| CTRI Number |
CTRI/2024/03/064760 [Registered on: 26/03/2024] Trial Registered Prospectively |
| Last Modified On: |
23/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of on ground performance of three airways devices – I-gel, LMA Supreme, Ambu AuraGain in side-up position in children undergoing surgery under complete (general) anaesthesia |
|
Scientific Title of Study
|
A randomised study comparing the clinical performance of three disposable supraglottic airway devices-I-gel, LMA Supreme and Ambu AuraGain in lateral position in pediatric patients undergoing surgery under general anesthesia. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chitra |
| Designation |
Academic Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, Bhopal |
| Address |
Third Floor, Hospital Complex, Department Of Anaesthesiology (Near AB3 Medical ICU), All India Institute of Medical Sciences, Saket Nagar, Bhopal
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
8332910052 |
| Fax |
|
| Email |
chitra.jr2023@aiimsbhopal.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Zainab Ahmad |
| Designation |
Additional Professor |
| Affiliation |
All India Institute Of Medical Sciences, Bhopal |
| Address |
Third Floor, Hospital Complex, Department Of Anaesthesiology (Near AB3 Medical ICU), All India Institute of Medical Sciences, Saket Nagar, Bhopal
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
8860048951 |
| Fax |
|
| Email |
drzainabhaq@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Zainab Ahmad |
| Designation |
Additional Professor |
| Affiliation |
All India Institute Of Medical Sciences, Bhopal |
| Address |
Third Floor, Hospital Complex, Department Of Anaesthesiology (Near AB3 Medical ICU), All India Institute of Medical Sciences, Saket Nagar, Bhopal
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
8860048951 |
| Fax |
|
| Email |
drzainabhaq@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences,Saket Nagar,Bhopal,Madhya Pradesh, India - 462020 |
|
|
Primary Sponsor
|
| Name |
Dr Zainab Ahmad |
| Address |
Dr Zainab Ahmad, Additional Professor, Department of Anaesthesiology, AIIMS,Saket Nagar,Bhopal, M.P. , India - 462020 |
| 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 Chitra |
All India Institute of Medical Sciences, Bhopal |
OT 6 and OT 8, Modular OT Complex 2, Second Floor, Department of Anaesthesiology
Bhopal
MADHYA PRADESH |
8332910052
chitra.jr2023@aiimsbhopal.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee - Student Research (IHEC-SR), AIIMS, Bhopal |
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 |
Ambu AuraGain and LMA Supreme |
After insertion of the above devices under general anaesthesia, oropharyngeal seal pressure will be measured by equilibrium airway pressure method in supine and lateral position.
The process will take 10-15 minutes during the process of induction of general anaesthesia to the patient. It will not cause delay for surgical side to take over.
Duration of above will be for 1 year 6 months from the date of CTRI approval. |
| Comparator Agent |
I-gel |
After insertion of the above devices under general anesthesia, oropharyngeal seal pressure will be measured by equilibrium airway pressure method in supine and lateral position. The process will take 10-15 minutes during the process of induction of general anaesthesia to the patient. It will not cause delay for surgical side to take over.Duration of above will be for 1 year 6 months from the date of CTRI approval. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
1 ASA I and II
2 Patients undergoing elective day care under general anaesthesia in which the choice of airway device has already been decided as a disposable second generation supraglottic airway device and who require lateral position intraoperatively
3 Weight more than 10 kgs up to 25-35 kgs |
|
| ExclusionCriteria |
| Details |
1.Difficult airway.
2.Active Upper respiratory tract infection (URTI)
3.Alimentary tract pathology
4.Cervical spine pathology Anticipated
5.Raised Intra-abdominal pressure.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Oropharyngeal seal pressures (cm H20) of Ambu AuraGain, LMA supreme, I-gel in lateral position using equilibrium airway pressure method, measured by reading (centimetres of H2O) displayed on ventilator screen (Drager Primus); |
Oropharyngeal seal pressures (cm H20) of Ambu AuraGain, LMA supreme, I-gel in lateral position using equilibrium airway pressure method, measured by reading (centimetres of H2O) displayed on ventilator screen (Drager Primus). The OSP will be checked at 10 mins after insertion , 1st minute after lateralisation, 5th minute after lateralisation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To determine the OSP of the mentioned devices in supine position after 10 mins of insertion of the airway device
2.Time taken and number of attempts for insertion
3. Device failure rate
4. Need for airway manoeuvres
5. Fractional volume loss
6. Post operative sorethroat, hoarseness |
Baseline, 10 mins, post op 1st hr, 6th hr, 24th hr |
|
|
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 2 |
|
Date of First Enrollment (India)
|
03/04/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
03/04/2024 |
| 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 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
|
Supraglottic airway devices are better alternatives to endotracheal intubation for various reasons. The newer supraglottic airway devices namely - I-gel, LMA Supreme, Ambu Aura Gain, have shown promising results in adult and paediatric patients. In this study, we aim to compare the mentioned devices in lateral position. Once the anaesthesia is induced, alloted device will be inserted and the OSP (cm of H2O) will be measured in supine and lateral positions. A standard anesthesia technique will be followed in all patients included in the study. Written informed consent and thorough preanesthetic evaluation will be done to ensure adherence to inclusion and exclusion criteria. The study will be conducted while routine induction of a case hence, will not require much time and surgeons will be allowed to proceed without much delay. |