rewarming phase.Assigned nurse would ensure that documentation is done as per defined frequency. CPR CommitteeCPR committee chair/co-chair in coordination with ICU medical director, nurse manager/ CNS would be responsible to oversee the quality assurance issues related to therapeutic hypothermia, monitor neurological and survival outcomes of patients and present trends to the leadership. PROCEDURE General guidelinesThe patient must be intubated, mechanically ventilated and on continuous cardiac monitoring. Cooling should be initiated as soon as possible, preferably within 4-6 hours of ROSC.Patient should be cooled as soon as possible to achieve the target temperature of 32C – 34C ( 33C) within 4-6 hours of initiation of initiating cooling measures. Target temperature should be maintained for 24 hours, with time beginning once patient reaches the goal temperature. To optimize the positive outcomes of the hypothermia take measures to maintain MAP 65-100mmHg; urine output > 0.5 ml/kg; CVP 8-12 mmHg; PaO2 between 80-100mmHg,O2 saturation 94%-96%; control hyperglycemia following target blood sugar between 110-140 mg/dl.Pre induction phase Establish most appropriate method for continuous temperature monitoring that is rectal, bladder, esophageal or pulmonary artery catheter (PAC). Peripheral temperature should only be used as secondary source to verify temperature and should not be used to guide the therapy. Assess and document patient’s baseline neurological status, vital signs and CVP reading.Obtain base line lab for blood sugar, serum electrolyte, arterial blood gas, coagulation profile and serum lactate. Obtain rhythm strip to determine baseline QT interval and assessment of arrhythmias. Ensure that central line is inserted for volume status monitoring and arterial line is available for blood pressure monitoring and sampling. However, induction of therapeutic hypothermia should not be delayed if the lines are not in place. Note: Arterial line access may be more difficult to obtain due to vasoconstriction, once the target temperature is reached. ETCO2 monitoring may be used to monitor variation in PCO2 during the treatment. Initiation/Induction phaseAdminister chilled (cooled at approximately 4C) Normal Saline or Ringers Lactate that is equal to 30ml/kg over 30 minutes through a peripheral line, after obtaining physician’s order. Assess for evidence of pulmonary edema before, during and after administration of fluid.Avoid using internal jugular or subclavian CVP lines to infuse cold infusion. However, femoral CVP can be used for the same. Initiate surface cooling device (K-thermia) with the goal temperature set on the machine to prevent over cooling. Ensure that water level in K-thermia is filled and device is operated as per manufacturer’s recommendation. Apply ice packs to the neck, torso, armpits, flanks and groin. This method can be used in conjunction with other cooling measures to facilitate the induction process and to attain the goal temperature in a recommended time period.During this phase, continuously monitor patient’s temperature, blood pressure, heart rate and O2 saturations and document every 15 minutes in therapeutic hypothermia monitoring form (Form is in process of development)Monitor CVP and urine output every hour. Assess patient for shivering every hour using Bed Side Shivering Assessment Scale (BSAS). Notify physician if score is more than 0. Use non-pharmacological measures like socks or stocking on the feet and hands. BSASSCOREDEFINITION0NoneNo shivering noted on palpation of the masseter, neck or chest wall and absence of ECG artifacts.1MildShivering localized to neck and/or thorax only. May only be noticed on palpation of or by the presence of ECG artifact. 2ModerateShivering involves gross muscle movement of upper extremities in addition to neck and thorax .3SevereShivering involves gross movement of the trunk and upper and lower extremities Patient should be administered opioids analgesia (fentanyl, morphine sulphate) and hypnotics (propofol) or benzodiazepine (midazolam) to prevent shivering.If shivering occurs despite optimal sedation, neuromuscular blocking agent (pancuronium, vecuronium, atracurium) as a bolus or infusion should be considered. Beware that the duration of action of neuromuscular blocking agent is prolong during hypothermia. In case of refractory shivering Magnesium Sulphate may be considered. Train of Four must be used for patient receiving neuromuscular blockade to prevent under or over dosing of paralytic agent (recommended blockade is 2 out of 4 twitches).Assess patient’s skin integrity every 2 hourly. Monitor and document the temperature reading of the K-thermia every hourlyMaintenance phase Once the target temperature 32C – 34C (33 C) is achieved, hold cooling measures except for K-thermia. Maintain temperature 32C – 34C (33 C) for 24 