Rajiv Gandhi University of Health Sciences



RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

BANGALORE, KARNATAKA.

PROFORMA FOR REGISTRATION OF DISSERTATION

TOPIC:

COMPARISION BETWEEN I-GEL AND LARYNGEAL MASK AIRWAY -CLASSIC IN PATIENTS UNDER GENERAL ANAESTHESIA WITH SPONTANEOUS VENTILATION- A RANDOMIZED TRIAL

Dr. MOHAN. H. S

POST GRADUATE

DEPARTMENT OF ANAESTHESIOLOGY

K.V.G MEDICAL COLLEGE AND HOSPITAL

KURUNJIBHAG. SULLIA.-574327

D.K.

KARNATAKA.

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

KARNATAKA, BANGALORE

ANNEXURE-II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

| | | |

|1. |NAME OF THE CANDIDATE AND ADDRESS |Dr. MOHAN. H. S |

| | |POST GRADUATE STUDENT |

| | |DEPARTMENT OF ANAESTHESIOLOGY K.V.G MEDICAL COLLEGE AND HOSPITAL |

| | |KURUNJIBHAG SULLIA – 574327 |

| | | |

|2. |NAME OF THE INSTITUTION |K.V.G MEDICAL COLLEGE, SULLIA. |

| | | |

|3. |COURSE OF STUDY AND SUBJECT |M.D. ANAESTHESIOLOGY |

| | | |

|4. |DATE OF ADMISSION TO COURSE |13-10-2011 |

| | |COMPARISION BETWEEN I-GEL AND LARYNGEAL MASK AIRWAY - CLASSIC IN|

|5. |TITLE OF TOPIC |PATIENTS UNDER GENERAL ANAESTHESIA WITH SPONTANEOUS VENTILATION- |

| | |A RANDOMIZED TRIAL |

| | |

| |COMPARISION BETWEEN I-GEL AND LARYNGEAL MASK AIRWAY -CLASSIC IN PATIENTS UNDER GENERAL ANAESTHESIA WITH SPONTANEOUS |

| |VENTILATION-A RANDOMIZED TRIAL. |

| |BRIEF RESUME OF THE INTENDED WORK |

| |6.1 Need For the study |

| |The major responsibility of the anaesthesiologist is to provide adequate ventilation to patient. The most vital element in |

| |providing respiration is maintenance of patent airway. The tracheal intubation is the gold standard method for maintaining |

| |a patent airway during anaesthesia.1 |

| |Laryngoscopy and endotracheal intubation produce reflex sympatho-adrenal stimulation and are associated with raised levels|

|6 |of plasma catecholamines, hypertension, tachycardia etc.2 Airway devices available can be classified as intraglottic and |

| |extraglottic airway devices, which are employed to protect the airway both in elective as well as emergency situations.3 |

| |The laryngeal mask airway (LMA) has been well established for more than a decade and is often used when endotracheal |

| |intubation was not necessarily required4. But usage of LMA is limited by the potential risk of aspiration5 or low pulmonary|

| |compliance.6 |

| |The i-gel (Intersurgical Ltd, Wokingham, UK) is a new, single-use supraglottic airway device, for use during anaesthesia. |

| |Unlike the conventional LMAs, it does not have an inflatable cuff. The i-gel is made from a soft, gel-like, and transparent|

| |medical grade thermoplastic elastomer. The cuff has been designed to create a noninflatable anatomical seal by a |

| |shape which is a mirror |

| |impression of the supraglottic anatomy. The i-gel has several other useful design features including a gastric channel |

| |(which allows early recognition of regurgitation of gastric contents and passage of a drainage tube)7 |

| |The main aim of this study is to compare the i-gel with the LMA Classic in terms of the success of insertion of the device,|

| |gas leak pressure, the incidence of gastric insufflations and postoperative device related complications. |

| | |

| |6.2 Review of the Literature: |

| |In a study done by Helmy et al where they compared i-gel with classical LMA, they concluded that there is no statistically |

| |significant difference between both the study groups regarding blood pressure (BP), heart rate (HR), SpO2, and End tidal |

| |CO2 (EtCO2), but insertion and ventilation was possible at first attempt in 90% patients in i-gel group as compared to 80% |

| |in LMA group.8 |

| |Richez et al carried out one of the earliest study to evaluate the i-gel. They found that insertion success rate was 90%, |

| |insertion was easy and was performed at first attempt in every patient.9 |

| |In a Study done by Keller C, Brimacombe JR et al concluded that for clinical purposes all four tests are excellent but that|

