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CTRI Number  CTRI/2019/12/022367 [Registered on: 13/12/2019] Trial Registered Prospectively
Last Modified On: 05/12/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of three supraglottic devices for airway management during laparoscopy 
Scientific Title of Study   Comparative evaluation of AMBU Auragain, i-gel and LMA Proseal in patients undergoing laparoscopic cholecystectomy under general anaesthesia  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sujata Chaudhary 
Designation  Director Professor 
Affiliation  University College of Medical Sciences 
Address  Department of Anaesthesiology Room No. 400 PCNL OT GTB Hospital Dilshad Garden

North East
DELHI
110095
India 
Phone  9625900800  
Fax    
Email  sujatac462@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sujata Chaudhary 
Designation  Director Professor 
Affiliation  University College of Medical Sciences 
Address  Department of Anaesthesiology Room No. 400 PCNL OT GTB Hospital Dilshad Garden


DELHI
110095
India 
Phone  9625900800  
Fax    
Email  sujatac462@gmail.com  
 
Details of Contact Person
Public Query  
Name  Priyanka Anand 
Designation  PG Student 
Affiliation  University College of Medical Sciences 
Address  Department of Anaesthesiology Room No.400 PCNL OT GTB Hospital Dilshad Garden

North East
DELHI
110095
India 
Phone  9953819933  
Fax    
Email  paanandp60@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology University College of Medical Sciences DIlshad Garden Delhi 
 
Primary Sponsor  
Name  University College of Medical Sciences 
Address  Department of Anaesthesiology 2nd floor ICU Dilshad Garden Delhi 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sujata Chaudhary  UCMS AND GTB HOSPITAL  Room No. 400 PCNL OT 4th floor, Dilshad Garden Delhi
North East
DELHI 		 9625900800

sujatac462@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instituitional Ethics Committee-Human Research   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Ambu Aura Gain  Once, after induction of anesthesia, device will be inserted through the oral cavity and will be removed after the completion of the procedure.  
Comparator Agent  I-gel  Once, after induction of anesthesia, device will be inserted through the oral cavity and will be removed after the completion of the procedure. 
Intervention  One of the three airway devices will be inserted.  After induction of anaesthesia one of the three airway devices will be inserted and the performance of the device will be compared 
Comparator Agent  Proseal LMA  Once, after induction of anesthesia, device will be inserted through the oral cavity and will be removed after the completion of the procedure. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA grade I/II
Modified Mallampatti class I/II
Scheduled for elective laparoscopic cholecystectomy under general anaesthesia 
 
ExclusionCriteria 
Details  BMI > 30 kg/m2
Pregnant women
Known or predicted difficult airway
Known case of COPD, asthma or any other restrictive or obstructive respiratory pathology
Patients at high risk for pulmonary aspiration
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Oropharyngeal leak pressure   After insertion of device
Before CO2 insufflation
Just after insufflation
15 mins after insufflation
30 mins after insufflation
45 mins after insufflation
60 mins after insufflation
75 mins after insufflation
90 mins after insufflation
105 mins after insufflation
120 mins after insufflation
After deflation of abdomen 
 
Secondary Outcome  
Outcome  TimePoints 
Ease of insertion
Number of attempts for successful insertion
Success rate in first attempt
Maneuvers required for insertion
Ease of insertion of gastric tube
 		 Once after successful insertion of device 
Haemodynamic variables and ventilatory parameters  Preoperatively
Baseline
At the time of insertion of device
Thereafter, the readings will be taken at 1,3,5 & 10 mins interval
At the time of removal of device
5 mins after removal of device
 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   23/12/2019 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Rationale: AmbuAuraGain (AAG), i-gel and LMAProseal(PLMA) are some of the supraglottic devices which are used forcontrolled ventilation during general anaesthesia. However, there is limited literature comparing the three devices for theirperformance in laparoscopic surgeries. Whatever studiesare available, their results are contradictory

Aim: To compare and evaluate the performance of three supraglottic devices namelyAmbuAuraGain,i-gel and LMA Proseal in patients undergoing laparoscopic cholecystectomy under general anaesthesia

Primary Objective

To compare the oropharyngeal leak pressure of AmbuAuraGain&i-gel withLMA Proseal.

Secondary Objectives

Insertion characteristics –

Ease of insertion

Number of attempts for successful insertion

Success rate in first attempt

Maneuvers required for insertion

Ease of insertion of gastric tube

Hemodynamic changes

Complicationslike oropharyngeal trauma, sore throat

Setting: The study will be conducted in Department of Anaesthesiology, Critical Care and Pain Medicine, UCMS and GTB Hospital, Delhi

Study design: Randomized comparative study

Time frame: November 2019 to April 2021

Population/ participants: Patients of either gender, between 18-60years ASAgrade I/II with Modified Mallampatti class I/II admitted for elective laparoscopic cholecystectomy under general anaesthesia

Exclusion Criteria:

BMI > 30 kg/m2

Pregnant women

Known or predicted difficult airway

Known case of COPD, asthma or any other restrictive or obstructive respiratory pathology

Patients at high risk for pulmonary aspiration

Sample Size: 20 patients in each group, a total of 60 patients.

Method of Randomization: The patients will be assigned to one of the three groups using computer generated random number table.

Group-A: AmbuAuraGain will be inserted as airway maintenance device

Group-I: i-gel will be inserted as airway maintenance device

Group-P: LMA Proseal will be inserted as airway maintenance device

Methodology:PAC will be done one day prior to surgery, a written informed consent will be taken.In OT, all the routine monitors will be attached and baseline vitals readings will be noted. An intravenous line will be secured. Depending on the randomization, one of the three devices (Ambu AuraGain, i-gel or PLMA) will be examined and prepared as per guidelines. Standard general anaesthesia technique will be given. Supraglottic airway device will be inserted with the patient’s head in sniffing position. Correct placement of device will be confirmed by bilateral chest expansion, auscultation of chest and appearance of first square wave on capnograph on monitor. An orogastric tube of appropriate size will be passed through the drainage tube following lubrication and its position will be confirmed by epigastric auscultation of air.

Outcome Measures:

1.      Oropharyngeal leak pressure  [Primary]

2.      Ease of insertion

3.      Number of attempts for successful insertion

4.      Success rate in first attempt

5.      Maneuvers required for insertion

6.      Ease of insertion of gastric tube

7.      Hemodynamic changes(HR, SBP, DBP)

8.      Complications like oropharyngeal trauma, sore throat

STATISTICAL ANALYSIS

Statistical analysis will be done by using SPSSversion 20.0 or higher. All the 3 groups will be compared by one way ANOVA followed by Tukeys test at 5% level of significance for quantitative parameters.Repeatedly measured parameters will be compared by repeated measure ANOVA.Qualitative parameters will be compared by Chi -square test/Fischer exact test. Bonferroni correction will be done wherever required. A p value of <0.05 will be considered as significant.

 
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