| CTRI Number |
CTRI/2025/01/079510 [Registered on: 27/01/2025] Trial Registered Prospectively |
| Last Modified On: |
11/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Oral intubation success with endotracheal tube coiling |
|
Scientific Title of Study
|
The effect of preformed ‘O-shaped’ endotracheal tube on oral intubation success: A randomized 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 |
Aakriti Gupta |
| Designation |
Assistant Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research, Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care
PGIMER
Chandigarh
CHANDIGARH
160022
India |
| Phone |
08194800554 |
| Fax |
|
| Email |
aakriti1988.ag@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aakriti Gupta |
| Designation |
Assistant Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research, Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care
PGIMER
Chandigarh
CHANDIGARH
160022
India |
| Phone |
08194800554 |
| Fax |
|
| Email |
aakriti1988.ag@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aakriti Gupta |
| Designation |
Assistant Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research, Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care
PGIMER
Chandigarh
CHANDIGARH
160022
India |
| Phone |
08194800554 |
| Fax |
|
| Email |
aakriti1988.ag@gmail.com |
|
|
Source of Monetary or Material Support
|
| PGIMER, Chandigarh (160012), India |
|
|
Primary Sponsor
|
| Name |
PGIMER Chandigarh |
| Address |
Sector 12, Chandigarh (160012) |
| 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 |
| Aakriti Gupta |
Postgraduate Institute of Medical Education and Research, Chandigarh |
Department of Anaesthesia and Intensive Care, 4th floor, Nehru Hospital
Chandigarh
CHANDIGARH |
08194800554
aakriti1988.ag@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Intramural) |
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 |
Group C |
The investigator will use a conventional-shaped endotracheal tube without any stylet. |
| Intervention |
Group O |
The investigator will bend the ETT in the shape of an "O" by exaggerating the pre-existing Magill curve of the ETT. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status I and II patients scheduled to undergo elective surgery under general anaesthesia |
|
| ExclusionCriteria |
| Details |
1. ASA III and IV patients
2. Anticipated/unanticipated (Cormack and Lehane grade 3 and 4) difficult airway
3. Patients with oropharyngeal mass/tumour
4. Craniofacial surgery
5. Emergency surgery
• Patients requiring nasal intubation
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time to successful intubation |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a) first-attempt intubation success rate
b) ease of intubation on a Visual Analog Scale (VAS)
c) adverse events |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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)
|
05/02/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
Modification(s)
|
There are cases in which an endotracheal tube cannot be successfully advanced into the trachea, but intubation aids like bougie and stylet may not be available and also have problems associated with their use. So, we intend to study the effect of endotracheal tube coiling in the shape of an ’O’ before intubation on intubation success and ease. |