| CTRI Number |
CTRI/2024/03/063693 [Registered on: 06/03/2024] Trial Registered Prospectively |
| Last Modified On: |
26/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device Surgical/Anesthesia Other (Specify) [supraglottic airway devices] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Which among the airway devices—I-Gel®, Blockbuster®, and Baska Mask—provides better sealing pressure in elderly patients under general anesthesia? |
|
Scientific Title of Study
|
Comparison of oropharyngeal leak pressure between the I-gel®, Blockbuster® and Baska Mask supraglottic airway devices during general anaesthesia in the elderly population. A randomised controlled 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 |
Sovan Kumar Subudhi |
| Designation |
Junior Resident |
| Affiliation |
AIIMS PATNA |
| Address |
Department of Anaesthesiology,OT Complex, 5th floor,AIIMS Patna Phulwari Sharif,Patna
Patna BIHAR 801507 India |
| Phone |
9439691500 |
| Fax |
|
| Email |
sovan.subudhi9@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DrRajnish Kumar |
| Designation |
Additional Professor |
| Affiliation |
AIIMS PATNA |
| Address |
Department of Anaesthesiology,OT Complex, 5th floor,AIIMS Patna Phulwari Sharif,Patna
Patna BIHAR 801507 India |
| Phone |
7783865337 |
| Fax |
|
| Email |
drrajnishkumar@aiimspatna.org |
|
Details of Contact Person Public Query
|
| Name |
DrRajnish Kumar |
| Designation |
Additional Professor |
| Affiliation |
AIIMS PATNA |
| Address |
Department of Anaesthesiology,OT Complex, 5th floor,AIIMS Patna Phulwari Sharif,Patna
Patna BIHAR 801507 India |
| Phone |
7783865337 |
| Fax |
|
| Email |
drrajnishkumar@aiimspatna.org |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology, All India Institute of Medical Sciences,Patna,
Phulwarisharif,Bihar,India pin:801507 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences ,Patna |
| Address |
Department of Anaesthesiology,OT Complex, 5th floor,AIIMS Patna
Phulwari Sharif,Patna
Patna
BIHAR
801507
India |
| 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 |
| DrSovan Kumar Subudhi |
All India Institute of Medical Sciences,Patna |
Room No. 505, IPD 5th floor, OT complex, AIIMS Patna
Patna
BIHAR
801507
India. Patna BIHAR |
9439691500
sovan.subudhi9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,AIIMS PATNA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Age 65yrs
ASA physical status I-II
Elective surgery under General Anaesthesia with anticipated duration of 2hrs in supine position
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
I-Gel® |
Oropharyngeal leak pressure will be measured by closing the pressure release valve and opening fresh gas flow at 3 L/minute.Two readings of oropharyngeal leak pressure and peak pressure will be taken, one after 5 minutes of the insertion of SADs (T1) and the other 20 minutes after insertion (T2) with flow at 2 L/min. |
| Intervention |
Baska Mask |
Oropharyngeal leak pressure will be measured by closing the pressure release valve and opening fresh gas flow at 3 L/minute.Two readings of oropharyngeal leak pressure and peak pressure will be taken, one after 5 minutes of the insertion of SADs (T1) and the other 20 minutes after insertion (T2) with flow at 2 L/min. |
| Intervention |
Blockbuster® |
Oropharyngeal leak pressure will be measured by closing the pressure release valve and opening fresh gas flow at 3 L/minute.Two readings of oropharyngeal leak pressure and peak pressure will be taken, one after 5 minutes of the insertion of SADs (T1) and the other 20 minutes after insertion (T2) with flow at 2 L/min. |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Age more than 65 years
ASA physical status I and II
Elective surgery under General anesthesia with anticipated duration of less than 2 hours in supine position
|
|
| ExclusionCriteria |
| Details |
Laparoscopic surgery
Reduced mouth opening (interincisor distance less than 4cm)
Recent history of upper respiratory tract infection
Body mass index of more than 35
severe symptomatic oesophageal reflux diseases
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the Oropharyngeal leak pressure of I-gel®, Blockbuster® and Baska Mask supraglottic airway devices during general anaesthesia in the elderly population |
5 minutes after supraglottic airway devices
20 minutes after supraglottic airway devices |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare
The insertion time
Fibreoptic scoring (brimacombe scoring)
The peak pressure
Number of attempts
Maneuvers used during insertion
The intraoperative and postoperative anaesthesia related problems
|
intraoperative |
|
|
Target Sample Size
|
Total Sample Size="108" Sample Size from India="108"
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 4 |
|
Date of First Enrollment (India)
|
14/03/2024 |
| 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="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This study is a randomized controlled trial regarding the comparison of oropharyngeal leak pressure between the I-Gel®, Blockbuster®, and Baska Mask supraglottic airway devices during general anaesthesia in the elderly population.The elderly population often presents unique challenges during general anaesthesia due to age-related anatomical and physiological changes.Oropharyngeal leak pressure (OLP) is an essential indicator of airway seal and is directly correlated with successful ventilation during general anesthesia. Limited research has been conducted to compare the oropharyngeal leak pressure of different supraglottic airway devices, specifically in the elderly population undergoing general anesthesia.The sample size was calculated based on the study by Chi et al.; a sample size of 108 patients (36 per group) will be taken, considering dropouts and errors in the sample size calculation.convenient sampling1. The primary objective is to compare the oropharyngeal leak pressure between I-gel®, Blockbuster®, and Baska Mask during general anaesthesia among the elderly age group, and the secondary objective is to evaluate and compare the insertion time,the peak pressure, the number of manoeuvres used during insertion, and the intraoperative and postoperative anesthesia-related problems.The inclusion criteria include patients over 65 years of age, ASA physical status I–II,elective surgery under GA with an anticipated duration of <2 hours in the supine position, and the exclusion criteria exclude patients undergoing laparoscopic surgery,reduced mouth opening (interincisor distance <4 cm), recent history of upper respiratory tract infection, BMI > 35, and severe symptomatic esophageal reflux diseases. Patients meeting the inclusion criteria will be transferred to the operating room (OR).Upon arriving inside the OR, all standard ASA monitors will be attached, and recording of the baseline hemodynamic parameters will be noted.Before inducing the patient, sealed opaque envelopes with allocated groups will be handed over to the anesthesiologist, and the patient will be induced under general anesthesia. An appropriate size of SADs (as per the group allocated) will be inserted. . The size of the SADs will be selected according to the weight of the patient as per the manufacturer’s recommendation. When an audible leak is detected and/or the pressure gauge on the anaesthesia machine displays a stable airway pressure, the value will be recorded as the sealing pressure has been reached. Oropharyngeal leak pressure will be measured by closing the pressure release valve and opening fresh gas flow at 3 L/minute. They won’t be permitted to go over 40 cm H2O. .Two readings of OLP and peak pressure will be taken, one after 5 minutes of insertion of SADs (T1) and the other 20 minutes after insertion.(T2) |