| CTRI Number |
CTRI/2021/03/031714 [Registered on: 04/03/2021] Trial Registered Prospectively |
| Last Modified On: |
03/03/2021 |
| 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 ease of intubation through I-gel versus Ambu Auragain |
|
Scientific Title of Study
|
To compare the ease of intubation through an I-gel versus Ambu Auragain : A prospective randomised study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shuchi |
| Designation |
Junior Resident |
| Affiliation |
government medical college and hospital patiala |
| Address |
Anaesthesia Department
Government Medical College and Hospital Patiala
Anaesthesia Department
Government Medical College and Hospital Patiala
Patiala
PUNJAB
147001
India |
| Phone |
9896438287 |
| Fax |
|
| Email |
duvedishuchi25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tripat Kaur Bindra |
| Designation |
Professor |
| Affiliation |
government medical college and hospital patiala |
| Address |
Department of Anaesthesia and Intensive Care
Government Medical College and hospital
Patiala
Department of Anaesthesia and Intensive Care
Government Medical College and hospital
Patiala
Patiala
PUNJAB
147001
India |
| Phone |
9501017040 |
| Fax |
|
| Email |
tripat_noori@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tripat Kaur Bindra |
| Designation |
Professor |
| Affiliation |
government medical college and hospital patiala |
| Address |
Department of Anaesthesia and Intensive Care
Government Medical College and hospital
Patiala
Department of Anaesthesia and Intensive Care
Government Medical College and hospital
Patiala
Patiala
PUNJAB
147001
India |
| Phone |
9501017040 |
| Fax |
|
| Email |
tripat_noori@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Government Medical College Patiala |
|
|
Primary Sponsor
|
| Name |
Government Medical College Patiala |
| Address |
GMC Patiala |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shuchi |
Rajendra Hospital Patiala |
Anaesthesia Department
Rajendra Hospital and Government Medical College Patiala
Patiala
PUNJAB |
9896438287
duvedishuchi25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Institute Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ambu Auragain |
Ease of intubation through this device and compared with intubation through I-gel |
| Intervention |
I-gel |
Ease of intubation through this supraglottic airway device. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status I/II
Age group 20-60 years |
|
| ExclusionCriteria |
| Details |
Anticipated difficult airway
History of gastroesophageal reflux disease
Any contraindications to use of muscle relaxants
Increased risk of aspiration
Oropharyngeal pathology
Poor lung compliance |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of I-gel and AAG in terms of number of attempts taken for effective supraglottic airway device placement,time to achieve effective ventilation after supraglottic airway device placement,number of attempts for endotracheal intubation,intubating time and number of cases in which fiberoptic bronchoscope is required |
Time taken for supraglottic Airway Device(SAD) placement.
Time taken for intubation through SAD.
Total intubation time.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare haemodynamics and complications with the use of I-gel and AAG as conduit for endotracheal intubation |
To compare haemodynamics with the use of I-gel and AAG as conduit for endotracheal intubation
Vitals(Heart Rate,Blood pressure,Mean arterial pressure,sPO2,ETCO2) will be recorded till the end of surgery and recorded for every 1 minute for first 10 minutes and every 5 minutes for 30 minutes |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
06/03/2021 |
| 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="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The present prospective randomised study will be conducted in 100 patients of age group 20-60 yearsof ASA physical status I and II posted for elective surgery under General Anaesthesia at GMC Patiala. Patients will be randomly allocated into two groups:Group I (I-gel) and group A (Ambu Auragain). After induction of anaesthesia an adequate sized I-gel or Ambu Auragain concordant to patient’s weight will be inserted.After ensuring correct placement of supraglottic airway device by auscultation,lubricated endotracheal tube will be inserted.While leaving ETT in trachea ,SAD will be removed.In case of difficulty help of fiberoptic scope will be taken.The efficacy of I-gel and AAG will be compared in terms of number of attempts taken for effective SAD placement, time to achieve effective ventilation after SAD placement ,number of attempts for endotracheal intubation,intubating time,number of cases in which fiberoptic scope is used,haemodynamics and complications.The data obtained will be analysed statistically. |