| CTRI Number |
CTRI/2025/04/085633 [Registered on: 25/04/2025] Trial Registered Prospectively |
| Last Modified On: |
24/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Comparing two different ways for
introducing tube into airway |
|
Scientific Title of Study
|
Efficacy of orotracheal intubation using stylet versus between-the-finger grip for holding endotracheal tube: A Prospective randomized study |
| 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 Nadia Rose |
| Designation |
Associate Professor |
| Affiliation |
Dr Nadia Rose |
| Address |
Department of Anaesthesiology, Rajarajeswari medical college and Hospital, Bangalore
Bangalore
KARNATAKA
560074
India |
| Phone |
09513454567 |
| Fax |
|
| Email |
dr.nadia.rose@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nadia Rose |
| Designation |
Associate Professor |
| Affiliation |
Dr Nadia Rose |
| Address |
Department of Anaesthesiology, Rajarajeswari medical college and Hospital, Bangalore
KARNATAKA
560074
India |
| Phone |
09513454567 |
| Fax |
|
| Email |
dr.nadia.rose@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nadia Rose |
| Designation |
Associate Professor |
| Affiliation |
Dr Nadia Rose |
| Address |
Department of Anaesthesiology, Rajarajeswari medical college and Hospital, Bangalore
KARNATAKA
560074
India |
| Phone |
09513454567 |
| Fax |
|
| Email |
dr.nadia.rose@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajarajeswari medical college and hospital, mysore road, bangalore-560074 |
|
|
Primary Sponsor
|
| Name |
Dr Nadia Rose |
| Address |
Department of Anaesthesiology,Rajarajeswari medical college and hospital,mysore road,Bangalore-560074,karnataka |
| Type of Sponsor |
Other [self] |
|
|
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 Nadia Rose |
Rajarajeswari Medical college and hospital. |
Ot complex,Department of Anaesthesiology,
Rajarajeswari medical college and Hospital,Bangalore-560074
Bangalore
KARNATAKA |
09513454567
dr.nadia.rose@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rajarajeswari medical college and hospital instituitional ethics committe |
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 |
| Comparator Agent |
Between-the -finger grip |
Using modified way of holding the endotracheal tube |
| Intervention |
Endotracheal tube with stylet |
Using stylet for endotracheal intubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All ASA 1 and 2 patients between 18-60 years posted for elective surgeries under general anaesthesia with orotracheal intubation with PVC endotracheal tube. |
|
| ExclusionCriteria |
| Details |
Patient refusal, ASA 3 and above ,Mallamapti 3 and 4, anticipated difficult airway, Cormack Lehane grading 3b and 4,pregnancy,coagulopathy or history of anticoagulant use
|
|
|
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 successful intubation on the first attempt between the endotracheal tube with stylet versus tube between –the -finger grip groups. |
At time of intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the need of BURP ( backward, upward, rightward pressure) maneuver and number of attempts at intubation between use of stylet and between- the- finger grip for orotracheal intubation.
|
At time of intubation |
|
|
Target Sample Size
|
Total Sample Size="210"
Sample Size from India="210"
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
|
N/A |
|
Date of First Enrollment (India)
|
12/05/2025 |
| 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="0"
Months="5"
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
|
Tracheal intubation is a routinely done procedure in general anesthesia. Polyvinylchloride tubes (PVC)are most commonly used tubes for intubation. Although there are several methods of tracheal intubation described , there are not many studies comparing different grips for holding the PVC endotracheal tube during the process of intubation. Recently BETI trail compared the conventional grip to a modified grip where in the fulcrum being the ring finger. In this study we primarily aim to compare the success of first time intubation between the endotracheal tube with stylet and tube between finger grip for intubation. There are not many studies comparing the modified in- between –finger grips versus stylet for endotracheal intubation. Hence we are doing this study Group F (between the fingers) and Group N (Hockey shape with stylet).Participants will be blinded to their study group. Endotracheal intubation will be attempted in the sniffing position by an experienced anaesthesiologist. The endotracheal intubation will be done as per group allocation. The between-the finger grip will use middle finger as the fulcrum. |