| |the manometric stability test may be more appropriate for researchers comparing airway sealing pressure.10 |

| |In a study done by P. Jindal et al concluded that i-gel effectively conforms to the perilaryngeal anatomy despite the lack |

| |of an inflatable cuff, it |

| | |

| |consistently achieves proper positioning for supraglottic ventilation and causes less hemodynamic changes as compared to |

| |other supraglottic devices.11 |

| |5. In a study done by V uppal et al shows that no significant difference in efficacy of seal and success rate of |

| |first-time insertion between the i-gel and the LMA Unique although the insertion times for the i-gel are significantly |

| |shorter when compared to the LMA Unique. They concluded that the i-gel provides a reasonable alternative to the LMA-U for |

| |controlled ventilation during anaesthesia.12 |

| |6) Bimla Sharma et al conducted a randomized prospective comparative study of proseal LMA versus tracheal tube in |

| |laparoscopic cholecystectomy. In this study success rate of first attempt at insertion was higher for tracheal tube but not|

| |significant (p 0.05) and there was no |

| |evidence of bronchospasm, laryngospasm, regurgitation, aspiration or hoarseness in either group.14 |

| | |

| |8) P.M. Bodrick et al studied 100 ASA grade I and II spontaneously breathing patient using LMA in a variety of surgery.|

| |Clinically satisfactory airway was obtained in 98 patients without need to support jaw, extend the head or to handle the |

| |patient in anyway. Insertion was successful in first attempt in 80%, in second attempt in 70%. In 8 patients the leak was |

| |large enough to make ventilation insufficient, two patients had temporary stridor on removal which quickly settled, and 12 |

| |patients had a temporary sore throat in postoperative period. 15 |

| |9) Tae-Hyung Han et al studied 1067 ASA I and II patients aged 19-40 years weighing 34-84 kg undergoing elective |

| |caesarean section using LMA. They concluded that the insertion was successful in 98% at the first attempt and nine(1%) at |

| |the second or third attempt. Air leakage or partial airway obstruction occurred in 21% patients and 0.7% patients required |

| |intubation. Their study also shows that there were no incidence of aspiration, regurgitation, laryngospasm, bronchospasm in|

| |all insertions of PLMA.16 |

| |10) Study by N. M. Wharton et al evaluated performance of i-gel supraglottic airway device in manikins and |

| |anaesthetized patients when used by novices medical students, non anaesthetist physicians and allowed health professional |

| |all unfamiliar with the I-gel. 80% of i-gel was placed in manikins on first attempt with median insertion time of 14 sec |

| |(range 7-45). 82.5% i-gel were placed in healthy anaesthetized patients and 15% on the second attempt. Median airway seal |

| |was 20cmH2O (13-40) one case of regurgitation and partial aspiration occurred 17. |

| | |

| |6.3 Objectives of the study : |

| |To compare the ease of insertion and incidence of gastric insufflations between i-gel and the LMA-Classic during |

| |anaesthesia in spontaneously breathing patients. |

| |To compare haemodynamic changes and postoperative device related complications between i-gel and the LMA-Classic during |

| |anaesthesia in spontaneously breathing patients. |

| |MATERIALS AND METHODS |

| |7.1 Source of data : |

| | |

| |The study group will comprise of patients admitted in KVG Medical College & hospital, Sullia, for various elective |

| |surgeries between December 2011 and June 2013. |

| | |

| |7.2 Method of Collection of Data : |

| |Inclusion Criteria |

| |Patients aged between 18-60 years |

| |ASA I-II |

| |Body mass index (BMI) between 20-25kg/m2 |

| |Scheduled for elective surgeries |

| | |

| |Exclusion Criteria |

| |Patients having any abnormality of the neck, |

| |Mouth opening ≤ 2 cm |

| |Upper respiratory tract infections |

| |Intra abdominal surgeries |

| |History of obstructive sleep apnea |

| |Patients who underwent thoracic, abdominal and neurosurgery operations |

| |History of allergy to one or more drugs and latex. |

| |Duration of surgery >2hrs |

| |LMA or i -gel placements had failed after three attempts |

| |Study design, sample size and sampling procedure: |

| |A prospective, randomized, case control study on 100 patients. Patients who are selected for the study will be randomly |

| |allocated to following two groups of 50 each. |

| |Group-A: Patients received anaesthesia with LMA Classic |

| |Group-B: Patients received anaesthesia with I -Gel |

| | |

| | |

| |Study procedure: |

| |Following approval of the Ethical Committee of KVG Medical College & Hospital, Sullia and obtaining written informed |

