| CTRI Number |
CTRI/2025/11/097135 [Registered on: 10/11/2025] Trial Registered Prospectively |
| Last Modified On: |
07/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of conventional technique versus modified tube first technique of awake nasotracheal fiberoptic intubation |
|
Scientific Title of Study
|
A Randomized comparative study between the modified tube first technique and conventional technique for awake nasal fiberoptic intubation in patients with anticipated difficult airways |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| vijayshreejangid5@gmail.com |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajni Mathur |
| Designation |
Senior professor |
| Affiliation |
Department of anaesthesia, SMS medical college and attached hospital Jaipur |
| Address |
Department of anaesthesia, SMS medical college and attached hospital Jaipur
Jhunjhunun
RAJASTHAN
302004
India |
| Phone |
9829357194 |
| Fax |
|
| Email |
rajnimathur@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajni Mathur |
| Designation |
Senior professor |
| Affiliation |
Department of anaesthesia, SMS medical college and attached hospital Jaipur |
| Address |
Department of anaesthesia, SMS medical college and attached hospital Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9829357194 |
| Fax |
|
| Email |
Rajnimathur@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vijayshri Priyanka |
| Designation |
Anaesthesia resident |
| Affiliation |
Department of anaesthesia, SMS medical college and attached hospital Jaipur |
| Address |
Department of anaesthesia, SMS medical college and attached hospital Jaipur
Jhunjhunun
RAJASTHAN
302004
India |
| Phone |
7726932950 |
| Fax |
|
| Email |
vijayshreejangid5@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sawai Mansingh medical college and attached hospital Jaipur |
| Address |
Sawai Mansingh medical college and attached hospital Jaipur |
| 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 Vijayshri Priyanka |
Sawai Mansingh medical college and attached hospital Jaipur |
Plastic operation theatre 2nd floor Dhanvanthri block SMS medical college Jaipur
Jhunjhunun
RAJASTHAN |
7726932950
vijayshreejangid5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of Ethics committee SMS medical college and attached hospital Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M26-M27||Dentofacial anomalies [including malocclusion] and other disorders of jaw, (2) ICD-10 Condition: M266||Temporomandibular joint disorders, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional technique in awake nasotracheal fibre optic nasal intubation |
To assess and compare the procedural time required for awake nasal fibre optic intubation between the modified tube first technique versus conventional technique |
| Comparator Agent |
Modified tube first technique of awake nasotracheal fibre optic intubation |
To assess and compare the procedural time required for awake nasal fibre optic intubation between the modified tube first technique versus conventional technique |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients undergoing oral maxillofacial surgery with anticipated difficult intubation.
2. Patients of either sex aged between 18 -55 years.
3. American Society of Anesthesiologists (ASA) physical status classes I and II.
4. Anticipated difficult airway, defined as Mallampati grade (MMG). 5. Scheduled for elective surgery.
6. Willing to provide written informed consen |
|
| ExclusionCriteria |
| Details |
1.Refusal to provide written informed consent.
2. Patient’s Presence of nasal mass.
3. Bleeding disorders.
4. Base of skull fracture.
5. History of nasopharyngeal surgery. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean time taken from the insertion of the fibre optic bronchoscope or endotracheal tube to the successful placement and inflation of the cuff in the trachea |
Mean time taken from the insertion of the fibre optic bronchoscope or endotracheal tube to the successful placement and inflation of the cuff in the trachea |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mean number of attempts
Ease of device placement
Complications if any
Mean patient reaction scores |
Mean time taken (in sec)from the insertion of the fibre optic bronchoscope or endotracheal tube to the successful placement & inflation of the cuff in the trachea |
|
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Target Sample Size
|
Total Sample Size="94"
Sample Size from India="94"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
24/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
24/11/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
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
|
This study is a prospective, randomised open label trail conducted on 94 patients with an anticipated difficult airway undergoing oromaxillofacial surgery. The patients were randomised into modified tube first MTF group (47)and conventional technique group(47). Times from insertion of the fibre optic scope into nares till vocal cord visualisation T1 and from T1 to complete intubation T2 were measured and compared.our study shows that MTF is better than conventional technique for awake nasotracheal intubation, requiring lesser time and attempts while maintaining airway patently |