hours, with time beginning once patient reached the goal temperature.If the temperature rises above 34C during this phase, ice packs may be reapplied to bring temperature to the required range. K-thermia must be stopped if the temperature falls below recommendation range.Continuously monitor patient’s temperature, blood pressure, heart rate, and O2 sats at least every 30 minutes. Pulse oximetry, commonly monitored in the digits, can be inaccurate and unreliable due to vasoconstriction. Thus, an alternate sources like forehead sensor, or ear probe should be used.Monitor CVP and urine output every hour as per ICU protocol.Check placement of rectal temperature probe every 2 – 4 hourly and verify the temperature through secondary temperature source.Check skin integrity every 2 hourly.Assess for shivering at least 2 hourly and PRN during the maintenance phase by using BSAS. Notify physician if the score is more than 0. Manage shivering as described in the induction phase. Continue to document temperature reading on the K-thermia every hourly. Monitor patient for following adverse effects during this phase. xi-a) Bradycardia: often results with cooling process and is usually refractory to atropine. Intervention may not be needed unless it is associated with hemodynamic instability. xi-b) QT prolongation: QT should be monitored and documented every 4 hourly during this phase. If corrected QTc is greater than 500ms or 0.5sec, the physician should be notified immediately, as it may cause Torsades de pointes. Caution: If treatment is aborted due to persistent arrhythmia, rapid rewarming must be avoided. Patient should be rewarmed following the rewarming guidelines.xi- c) Hyperglycemia: hypothermia decreases insulin sensitivity and secretion and causes hyperglycemia. Monitor blood glucose every 2-4 hourly as per patient’s baseline or ICU protocol. If hyperglycemia develops, monitor blood glucose every hourly and initiate insulin therapy as per physician’s order. Note: Due to peripheral vasoconstriction, capillary glucose measurements during hypothermia can be inaccurate. Therefore, it is advised to obtain blood glucose levels using arterial or central line and verify with lab glucose value prior to insulin treatment. xi-d) Electrolyte imbalances: Hypokalemia, hypomagnesemia, hypocalcemia, and hypophosphatemia can occur during cooling phase due to intracellular shift of electrolytes. Check electrolyte every 6-8 hourly or as ordered. Note: Electrolyte shift reverses when the patient is rewarmed. xi-e) Coagulopathies: may occur with hypothermia. Ensure that patient is monitored for signs of bleeding. Apply adequate pressure if new arterial or venipuncture is performed during cooling phase. Check coagulation profile every 12 hour or as ordered. Platelet and coagulation correction would be at the discretion of ICU physician. xi-f) Volume depletion: Hypothermia induced diuresis may occur causing volume depletion. Monitor and document CVP and urine output every hourly along with other hemodynamic parameter. Maintain adequate hydration as per physician order. Rewarming phase Rewarming phase begins upon completion of 24 hours of maintenance phase. ICU consultant/ resident must be notified when rewarming is initiated. Turn off all cooling measure and let the patient rewarm passively to a temperature of 36C. Remove wet sheets and apply blankets, socks and stocking to facilitate warming process.Passive rewarming may take 8-12 hour. Temperature rise should not be faster than 0.25 - 0.5 C per hour. Monitor patient’s temperature, blood pressure, heart rate, and O2 sats and document every 30 minutes. Use of K-thermia or bair hugger should only be reserved if temperature does not rise as per recommendation in initial 6 hours of rewarming phase. Ensure that rewarming does not exceed 0.5 C per hour if any of these devices are used.Monitor and document the temperature readings of K-thermia/Bair Hugger every hourly if it is used to facilitate rewarming.K-thermia/Bair Hugger and all other measures must be stopped once patient’s temperature reaches 36C.Closely monitor patient for following adverse effects during this phase.ix-a) Hypotension: Vasodilation during rewarming phase may cause hypotension. Administered fluid as per physician’s order to keep MAP above 60mmHg. ix-b) Hyperkalemia: Monitor patient for signs of hyperkalemia that may occur due to extracellular shift of electrolyte. Sedation and/or neuromuscular blocking agent (if started earlier) should be maintained till temperature of 36C is achieved. Thereafter, sedation and muscle relaxant can be stopped upon discretion of ICU physician. Efforts must be made to prevent pyrexia (38C) during initial 72 hours from the time of cardiac arrest.References.References are already list under the assignment section. Developed By: Roshan Jan Muhammad58604155651500The Aga Khan