| |consent from patients, hundred patients belonging to ASA I-II, aged between 18-60 years scheduled for elective |

| |surgeries will be enrolled in the study. |

| |Preoperative assessment and medication: |

| |Complete medical history and physical examination will be done for all patients, including assessment of vital signs and |

| |airway assessment. After arrival in the pre-anaesthetic area, the patients will be given. Inj. Metaclopramide 10 mg. i.v. 1|

| |hr before induction and Inj Glycopyrolate 0.2 mg with inj. midazolam 1.5 mg i,v just before induction as premedication. |

| |After shifting patients inside the operation theatre, preoxygenated for 3 minutes, and anaesthesia will be induced with |

| |propofol 2.5 mg/kg and fentanyl lµg/kg intravenously. |

| |Device insertion: |

| |After an adequate depth of anaesthesia had been achieved, each device will be inserted by the same senior anaesthetist, In |

| |group A, the LMA-Classic will be inserted according to the manufacturer's instruction manual. A size 3 or 4 LMA will be |

| |used for adult females and a size of 3, 4 or 5 will be used for adult male. The LMA cuff will be inflated with 20 ml; 30 |

| |ml; 40 ml; for size 3; 4; 5; respectively as recommended by the manufacturer18. |

| | |

| | |

| |For patients of group B, the I-gel size 3, 4 will be inserted according to the manufacturer's instructions.9 |

| |If it is not possible to insert the device or ventilate through it, two more attempts of insertion will be allowed. If |

| |placements had failed after three attempts, the case will be abandoned and the airway will be maintained through other |

| |airway device as suitable and this case will be considered as a failed attempt. |

| |Maintenance of anaesthesia; |

| |After securing the device, spontaneous ventilation in oxygen, nitrous oxide 70 vol% (N2O) and Isoflurane 0.8-1% will be |

| |started. Ventilation will be judged to be optimal if the following four tests will be passed: (i) adequate chest movement; |

| |(ii) stable oxygenation SpO2 not less than 95%; (iii) "square wave" capnography and (iv) normal range end tidal CO2. |

| |Removal of the device |

| |At the end of the operation, anaesthetic agents will be discontinued, allowing smooth recovery of consciousness. The device|

| |will be removed after the patient regains consciousness spontaneously and responds to verbal command to open the eyes. |

| |Dysphagia, dysphonia, nausea, vomiting and trauma to mouth, tooth or pharynx and sore throat will be recorded and will be |

| |reassessed within 24 hours. |

| | |

| | |

| |Parameters measured |

| |Monitoring equipments will be attached to the patient including 5 leads ECG, non-invasive blood pressure, pulse oximetry. |

| |Manometer will be connected to the proximal end of Magill circuit to measure the airway pressure. The following parameters |

| |will be measured. |

| |Heart rate, mean arterial pressure, end-tidal CO2 tension and oxygen saturation (SpO2) at baseline, after insertion of |

| |device, during surgery, at end of surgery and after removal of device. |

| |"The leak pressure by closing the expiratory valve of the Magill circuit at a fixed low gas flow (3L/min), observing the |

| |air-way pressure at which equilibrium will be reached. At this point gas leakage will be heard at the mouth, at the |

| |epigastrium (epigastric auscultation) or coming out the drainage tube (I-gel group), manometric stability test is one of |

| |the most reliable test.10 |

| |Number of insertion attempts and each attempt duration (time from picking up the device until attaching it to the breathing|

| |system in seconds). |

| |Incidence of airway complications caused by supraglottic devices. |

| |Post-extubation cough, breath holding or laryngospasm, |

| |Presence of blood on the I-gel or LMA |

| |Lip and dental injury. |

| | |

| |5. Each patient will be questioned to determine the following complications (in recovery room and 24 hours |

| |postoperatively): |

| |Sore throat (constant pain, independent of swallowing), |

| |Dysphagia (difficulty or pain with swallowing), |

| |Dysphonia (difficulty or pain with speaking), |

| |Numbness of the tongue or the oropharynx, |

| |Blocked or painful ears |

| |Follow- up: Yes |

| |Follow –up- period :24 hours in post-operative ward |

| |Statistical analysis: |

| |The data will be analyzed using SPSS version 11.5 software for windows 7. For categorized parameters chi-square test will |

| |be used, Fisher exact test will be used for data less than 5 in each cell, while for numerical data t-test will be used to |

| |compare two groups. The level of significant used will be p ................
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