| CTRI Number |
CTRI/2025/02/081275 [Registered on: 25/02/2025] Trial Registered Prospectively |
| Last Modified On: |
23/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the success rate of two methods of removing tube that is put inside the patient during general anaesthesia
|
|
Scientific Title of Study
|
Comparison of success rates of two techniques of extubation over supraglottic airway device
(I-gel) in patients with unanticipated difficult airway
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Eeshwar M V |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Mangalagiri |
| Address |
No. 1051
Dept. of anaesthesiology
AIIMS Mangalagiri
Guntur ANDHRA PRADESH 522503 India |
| Phone |
9740122272 |
| Fax |
|
| Email |
dreeshwarmv@aiimsmangalagiri.edu.in |
|
Details of Contact Person Scientific Query
|
| Name |
Eeshwar M V |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Mangalagiri |
| Address |
No. 1051
Dept. of anaesthesiology
AIIMS Mangalagiri
ANDHRA PRADESH 522503 India |
| Phone |
9740122272 |
| Fax |
|
| Email |
dreeshwarmv@aiimsmangalagiri.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Eeshwar M V |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Mangalagiri |
| Address |
No. 1051
Dept. of anaesthesiology
AIIMS Mangalagiri
ANDHRA PRADESH 522503 India |
| Phone |
9740122272 |
| Fax |
|
| Email |
dreeshwarmv@aiimsmangalagiri.edu.in |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences
Mangalagiri
Guntur district
Andhrapradesh
Pin code 522503 |
|
|
Primary Sponsor
|
| Name |
AIIMS |
| Address |
Mangalagiri
Guntur district
522503 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Eeshwar M V |
All India Institute of Medical Science Mangalagiri |
No. 1051
Dept. of anaesthesiology
AIIMS Mangalagiri
Guntur district
Pincode 522503 Guntur ANDHRA PRADESH |
9740122272
dreeshwarmv@aiimsmangalagiri.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z768||Persons encountering health services in other specified circumstances, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
AEC |
Insert AEC through ETT and remove ETT. Insert I gel over the AEC and follow up the patient at 0, 30 minutes and 60 minutes post surgery. |
| Intervention |
I gel |
Insert I gel at the end of the surgery after removing endotracheal tube and follow up the patient at 0, 30 minutes and 60 minutes post surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients belonging to the age group 18 to 65 years
ASA PS I – III
Intubation difficulty score (IDS) ≤ 5Scheduled for surgery under general anaesthesia
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to compare the success rate of placement of I-gel (SGAD) using the Airway Exchange Catheter (AEC) technique with Asai’s technique in patients with an unanticipated difficult airway using brimacombe score |
From insertion of I gel to appearance of capnograph |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Haemodynamic changes
Number of attempts |
During the insertion of Igel up to 10 minutes post insertion |
|
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
01/04/2025 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
· Preoperative anaesthetic fitness along with written informed consent will be obtained from all the participants by the principal investigator. Premedication in the form of Tablet Alprazolam 0.25 to 0.5 milligram and Tablet Pantoprazole 40 milligram will be administered the night before the surgery as per the institute protocol and patients will be asked to fast as per the standard recommendations. Observer 1 will allocate the participants to either of the group as per the computer generated randomisation table The participant will remain blinded to the group allocation. In the operation theatre, after attaching standard monitoring including pulse oximetry electrocardiography and non-invasive blood pressure. Intravenous line will be secured in the non-dependent arm. Anaesthesia will be administered as per standard protocol by observer 2 . The Intubation Difficulty Sore will be calculated after the successful placement of endotracheal tube. If the score is less than 5 the patient, observer 2 will proceed with the extubation strategy as per the randomisation table. At the end of the surgery observer 2 will ensure adequate neuromuscular blockade and depth of anaesthesia before performing one of the two techniques of extubation. It will be ensured that patients will get 100% throughout the procedure. A weight-based formula as recommended by the manufacturer will be used to choose the appropriate sized Intersurgical gel. After confirming the placement of the Igel, the laryngeal alignment of the SGAD will be determined by passing an adult fibreoptic bronchoscope by observer 2. The fiberoptic bronchoscope will be passed through the airway tube to a position 1 cm beyond the aperture of the tube. The fiberoptic glottic view will be scored using an established scoring system Neuromuscular blockade will be reversed once the train of four count shows at least 3 twitches. The Intersurgical gel will be removed once the patient fulfils the subjective and objective criteria of extubation. Heart rate and blood pressure changes will be monitored while removing the Intersurgical gel every min up to 10 minutes after removal. Observer 1 will follow up with the patient for complications in the postoperative recovery unit. |