| CTRI Number |
CTRI/2024/03/063575 [Registered on: 04/03/2024] Trial Registered Prospectively |
| Last Modified On: |
04/03/2024 |
| 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 different methods of securing airway in patients undergoing surgery under general anaesthesia |
|
Scientific Title of Study
|
Comparison of airway management with I-gel,Cuffed Laryngeal Mask Airway and Cuffed Endotracheal Tube in patients undergoing surgery under general anaesthesia-A Randomized Clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
JYOLSNA M S |
| Designation |
Post Graduate Trainee |
| Affiliation |
Regional Institute of Medical Sciences, Imphal ,Manipur |
| Address |
Department of Anaesthesiology,Regional Institute of Medical Sciences
Imphal West MANIPUR 795004 India |
| Phone |
6282579872 |
| Fax |
|
| Email |
msjyolsna@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr N Anita Devi |
| Designation |
Professor |
| Affiliation |
Regional Institute of Medical Sciences,Imphal |
| Address |
Department of Anaesthesiology,Regional Institute of Medical Sciences
Imphal West MANIPUR 795004 India |
| Phone |
8787458045 |
| Fax |
|
| Email |
dranitadevin@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr N Anita Devi |
| Designation |
Professor |
| Affiliation |
Regional Institute of Medical Sciences,Imphal |
| Address |
Department of Anaesthesiology,Regional Institute of Medical Sciences
Imphal West MANIPUR 795004 India |
| Phone |
8787458045 |
| Fax |
|
| Email |
dranitadevin@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology,Regional Institute of Medical Sciences ,Imphal,Manipur |
|
|
Primary Sponsor
|
| Name |
Jyolsna M S |
| Address |
Regional Institute of Medical Sciences, Imphal ,Manipur |
| Type of Sponsor |
Other [Self,Post Graduate Trainee] |
|
|
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 Jyolsna M S |
Regional Institute of Medical Sciences,Imphal West,Manipur |
Elective Surgery Operation Theatre Complex (OT 1-8) ,Department of Anaesthesiology,Regional Institute of Medical Sciences Imphal West MANIPUR |
6282579872
msjyolsna@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ethics Board, Regional Institute of Medical Sciences,Imphal,Manipur |
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 |
| Intervention |
Airway will be secured by Cuffed Endotracheal tube. |
Study participants will be randomized into three groups,each group containing 50 groups each.Airway will be secured by Cuffed Endotracheal Tube in Group C.At baseline,Insertion time in seconds,ease of insertion and number of attempts required for Cuffed Endotracheal tube insertion will be noted. |
| Intervention |
Airway will be secured by Cuffed Laryngeal Mask Airway |
Study participants will be randomized into three groups,each group containing 50 patients each.Airway will be secured by Cuffed Laryngeal Mask Airway in Group B.At baseline,Insertion time in seconds,ease of insertion and number of attempts required for cuffed Laryngeal Mask Airway insertion will be noted. |
| Intervention |
Airway will be secured by I-gel |
Study participants will be randomized into three groups,each group containing 50 patients.Airway will be secured by I-gel in Group A.At baseline,Insertion time,ease of insertion and number of attempts required for I-gel insertion will be noted. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients aged between 18 to 60years
2.American Society of Anaesthesiologists status I and II
3.Patients undergoing elective surgical procedure under general anaesthesia of duration 60 to 90 minutes
4.Modified Mallampati Score I and II
5.Thyromental distance above 6.5 centimetre
|
|
| ExclusionCriteria |
| Details |
1.Patients with recognised or threatened risk of gastroesophageal reflux
2.Obese patients with BMI more than 30
3.Pregnant women
4.Patients with co existing cardiac disease
5.Patients on antihypertensives
6.Patients undergoing procedures requiring head and neck manipulation
7.Chronic infection or diseases
8.Patients with history of motion sickness |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Compare I-gel,Cuffed Laryngeal Mask Airway and cuffed Endotracheal intubation with regards to the ease of insertion,insertion time and number of attempts |
Outcome will be assessed after insertion of airway device at baseline. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the hemodynamic changes after insertion of the airway device & associated side effects if any. |
Hemodynamic changes will be assessed after insertion of airway device at baseline,every 1 minute until 5 minutes,every 5 minutes until 30 minutes,every 10minutes until the end of surgery.Side effects like blood on removal of device,hoarseness,dysphagia & sore throat will be noted immediately after removing the airway device & 24 hours after surgery. |
|
|
Target Sample Size
|
Total Sample Size="150" Sample Size from India="150"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
18/03/2024 |
| 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="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Endotracheal intubation is the definitive way of securing the airway during anaesthesia. However, owing to the profound cardiovascular responses and risks of local trauma, in cases of difficult airway scenario and in rare extreme events of unable to intubate, the Supraglottic Airway Devices play a superior role of which I-gel and Laryngeal Mask airway are the two commonly used ones. This will be a randomised clinical trial conducted to compare the airway management with I-gel, Cuffed Laryngeal Mask Airway and Cuffed Endotracheal tube in patients undergoing surgery under general anaesthesia. A total of 150 patients, aged 18-60 years of either sex , undergoing elective surgical procedures under general anaesthesia, with American Society of Anaesthesiologists (ASA) physical status I and II, fulfilling the inclusion criteria and willing to give consent will be enrolled in the study. They will be randomly allocated into three groups, Group A, Group B and Group C whose airway will be secured by I-gel, Cuffed Laryngeal Mask Airway and Cuffed Endotracheal Tube respectively. The number of insertion attempts, ease of insertion and insertion time will be noted and compared in each case.Hemodynamic changes and side effects after device insertion like blood on device removal,hoarseness,dysphagia and sorethroat will be noted and compared. The findings and observations made during the entire study will be tabulated,graphically depicted whenever possible,statistically analysed and inference will be drawn. |