| CTRI Number |
CTRI/2025/10/095623 [Registered on: 06/10/2025] Trial Registered Prospectively |
| Last Modified On: |
05/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of head positions for flexible camera guiding nasal tube in patients with difficulty in putting tube |
|
Scientific Title of Study
|
Comparison of head positions (Sniffing vs Extension) for awake flexible bronchoscope guided nasotracheal intubation in patients with difficult airway: 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 Rohithkrishna B |
| Designation |
Junior resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
17,2-M,GRN FLATS,2ND MAIN ROAD,NANGANALLUR,CHENNAI-61
Chennai
TAMIL NADU
600061
India |
| Phone |
7094748494 |
| Fax |
|
| Email |
drtnbrk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rohithkrishna B |
| Designation |
Junior resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
17,2-M,GRN FLATS,2ND MAIN ROAD,NANGANALLUR,CHENNAI-61
Chennai
TAMIL NADU
600061
India |
| Phone |
7094748494 |
| Fax |
|
| Email |
drtnbrk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rohithkrishna B |
| Designation |
Junior resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
17,2-M,GRN FLATS,2ND MAIN ROAD,NANGANALLUR,CHENNAI-61
Chennai
TAMIL NADU
600061
India |
| Phone |
7094748494 |
| Fax |
|
| Email |
drtnbrk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute intramural fund- JIPMER Intramural fund |
|
|
Primary Sponsor
|
| Name |
JIPMER |
| Address |
JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, 605006 |
| 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 |
| Dr Satyaprakash MVS |
JIPMER |
JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, 605006
Pondicherry
PONDICHERRY |
97861 84626
munaganuri1975@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee-IEC JIPMER |
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 |
Extension head position(EP GROUP) in awake flexible bronchoscope |
Putting the head in extension position
By adjusting certain maneuvers |
| Comparator Agent |
Sniffing position (SP GROUP) |
Sniffing position as conventional head position used in flexible bronchoscope guuded intubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Adult patients aged 18-65 years uundergoing elective surgeries.
2.
2.American Society of Anesthesiologists (ASA) status 1, 2 and 3 requiring awake Flexible bronchoscope guided nasotracheal intubation for airway management during anesthesia administration
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time to view the vocal cords |
Time to view the vocal cords |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To evaluate and compare Time taken for viewing the tracheal rings (TVTR) between ‘Group SP’ and ‘Group EP’ |
|
To evaluate and compare Time taken for successful endotracheal tube placement (TETP) between ‘Group SP’ and ‘Group EP’
|
|
To compare Number of Attempts between ‘Group SP’ and ‘Group EP’
|
|
To compare Ease of intubation between ‘Group SP’ and ‘Group EP’
|
|
To evaluate and compare Hemodynamic alterations of the patients during intubation between ‘Group SP’ and ‘Group EP’
|
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
27/10/2025 |
| 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="2"
Months="0"
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
|
Awake fiberoptic bronchoscope oral intubation (AFOI) is widely regarded as the gold standard for airway management in patients with difficult airways. Various factors influence the success of this technique, including sedation methods, airway anatomy, and head positioning Management of the difficult airway has been a critical topic in anesthesiology for decades. Difficult airway incidences range from 0.3% to 13%, and nearly 30% of anesthesia-related mortalities are directly linked to airway complications. (2) Thus, awake fiberoptic bronchoscope (FOB) intubation has emerged as the gold standard for securing airways in patients with anticipated difficulties. |