| CTRI Number |
CTRI/2026/02/102771 [Registered on: 02/02/2026] Trial Registered Prospectively |
| Last Modified On: |
02/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing two ways of holding the breathing tube in patients undergoing surgery to see which makes tube placement easier and faster. |
|
Scientific Title of Study
|
Comparison of holding of Endotracheal Tube during Direct Laryngoscopy to identify the optimum holding site for intubation. 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 |
Dr Sumeet Chugh |
| Designation |
SAG/Professor |
| Affiliation |
Dr BSA Medical college and Hospital |
| Address |
E-13 New Multan Nagar
New Delhi Department Of Anaesthesiology and intensive Care
Sector VI
Rohini
New delhi-110085 North West DELHI 110056 India |
| Phone |
09873753429 |
| Fax |
|
| Email |
drsumeetchugh@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sumeet Chugh |
| Designation |
SAG/Professor |
| Affiliation |
Dr BSA Medical college and Hospital |
| Address |
E-13 New Multan Nagar
New Delhi Department Of Anaesthesiology and intensive Care
Sector VI
Rohini
New delhi-110085 North West DELHI 110056 India |
| Phone |
09873753429 |
| Fax |
|
| Email |
drsumeetchugh@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sumeet Chugh |
| Designation |
SAG/Professor |
| Affiliation |
Dr BSA Medical college and Hospital |
| Address |
E-13 New Multan Nagar
New Delhi Department Of Anaesthesiology and intensive Care
Sector VI
Rohini
New delhi-110085 North West DELHI 110056 India |
| Phone |
09873753429 |
| Fax |
|
| Email |
drsumeetchugh@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DR BSA Medical college and Hospital |
| Address |
Sector VI
Rohini
New Delhi-110085 |
| 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 Sumeet Chugh |
Dr. Baba Saheb Ambedkar Medical College and Hospital , Department of Anaesthesiology |
Department of Anaesthesiology,
Dr. Baba Saheb Ambedkar Medical College and Hospital,
Sector-6, Rohini, New Delhi – 110085, India North West DELHI |
09873753429
drsumeetchugh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr Baba Saheb Ambedkar Medical College and Hospital Govt of NCT of Delhi Sector VI Rohini Delhi 110085 Institutional Ethics Committee Reg No EC/New/Inst/2025/DL/0666 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ETT held at 18 cm from tip |
Participants will be randomly allocated to one of two groups. In Group A, the anesthesiologist will hold the endotracheal tube at the 18 cm mark from the distal tip during direct laryngoscopy. In Group B, the anesthesiologist will hold the endotracheal tube at 26 cm mark from the distal tip. All patients will undergo standardized induction of general anesthesia and tracheal intubation using a Macintosh laryngoscope and appropriately sized endotracheal tubes. Intubations will be performed by trainee anesthesiologists under supervision. All other aspects of airway management and anesthesia technique will be standardized. The intervention is a one-time intraoperative manoeuvre. The total duration of the intervention is from insertion of the endotracheal tube into the mouth until successful intubation confirmed by capnography approximately 10–30 seconds |
| Comparator Agent |
ETT held at 26 cm from tip |
Participants will be randomly allocated to one of two groups. In Group A, the anesthesiologist will hold the endotracheal tube at the 18 cm mark from the distal tip during direct laryngoscopy. In Group B, the anesthesiologist will hold the endotracheal tube at the 26 cm mark from the distal tip. All patients will undergo standardized induction of general anesthesia and tracheal intubation using a Macintosh laryngoscope and appropriately sized endotracheal tubes. Intubations will be performed by trainee anesthesiologists under supervision. It will be a single intraoperative intervention lasting until successful intubation (approximately 10–30 seconds).”
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients aged 18 to 65 years, of either sex, scheduled for elective surgery under general anaesthesia requiring endotracheal intubation, with American Society of Anesthesiologists (ASA) physical status I or II, Mallampati airway classification I or II, adequate mouth opening greater than 3 cm, normal neck mobility, and body mass index (BMI) less than 35 kg/m² will be included in the study. |
|
| ExclusionCriteria |
| Details |
Patients with an anticipated difficult airway, those undergoing emergency or obstetric procedures, patients with severe systemic disease (ASA physical status III or above), and those with active upper airway pathology or infection will be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TIME TO SUCCESSFUL INTUBATION |
Baseline, During Induction Intraoperative.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Intubation Difficulty Scale
First pass success rate
Ease of intubation
Haemodynamic Response
Airway complications
|
Haemodynamic response 1 3 and 5 minutes post intubation
Complications after 1 hour and 24 hours post operative
Maximum 3 attempts
|
|
|
Target Sample Size
|
Total Sample Size="430" Sample Size from India="430"
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)
|
15/02/2026 |
| 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="6" 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response (Others) - For secondary analyses related to airway management and intubation performance.
- By what mechanism will data be made available?
Response (Others) - By contacting the principal investigator after publication
- For how long will this data be available start date provided 30-11-2026 and end date provided 29-11-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This randomised interventional study aims to compare two different holding positions of the endotracheal tube(18cm versus 26 cm from the tip)during direct laryngoscopy for tracheal intubation in adult patients undergoing elective surgery under general anaesthesia. Participants will be randomly allocated to either group. The primary outcome is time to successful intubation, measured from the insertion of the laryngoscope to the appearance of a sustained end tidal carbon dioxide waveform. Secondary outcomes include intubation difficulty score, first pass success rate, number of optimisation manouvers, Cormack Lehane grade and airway related complications. The study seeks to identify whether tube holding position influences ease and efficiency of tracheal intubation. |