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CTRI Number  CTRI/2018/12/016753 [Registered on: 21/12/2018] Trial Registered Prospectively
Last Modified On: 19/12/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Supraglottic airway devices for general anaesthesia 
Scientific Title of Study   Comparative evaluation of two supraglottic devices in patients undergoing elective surgery 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 Rashmi Salhotra 
Designation  Associate Professor 
Affiliation  University College of Medical Sciences and GTB Hospital, Delhi 
Address  Room No.631 A UCMS and GTB Hospital Dilshad Garden

North East
DELHI
110095
India 
Phone  9911317334  
Fax    
Email  rashmichabra@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rashmi Salhotra 
Designation  Associate Professor 
Affiliation  University College of Medical Sciences and GTB Hospital, Delhi 
Address  Room No.631 A UCMS and GTB Hospital Dilshad Garden

North East
DELHI
110095
India 
Phone  9911317334  
Fax    
Email  rashmichabra@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Anurag Padhy 
Designation  PG Student 
Affiliation  University College of Medical Sciences and GTB Hospital, Delhi 
Address  UCMS AND GTB HOSPITAL, 2ND FLOOR, OT BLOCK, DILSHAD GARDEN

North East
DELHI
110095
India 
Phone  9040734763  
Fax    
Email  akd6020@gmail.com  
 
Source of Monetary or Material Support  
University College of Medical Sciences, Dilshad Garden, Delhi 
 
Primary Sponsor  
Name  University College of Medical Sciences 
Address  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 Rashmi Salhotra  UCMS and GTB Hospital  Department of anaesthesia, 2nd floor ot block, UCMS and GTB Hospital
North East
DELHI 		 9911317334

rashmichabra@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee - Human Research (IEC-HR)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: T300||Burn of unspecified body region, unspecified degree, (2) ICD-10 Condition: T220||Burn of unspecified degree of shoulder and upper limb, except wrist and hand, (3) ICD-10 Condition: T210||Burn of unspecified degree of trunk, (4) ICD-10 Condition: T230||Burn of unspecified degree of wrist and hand, (5) ICD-10 Condition: S423||Fracture of shaft of humerus, (6) ICD-10 Condition: Q716||Lobster-claw hand, (7) ICD-10 Condition: V294||Motorcycle driver injured in collision with other and unspecified motor vehicles in traffic accident, (8) ICD-10 Condition: L609||Nail disorder, unspecified, (9) ICD-10 Condition: S411||Open wound of upper arm, (10) ICD-10 Condition: M678||Other specified disorders of synovium and tendon, (11) ICD-10 Condition: M219||Unspecified acquired deformity oflimb and hand, (12) ICD-10 Condition: W19||Unspecified fall,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  AMBU AURAGAIN  Device will be inserted after induction of GA with patient’s head in sniffing position. After insertion, the device will be inflated with recommended volume of air. The device will be connected to the anaesthesia breathing circuit. 
Comparator Agent  Proseal LMA  Device will be inserted after induction of GA with introducer tool with patient’s head in sniffing position. After insertion, the device will be inflated with recommended volume of air. The device will be connected to the anaesthesia breathing circuit.  
Intervention  Supraglottic airway device insertion  One of the two supraglottic devices will be inserted and the insertion characteristics will be recorded 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA grade
I/II with Modified Mallampatti class I/II who are fasting for at least 8 hours and have
BMI <30kg/m2, undergoing any elective surgical procedure under general
anaesthesia requiring supraglottic airway device insertion. 
 
ExclusionCriteria 
Details  Patients with restricted mouth opening (< 3cm)
Pregnant women.
Known case of chronic obstructive pulmonary disease, Asthma or any other
restrictive or obstructive respiratory pathology.
History of gastroesophageal reflux disorder.
History of esophagectomy, hiatal hernia and any intraoral growth. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Insertion time  Once, after device insertion. 
 
Secondary Outcome  
Outcome  TimePoints 
Ease of insertion  Once, after device insertion 
Number of attempts for successful insertion  Once, after device insertion 
gel plug test  Once, after device insertion 
Ease of gastric tube placement  Once, after gastric tube insertion 
Hemodynamic variables and Ventillatory parameters(HR, SBP, DBP, SPO2, EtCO2)  Baseline, 0mins, 1min, 5mins, 10mins, at the time of removal, 5mins post removal 
Us of manoeuvres  once, after device insertion 
Sore throat incidence.  2hrs post operatively. 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   27/12/2018 
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   Not yet published 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
Rationale: Ambu AuraGain (AAG) and LMA ProSeal (PLMA) are supraglottic devices which can be used for controlled ventilation during general anaesthesia. However, there is limited literature comparing the two devices with contradictory results on the time and ease of insertion of these devices.
Aim: To compare and evaluate insertion characteristics of Ambu AuraGain with LMA ProSeal in patients undergoing elective surgery under general anesthesia.
Primary Objective
To compare the time taken for successful insertion of Ambu AuraGain with LMA ProSeal.
Secondary objectives 
To compare Ambu AuraGain with LMA ProSeal in terms of:
Ease of device insertion.
Number of attempts for successful insertion.
Success rate in first insertion attempt
Ease of insertion of gastric tube.
Haemodynamic changes.
Ease of removal and complications during removal.
Postoperative airway complications.
Setting: The study will be conducted in the Department of Anaesthesiology, Critical Care and Pain Medicine UCMS and GTB Hospital (University of Delhi).
Study design: Randomized comparative study.
Time frame: November 2018 to April 2020
Population / participants: Patients of either sex, between 18-60 years ASA grade I/II with Modified Mallampatti class I/II who are fasting for at least 8 hours and have BMI <30kg/m2, undergoing any elective surgical procedure under general anaesthesia requiring supraglottic airway device insertion.
Exclusion criteria:
Patients with restricted mouth opening (< 3cm)
Pregnant women.
Known case of chronic obstructive pulmonary disease, Asthma or any other restrictive or obstructive respiratory pathology.
History of gastroesophageal reflux disorder.
History of esophagectomy, hiatal hernia and any intraoral growth.
Sample size: 20 patients in each group, a total of 40 patients.
Methods: 
The patients will be assigned to one of two groups using computer generated random number table. 
Group AAG: Ambu AuraGain will be inserted as airway maintenance device
Group PLMA: LMA ProSeal will be inserted as airway maintenance device.
After inducing general anaesthesia either AAG or PLMA will be inserted according to randomisation. Proper placement will be confirmed by auscultation, ETCO2 values. Parameters like Insertion time, Ease of insertion, Ease of gastric tube placement, Haemodynamic variables (SBP, DBP, HR), use of manoeuvres, Number of attempts and rate of successful placement by either technique, Incidence of sore throat and failure of device insertion will be recorded.
Outcome measures:
Ease of device insertion.
Number of attempts for successful insertion.
Success rate in first insertion attempt
Ease of insertion of gastric tube.
Hemodynamic changes. (HR, SBP, DBP)
Ease of removal and complications during removal.
Postoperative airway complications.
Statistical Analysis:
One time measured quantitative parameters which follow the normal distribution will be compared using unpaired Student’s t-test and those which are non-normally distributed will be analyzed using Mann Whitney ‘U’ test. The qualitative parameters will be compared using Chi-square / Fisher’s exact test.
A p-value of <0.05 will be considered significant.

 
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