University HospitalDivision of Nursing ServicesTherapeutic hypothermia monitoring sheet Date of cardiac arrest: ____________________ Time of cardiac arrest: ____________________ Duration of code: ________________________Time of return of ROSC: ___________________Location of cardiac arrest: Out of hospital In-hospital ______Witnessed: Yes NoInitial Rhythm Requiring Chest Compressions: PEA Asystole Ventricular Tachycardia Torsades de pointes Ventricular FibrillationPre therapeutic hypothermia checksConsent __________ Primary team notified__________GCS: E___M___V___. Pupils (Size and reaction)R________ L _________ECG rhythm:____________________ QT interval: ____Sr. K _______ Sr. Mg _______Sr. Ca ________ Sr. Lactate__________Blood sugar __________CVP_______________ MAP________________CPC Score at discharge_________ 6 months ________ Therapeutic Hypothermia Summary Induction time ______ Time target temperature achieved___Duration of maintenance phase: ___________Duration of rewarming phase: ____________Time38.037.537.036.536.035.034.534.033.833.633.433.233.032.832.632.432.232.031.0S PO2SBPDBPMAPCVPRefloQT Shivering Assessment TimeShivering score Measures taken Cooling Techniques TimeCold NS/RL Ice packs K-thermia (Temp)Time38.037.537.036.536.035.034.534.033.833.633.433.233.032.832.632.432.232.031.0S PO2SBPDBPMAPCVPQT Shivering Assessment TimeShivering score Measures taken Key for measures taken: SB (sedation bolus) SII(Sedation infusion incremented), MB(Muscle relaxant bolus), MgSO4, NPM (Non-pharmacological measures)Cooling Techniques TimeCold NS/RL Ice packs K-thermia (Temp)Lab Investigations Date/Time Blood SugarPotassium Calcium Magnesium Phosphate PlateletPT/INRAPTTNote: The image and the format of the form has distorted during transfer of contentBudget for therapeutic hypothermia service per patientCapital CostBrandEquipmentNo of units requiredCost per unit ($)Total costAlready available in the ICUPhilips Rectal temperature probes1300.00300.00YesK-thermiaCooling device 1 2500.002500.00YesGrasbeyInfusion pump 12000.002000.00YesOperational CostLab investigationsTotal Frequencycost perfrequency($)Total costPart of standard ICU Care-Serum Lactate2816Yes-CBC 41040Once per day is standard of care in ICU-Basic metabolic panel + Mg and phosphate425100Twice per day is standard of care in ICU-Coagulation profile (PT/APTT/INR)41040Once per day is standard of care in ICU-Blood sugar (Finger stick)12112Six per day is standard of care in ICU-ECG 21020Once per day is standard of care in ICUMedicationsQuantityCost per unitTotal costPart of standard ICU Care-Normal Saline drips (1 Liter)155Yes-Sedation/muscle relaxant variablevariable200Variable ?Monitoring servicesQuantityCost per unitTotal costPart of standard ICU CareArrowArterial line17676Standard of care in ICUBDCVP line (triple lumen)14545Standard of care in ICUBDPressure transducer system for arterial line and CVP monitoring1150150Standard of care in ICU- Arterial line and CVP insertion cost 1100100Standard of care in ICUTotal Operational cost = 804Total Operational Cost Excluding Standard ICU Care Elements = 325OthersServiceTotal Hourscharges per hourtotal charges- Telephonic consultation of CNS and training hours 20 hours 40 dollars per hour800NoNote: The capital cost is proposed to offer hypothermia treatment to 2 patients at any given time. Depreciation and recovery elements are not incorporated which are part of detailed financial feasibility report otherwise. For the project, no new items were needed to be purchased as the required items were already available. Operational item list is not exhaustive. Total cost of USD 804 incudes services that are part of routine ICU care regardless of therapeutic hypothermia intervention, therefore, numbers should be interpreted carefully as they are projected for future reference if the service replication is intended in future to the other units. Therapeutic Hypothermia Training Pre and Post Test It is a Class I recommendation of the American Heart Association (AHA) to induce therapeutic hypothermia in adults following cardiac arrest to temperatures of 86.0°F (30°C) to 89.6°F (32°C)87.8°F (31°C) to 91.4°F (33°C)89.6°F (32°C) to 93.2°F (34°C)91.4°F (33°C) to 95.0°F (35°C)This Class I recommendation of the AHA includes maintaining therapeutic hypothermia for how many hours?2 to 44 to 8 8 to 1212 to 24Induced hypothermia is contraindicated in patients who have intracranial hemorrhage.myocardial infarction. atrial fibrillation.diabetes mellitus.During the induction stage, acceptable invasive methods include rapidly infusing lactated Ringer’s solution that has been cooled to37.4°F (3°C)39.2°F (4°C)41.0°F (5°C)42.8°F (6°C)Which of the following invasive lines cannot be used to infused cold saline or Ringers LactatePeripheral linesCentral Venous catheter in femoral veinCentral venous catheter in jugular veinNone of the above Which of the following is not a preferred means of monitoring the temperature of a patient undergoing therapeutic hypothermia is with which type of thermometer.Axillary Esophageal Rectal BladderPatient undergoing therapeutic hypothermia are typically rewarmed over how many hours? 