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CTRI Number  CTRI/2019/01/016929 [Registered on: 04/01/2019] Trial Registered Retrospectively
Last Modified On: 03/01/2019
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective comparative study 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of two upper airway devices with endotracheal tube in individuals undergoing laparoscopic surgeries 
Scientific Title of Study   A comparative study to evaluate the efficacy of i-gel, proseal laryngeal mask airway and endotracheal tube in individuals undergoing laparoscopic surgeries 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pranshi Jain 
Designation  Primary DNB Anaesthesiology 
Affiliation  Bhagat Phool Singh Government Medical College For Women 
Address  Bhagat Phool Singh Government Medical College For Women Khanpur Kalan Sonipat Haryana
Bhagat Phool Singh Government Medical College For Women Khanpur Kalan Sonipat Haryana
Sonipat
HARYANA
131305
India 
Phone  7056090969  
Fax    
Email  jainpranshi25@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Meenu Agrawal 
Designation  Associate Professor Department Of Anaesthesiology 
Affiliation  Bhagat Phool Singh Government Medical College For Women 
Address  Bhagat Phool Singh Government Medical College For Women Khanpur Kalan Sonipat Haryana
Bhagat Phool Singh Government Medical College For Women Khanpur Kalan Sonipat Haryana
Sonipat
HARYANA
131305
India 
Phone  8059286591  
Fax    
Email  meenu297@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Pranshi Jain 
Designation  Primary DNB Anaesthesiology 
Affiliation  Bhagat Phool Singh Government Medical College For Women 
Address  Bhagat Phool Singh Government Medical College For Women Khanpur Kalan Sonipat Haryana
Bhagat Phool Singh Government Medical College For Women Khanpur Kalan Sonipat Haryana
Sonipat
HARYANA
131305
India 
Phone  7056090969  
Fax    
Email  jainpranshi25@gmail.com  
 
Source of Monetary or Material Support  
Bhagat Phool Singh Government Medical College For Women  
 
Primary Sponsor  
Name  Bhagat Phool Singh Government Medical College For Women 
Address  Khanpur Kalan Sonipat Haryana 131305 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Not Applicable   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Pranshi Jain  Bhagat Phool Singh Government Medical College For Women  Operation Theatre Complex Department Of Anaesthesiology
Sonipat
HARYANA 
7056090969

jainpranshi25@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  A Comparative study to evaluate the efficacy of I-gel, Proseal Laryngeal Mask Airway and Endotracheal tube in individuals undergoing laparoscopic surgeries.  All adult patients undergoing laparoscopic procedures under general anaesthesia using controlled ventilation will be selected. Published data from previous similar studies were used to determine the sample size. In Group-A (I-gel) appropriate sized I-gel will be inserted, and in Group-B (endotracheal tube) patient airway will be secured with laryngoscopy - guided endotracheal intubation and Group-C (Proseal Laryngeal Mask Airway) appropriate sized Proseal Laryngeal mask airway (LMA)will be inserted. Patient selection will be based on certain inclusion and exclusion criteria. 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients who have the ability to give informed consent (i) Age: 18-65 years (ii) ASA I–II (iii) elective surgery (iv) fasting for at least 8 hours.  
 
ExclusionCriteria 
Details  Patients with ASA physical Status III or IV, anticipated difficult airway, mouth opening <2.5 cm, cervical spine disease ,obesity (body mass index > 35 kg/m 2 ), oropharyngeal pathology, emergency cases, cardiopulmonary disease, cervical spine fracture or instability, or at increased risk of aspiration (gastro-esophageal reflux disease, hiatus hernia, full stomach and heartburn), pregnant patients, reported history of any pathology of the neck or airway, history of lung diseases or oesophageal reflux will be excluded. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the efficacy ease and insertion characteristics of supraglottic airway devices & endotracheal tube  120 min 
 
Secondary Outcome  
Outcome  TimePoints 
To determine the hemodynamic changes and ventilation parameters and intraoperative and postoperative laryngo-pharyngeal morbidity and sealing pressure  24 hours 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/12/2016 
Date of Study Completion (India) 31/12/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not Applicable 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Till date, tracheal intubation is considered to be the gold standard for providing seal in laparoscopic surgeries but over a period of time supraglottic airway devices ( like I-gel and  Proseal Laryngeal Mask Airway) have evolved which overcome the disadvantages of endotracheal tube.A comparison of I-gel, Proseal Laryngeal Mask Airway and Endotracheal Tube in laparoscopic surgeries by Rukhsana Najeeb et al in 2015 shows that I-gel was easier to insert with higher success rate in first attempt (92.5%) than Proseal Laryngeal Mask Airway (85%) and endotracheal tube (82.5%).(3) Till date, there are limited studies which have evaluated and compared I-gel, Proseal Laryngeal Mask Airway and Endotracheal tube together for features like leak volume, leak fraction and leak pressure. We will conduct this study to compare supraglottic airway devices like I-gelTM and Proseal Laryngeal Mask Airway with standard endotracheal tube for the parameters that include number of attempts taken for insertion, hemodynamic changes, ventilation parameters, leak volume, leak fraction, leak pressure and postoperative complications during general anaesthesia, in healthy adult patients undergoing laparoscopic surgeries. First 90 patients meeting the inclusion criteria will be enrolled in the study. Group E (n=30) receiving endotracheal tube, Group P (n=30) receiving Proseal Laryngeal Mask Airway and Group I (n=30) receiving I-gel for airway maintenance. Patients will be assessed for insertion characteristics of airway devices (insertion at first attempt with no resistance; insertion at second attempt; insertion at third attempt and failed insertion - insertion not possible), hemodynamic responses (heart rate and blood pressure), ventilation parameters, leak pressure, leak volume, intraoperative and postoperative complications. Statistically significant (p<0.05) increase in heart rate and the mean blood pressure will be observed immediately after insertion, persisted till 5 minutes after intubation and during the time of extubation. We will observe incidence of blood staining of the device, sore throat and dysphasia, coughing, laryngospasm, gastric insufflation, regurgitation, aspiration, billous secretion, stridor, hoarseness of voice, injuries (to lip, teeth, and gum), and dysphonia during perioperative period.

 
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