| CTRI Number |
CTRI/2024/01/061417 [Registered on: 12/01/2024] Trial Registered Prospectively |
| Last Modified On: |
11/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare two techniques (Triple airway manoeuvre Vs Reverse insertion) for I-gel placement in children under general anaesthesia |
|
Scientific Title of Study
|
Comparison of triple airway manoeuvre and reverse insertion technique for I-gel placement in paediatric patients under general anaesthesia |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjay Johar |
| Designation |
Professor |
| Affiliation |
Pt. B. D. Sharma PGIMS Rohtak |
| Address |
Dept. of Anaesthesiology and Critical Care Rohtak Haryana 124001 India
Rohtak
HARYANA
124001
India |
| Phone |
9416050652 |
| Fax |
|
| Email |
sanjays321@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anamika |
| Designation |
Junior Resident |
| Affiliation |
Pt. B. D. Sharma PGIMS Rohtak |
| Address |
Dept. of Anaesthesiology and Critical Care Rohtak Haryana 124001
Rohtak
HARYANA
124001
India |
| Phone |
8307390679 |
| Fax |
|
| Email |
anamikapgi15@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anamika |
| Designation |
Junior Resident |
| Affiliation |
Pt. B. D. Sharma PGIMS Rohtak |
| Address |
Dept. of Anaesthesiology and Critical Care Rohtak Haryana 124001
Rohtak
HARYANA
124001
India |
| Phone |
8307390679 |
| Fax |
|
| Email |
anamikapgi15@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institutional Pt. B. D. Sharma PGIMS, Rohtak |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology and Critical care Postgraduate Institute of Medical Sciences Rohtak |
| Address |
Pt. B. D. Sharma University of Health Sciences PGIMS Rohtak Haryana |
| 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 Anamika |
Pt. B. D. Sharma PGIMS Rohtak |
Modular OT Complex and Eye Ot, Dept of Anaesthesiology and Critical Care, Postgraduate Institute Of Medical Sciences
Rohtak
HARYANA |
8307390679
anamikapgi15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 2||Placement, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Reverse Insertion Technique |
Standardised anaesthesia protocol will be followed. Patient shall be induced with inhalational anaesthetic agent. After securing I. V. line, propofol and fentanyl shall be administered. Adequate bag and mask ventilation will be checked and atracurium will be given. The size of I-gel will be decided on the basis of patient body weight. Before insertion cuff will be lubricated using a water based lubricant. The lubricated I-gel will be grasped along the integral bite block. Patient will be positioned in sniffing the morning position. I-gel will be inserted with its concavity facing the hard palate like a Guedel’s airway. On reaching pharynx device will be rotated 180 degrees and advanced along the palate until a definitive resistance is felt. The device will be connected to the breathing circuit. Effective ventilation will be defined as the presence of square wave end tidal carbon dioxide waveform and simultaneous bilateral chest expansion.The following manoeuvres will be done in sequential manner to improve ventilation: 1. Chin lift 2. Jaw thrust 3. Head extension 4. Neck flexion 5. Gentle advancement 6. Withdrawal of I-gel will be done to improve ventilation. If the ventilation is not found to be effective even after the manoeuvres, the device shall be taken out and second attempt with a different size I-gel will be taken. The decision to increase or decrease the size of I-gel will be made by attending anaesthesiologist based on clinical judgement. When two attempts with the same technique fail, technique of other group will be used as a rescue technique with the initial I-gel size. Finally if third attempt fail, tracheal intubation shall be performed to secure the airway. After the completion of surgical procedure, standard reversal protocol of the institution shall be followed and patient will be reversed using neostigmine and glycopyrrolate and I-gel shall be removed and examined for presence of blood.
|
| Comparator Agent |
Triple Airway Manoeuvre |
Standardised anaesthesia protocol will be followed. Patient shall be induced with inhalational anaesthetic agents. After securing I. V. line, propofol and fentanyl shall be administered. Adequate bag and mask ventilation will be checked and atracurium will be given. The size of I-gel will be decided on the basis of patient body weight. Before insertion cuff will be lubricated using a water based lubricant. The lubricated I-gel will be grasped along the integral bite block. An assistant shall apply triple airway manoeuvre i.e. head tilt, mouth opening and Jaw thrust. I-gel will be introduced in oral cavity with its concavity facing the mandible, then it will be pushed posteriorly while advancing along the hard palate, soft palate until a definitive resistance is felt. The device will be connected to the breathing circuit. Effective ventilation will be defined as the presence of square wave end tidal carbon dioxide waveform and simultaneous bilateral chest expansion. The following manoeuvres will be done in sequential manner to improve ventilation: 1. Chin lift 2. Jaw thrust 3. Head extension 4. Neck flexion 5. Gentle advancement 6. Withdrawal of I-gel will be done to improve ventilation. If the ventilation is not found to be effective even after the manoeuvres, the device shall be taken out and second attempt with a different size I-gel will be taken. The decision to increase or decrease the size of I-gel will be made by attending anaesthesiologist based on clinical judgement. When two attempts with the same technique fail, technique of other group will be used as a rescue technique with the initial I-gel size. Finally if third attempt fail, tracheal intubation shall be performed to secure the airway. After the completion of surgical procedure, standard reversal protocol of the institution shall be followed and patient will be reversed using neostigmine and glycopyrrolate and I- gel shall be removed and examined for presence of blood.
|
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Paediatric patients (7-12 years), ASA 1 and 2 under general anaesthesia. |
|
| ExclusionCriteria |
| Details |
Upper respiratory tract infection.
Increase risk of regurgitation.
Anticipated difficult airway.
Refusal to consent.
Emergency surgeries.
Surgeries planned under prone position. |
|
|
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 |
| To compare both the techniques in term of Mean insertion time. |
Insertion time will be calculated when the operator picks up the I-gel to the formation of square wave capnography on monitor. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Number of attempts
2. Ease of insertion
3. Ease of placement of nasogastric tube.
4. Postoperative complications like presence or absence of blood, sore throat, hoarseness. |
1. Till correct placement of I-gel with effective ventilation.
2. Till end of I-gel placement.
3. Till end of I-gel placement.
4. Presence or absence of blood on I-gel will be assessed at the end of extubation on I-gel, sore throat and hoarseness shall be examined at 2hr, 4hr, 6hr after extubation.
|
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/02/2024 |
| Date of Study Completion (India) |
25/09/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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 to compare triple airway manoeuvre and reverse insertion technique for I-gel placement in paediatric patients under general anaesthesia.The aim is to study both the techniques in term of mean insertion time, first attempt success rate, number of attempts required for successful placement, overall success rate, ease of insertion, ease of placement of nasogastric tube and postoperative complications. |