8-12 hours 4-6 hours6-8 hours 12-24 hours Therapeutic hypothermia is most beneficial if it is introduced within _________time of return of spontaneous circulation. 4-6 hours6-12 hours 12-24 hours > 24 hours Which of the following are the side effects during maintenance phase of therapeutic hypothermia. (Select all that applies)Bleeding QT prolongationHypomagnesemia Hyperkalemia BradycardiaTachycardiaHypotensionHyperglycemiaShiveringDiuresisWhich particular rhythm disturbance is most likely to develop during maintenance phase of therapeutic hypothermia Atrial fibrillation BradycardiaJunctional tachycardiaVentricular fibrillation Which of the following are not candidates for therapeutic hypothermia. (Select all that applies)Persistent life threatening arrhythmias post ROSCPregnancyTime laps of more than 12 hours from ROSCPrimary coagulopathy or uncontrolled bleeding. Patients with no flow time less than 60 minutesPatient with traumatic brain injuryWhich of the following is the side effects during rewarming phase of therapeutic hypothermia. (Select all applicable)Bleeding QT prolongationHypomagnesemia Hyperkalemia BradycardiaHypotensionPatient undergoing therapeutic hypothermia are typically rewarmed not more than0.25 C per hour. 0.25 - 0.5 C per hour 0.5 - 0.75 C per hour. 0.75 – 1.0 C per hour. Bedside nurse palpates the patient and notices shivering that is localized to neck and/or thorax along with presence of ECG artifact. How would you rate the shivering using bedside shivering scale. Grade 0 Grade I (Mild)Grade II (Moderate)Grade III (Severe) Which of the following is considered shivering prophylaxis for hypothermia patientsOpioids analgesia, hypnotics or benzodiazepineOpioids analgesia, neuromuscular blocking agent Neuromuscular blocking agent, Magnesium sulphateOpioids analgesia, Magnesium Sulphate Pre and Post test ComparisonQuestionsPre testPost testIt is a Class I recommendation of the American Heart Association (AHA) to induce therapeutic hypothermia in adults following cardiac arrest to temperatures of 25100This Class I recommendation of the AHA includes maintaining therapeu?tic hypothermia for how many hours?12.5100 Induced hypothermia is contraindicated in patients who have 2587 During the induction stage, acceptable invasive methods include rapidly infusing lactated Ringer’s solution that has been cooled to0100Which of the following invasive lines cannot be used to infused cold saline or Ringers Lactate5087Which of the following is not a preferred means of monitoring the temperature of a patient undergoing therapeutic hypothermia is with which type of thermometer3787 Patient undergoing therapeutic hypothermia are typically rewarmed over how many hours? 2575Therapeutic hypothermia is most beneficial if it is introduced within _________time of return of spontaneous circulation. 0100Which particular rhythm disturbance is most likely to develop during maintenance phase of therapeutic hypothermia 3787Which of the following is the side effects during rewarming phase of therapeutic hypothermia. (Select all applicable)25100Patient undergoing therapeutic hypothermia are typically rewarmed not more than087Bedside nurse palpates the patient and notices shivering that is localized to neck and/or thorax along with presence of ECG artifact. How would you rate the shivering using bedside shivering scale. 3787Which of the following is considered shivering prophylaxis for hypothermia patients25100Average Score22.9692.07Which of the following are the side effects during maintenance phase of therapeutic hypothermia. (Select all that applies)NANAWhich of the following are not candidates for therapeutic hypothermia. (Select all that applies)NANANote: Last 2 questions were not included in the analysis because of multiple correct answers.Course Evaluation SummaryQuestions Poor Fair GoodV.Good Excellent TOTALLanguage was clear and understandable000088Presenter was knowledgeable and confident000088Presentation content was clear and understandable000088Presenter was able to facilitate your learning000088Various teaching methods were used 000178Discussion was encouraged000178Presenter was able to hold your interest000088Presenter was sensitive towards individual learners' needs000178Time was utilized effectively000088Presenter was well planned and organized000088Did this presentation prepare you adequately to implement therapeutic hypothermia on patient000358Overall rating for the course 000178Percentage of overall rating---12.5%87%- ................
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