RAJIV GNDHI UNIVERSITY OF HEATH SCIENCE



RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA.

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

|NAME OF CANDIDATE AND ADDRESS |DR. KSHAMATA P. BEWOOR, |

| |w/o DR. CHANDRASHEKAR B. KERUDI, |

| |KERUDI HOSPITAL AND RESEARCH CENTRE, EXTENSION AREA, |

| |BAGALKOT -587101 |

| |KARNATAKA |

| | |

|ADDRESS FOR CORRESPONDANCE |DR. KSHAMATA P. BEWOOR, |

| |PG IN PAEDIATRICS, |

| |DEPT OF PAEDIATRICS, |

| |M. S. RAMAIAH MEDICAL COLLEGE, |

| |BANGALORE – 54. |

|NAME OF THE INSTITUTION |MS RAMAIAH MEDICAL COLLEGE |

| |BANGALORE – 54. |

|COURSE OF THE STUDY AND SUBJECT |M.D. PAEDIATRICS |

|DATE OF ADMISSION TO THE COURSE |1-05-2009 |

|TITLE OF THE TOPIC |ROLE OF DEXAMETHASONE IN PREVENTING POST EXTUBATION STRIDOR AND |

| |RE-INTUBATION IN CHILDREN: A RANDOMISED PROSPECTIVE CLINICAL STUDY. |

1. BRIEF RESUME OF THE INTENDED WORK:

1. NEED FOR THE STUDY

Endotracheal intubation is one of the life saving invasive procedures done in the Pediatric Intensive Care Unit in providing care to the critically ill children. It is essential in protecting the airway and mechanically ventilating sick children with severe respiratory diseases and many other conditions leading to respiratory failure. Although its pivotal role is well accepted, the inherent problems like edema and laryngeal injury predisposes to post extubation complications like stridor, need for re-intubation, and delayed complications like laryngeal stenosis, etc. Such complications may prolong the length of stay in intensive care unit, particularly if airway obstruction is severe and re-intubation proves necessary. Studies in pediatric population suggest that incidence of extubation failure with subsequent re-intubation ranges from 14-24 %1, 2.

Corticosteroids are administered before extubation in an effort to avoid the development of post extubation stridor, presuming that reactive edema develops in the glottic or subglottic mucosa because of pressure or irritation from the endotracheal tube. This is based on the beneficial role of steroids in reducing edema and stridor in patients with laryngotracheobronchitis, by virtue of their anti-inflammatory actions. However the current available evidences are inconclusive about the use of steroids to prevent such complications in children. Hence we are undertaking this study in our hospital to find out the efficacy of dexamethasone in preventing early post extubation upper airway complications like stridor and extubation failure in children.

6.2. REVIEW OF LITERATURE:

Laryngeal edema and the resultant stridor are common problems in children following tracheal extubation after mechanical ventilation. Not infrequently, air way compromise necessitates endotracheal reintubation. This sequence of event also occurs in adult, although far less often. Extubation failure, defined as the need for reintubation within 72hrs of removal of an endotracheal tube, is a significant problem in critical care units3. Extubation failure is associated with an increased duration of the mechanical ventilation, higher risk for nosocomial pneumonia, prolonged intensive care and hospital stay and is independently associated with increased mortality3. While there are numerous causes for extubation failure, laryngeal edema, a common complication of prolonged intubation, either causes or contributes to extubation failure in many cases.

Corticosteroids have been investigated as a measure to alleviate laryngeal edema and therefore reduce the rate of extubation failure. Theoretically, corticosteroids can reduce the inflammatory response and decrease edema. Regarding the type of steroids being used, there was no significant difference with use of different corticosteroids (methylprednisolone, dexamethasone & hydrocortisone) on outcome, when compared with placebo, in adults. Dexamethasone was the preferred drugs in many studies in children based on its effect in reducing stridor and laryngeal edema in croup cases.

Indeed, early randomized studies have shown decreases in subjective manifestation of laryngeal edema when corticosteroids were used prior to extubation4. In studies involving children, Anene et al [1996]5 showed a significant reduction in croup and stridor scores at 10 min, 6 and 12 hrs with use of pre-extubation steroids when compared to placebo. But reintubation rates were not statistically significant. Malhotra et al [2009]6 concluded that prophylactic use of intravenous dexamethasone was useful in preventing early post extubation complications in children but not in adults and its use was found to be safe in critically ill children. Similar studies done by Tellez et al [1991]7, Harel et al [1997]8 and Saleem et al [2009]9, did not find any significant difference between the groups. However, no studies have been adequately powered to determine whether the use of corticosteroids influence more clinically important outcome measures, in particular rates of extubation failure.

3. OBJECTIVE OF THE STUDY:

To determine the efficacy of dexamethasone in preventing postextubation stridor and the need for re-intubation in mechanically ventilated children.

7. MATERIALS AND METHODS:

Design of the study: Randomized, prospective, comparative clinical study.

Inclusion criteria: Children requiring mechanical ventilation [elective or emergency] for more than or equal to 48 hrs but less than 7 days and deemed fit for their elective extubation.

Exclusion criteria: Patients with

1. Anatomical defects in the upper airways

2. Pre-existing upper airway disease

3. Prior neck surgeries

4. Prior steroid use

7.1. SOURCE OF DATA

60 children admitted to the paediatric intensive care units of M. S. Ramaiah Hospitals from October 2009 to March 2011, requiring endotracheal intubation and mechanical ventilation for more than or equal to 48 hours but less than 7 days will constitute the study subjects.

7.2. METHOD OF DATA COLLECTION

Children who satisfy the inclusion criteria will be enrolled into the study. Prior informed consent will be taken from the parents/guardians of the patients before enrolling them into the study. The particulars of the patient including name, age, gender, admitting diagnosis will be documented.

Patients will be assigned to 2 groups as per random number table. GROUP-A patients will receive dexamethasone at a dose of 0.5 mg/kg/dose [max. 8mg] at 6hours prior to planned extubation, at extubation, 6 and 12 hours post extubation. GROUP-B patients will not receive steroids prior to extubation. Post extubation both groups will receive oxygen. Nebulizations will be as per need basis.

All intubations will be performed by designated trained personnel. Trachea will be intubated with the standard endotracheal tube size according to their age10.

ET Tube size in mm= Age in years + 4

4

All patients will receive sedation/ analgesia/ muscle relaxation/ nursing care as per standard pediatric care unit protocol.

The decision for extubation will be taken by the pediatric intensive care team. Endotracheal extubation will be followed according to the standard intensive care unit weaning protocol as11-

1. Clinical improvement of the underlying disease:

a. Good spontaneous respiratory efforts

b. Lack of retractions.

c. Resolution of disease

d. GCS score of more than or equal to 11

e. Capillary refill time of ................
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