| CTRI Number |
CTRI/2026/01/101945 [Registered on: 23/01/2026] Trial Registered Prospectively |
| Last Modified On: |
22/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing two methods of placing a breathing tube in awake patients with difficult airways |
|
Scientific Title of Study
|
A comparative study between conventional technique and tube first technique in awake nasotracheal fiberoptic intubation in difficult airway management |
| 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 SHOAIB AHMAD |
| Designation |
PG Resident |
| Affiliation |
Career Institute Of Medical Sciences And Hospital Lucknow |
| Address |
Department Of Anesthesiology Career Institute Of Medical Sciences And Hospital Lucknow IIM Road Ghaila Lucknow
Lucknow
UTTAR PRADESH
226013
India |
| Phone |
9044465003 |
| Fax |
|
| Email |
shoaibkhan78600@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR PRIYESH BHASKAR |
| Designation |
Professor And Head Of Department Of Anesthesiology |
| Affiliation |
Career Institute Of Medical Sciences And Hospital Lucknow |
| Address |
Department Of Anesthesiology, Operation Theatre Complex, Career Institute Of Medical Sciences And Hospital Lucknow
Lucknow
UTTAR PRADESH
226013
India |
| Phone |
7985975077 |
| Fax |
|
| Email |
drpriyeshlpsc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR PRIYESH BHASKAR |
| Designation |
Professor And Head Of Department Of Anesthesiology |
| Affiliation |
Career Institute Of Medical Sciences And Hospital Lucknow |
| Address |
Department Of Anesthesiology, Operation Theatre Complex, Career Institute Of Medical Sciences And Hospital Lucknow
UTTAR PRADESH
226013
India |
| Phone |
7985975077 |
| Fax |
|
| Email |
drpriyeshlpsc@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Career Institute Of Medical Sciences And Hospital Lucknow |
| Address |
Career Institute Of Medical Sciences And Hospital IIM Road Ghaila Lucknow |
| Type of Sponsor |
Private 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 Shoaib Ahmad |
Career Institute Of Medical Sciences And Hospital |
Resident room no 1 Division 1 Department Of Anesthesiology Operation Theatre Complex
Lucknow
UTTAR PRADESH |
9044465003
shoaibkhan78600@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Career Institute Of Medical Sciences And Hospital Lucknow |
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 |
Conventional technique |
Awake nasotracheal fibreoptic intubation using conventional technique |
| Intervention |
Tube first technique |
Awake nasotracheal fibreoptic intubation using tube first technique
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients aged eighteen to sixty five years with anticipated difficult airway scheduled for elective surgery under general anaesthesia requiring awake nasotracheal fibreoptic intubation. Patients belonging to American Society of Anesthesiologists physical status class one and two. Patients able to cooperate for awake procedure and willing to provide written informed consent |
|
| ExclusionCriteria |
| Details |
Patients refusing consent. Emergency surgeries. Uncooperative patients. Patients with severe cardiorespiratory disease. Patients with active upper airway pathology such as tumours, infection or bleeding. Patients with bleeding diathesis or on anticoagulant therapy. Patients with gross facial deformity, unstable cervical spine or nasal obstruction precluding nasotracheal intubation. Pregnant patients. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total intubation time in conventional technique versus tube first technique during awake nasotracheal fiberoptic intubation |
From insertion of fiberoptic bronchoscope to confirmation of endotracheal tube placement |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Ease of glottic visualization during awake fibreoptic intubation |
During advancement of fibreoptic bronchoscope |
| Number of attempts required for successful intubation |
During awake nasotracheal fibreoptic intubation |
| Procedure related complications such as desaturation, bleeding, coughing or failure of technique |
During and immediately after awake nasotracheal fibreoptic intubation |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
05/02/2026 |
| 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="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
|
This is a prospective interventional study comparing the conventional technique and the tube-first technique in awake nasotracheal fibreoptic intubation in patients with anticipated difficult airway. Adult patients scheduled for elective surgery requiring awake nasotracheal fibreoptic intubation will be enrolled. Participants will be allocated to either the conventional technique group or the tube-first technique group. The primary outcome will be the success of intubation and time taken for successful awake nasotracheal fibreoptic intubation. Secondary outcomes will include ease of glottic visualization, number of attempts required for successful intubation, and procedure-related complications such as desaturation, bleeding, coughing, or failure of technique. The study aims to determine the safer and more effective technique for awake fibreoptic intubation in difficult airway management. |