| CTRI Number |
CTRI/2024/01/061579 [Registered on: 18/01/2024] Trial Registered Prospectively |
| Last Modified On: |
16/01/2024 |
| 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 giving oxygen to the lungs in patients with face injuries |
|
Scientific Title of Study
|
A Prospective Randomized Comparison Of Videolaryngoscopy Alone With Videolaryngoscope-assisted fibreoptic Intubation In Anticipated Difficult Airways Of Maxillofacial Trauma |
| 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 Kajal Jain |
| Designation |
Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
Department of Anaesthesia and Intensive Care
Postgraduate Institute of Medical Education and Research, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
|
| Fax |
|
| Email |
kajalteji@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nidhi Bhatia |
| Designation |
professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
Department of Anaesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9914207483 |
| Fax |
|
| Email |
nidhi.bhatia75@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nidhi Bhatia |
| Designation |
professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
Department of Anaesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9914207483 |
| Fax |
|
| Email |
nidhi.bhatia75@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia and Intensive Care, PGIMER, Chandigarh |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesia and Intensive Care |
| Address |
Sector 12, PGIMER, Chandigarh |
| 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 Nidhi Bhatia |
Postgraduate Institute of Medical Education and Research |
Department of Anaesthesia and Intensive Care, Nehru Hospital, Sector 12, Postgraduate Institute of Medical Education and Research, Chandigarh
Chandigarh
CHANDIGARH |
9914207483
nidhi.bhatia75@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S02||Fracture of skull and facial bones, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
-videolaryngoscope guided intubation |
ETT will be inserted blindly through the nostril selected (as per the pre-anesthetic evaluation), with the tip directed along the floor of the nose. If resistance is encountered, the tube will be redirected slightly caudally. If the resistance persists, ETT will be redirected slightly cephalad. Resistance offered to the passage of ETT will be graded as slight, moderate or obstructed. If obstruction is encountered, the ETT will be inserted through the other nostril. Once the ETT crosses the nasopharynx, it will be directed through the glottis using VLS, with/without the aid of magill forceps. |
| Intervention |
Videolaryngoscoe assisted fibreoptic intubation |
an ETT will be loaded on the fibrescope and fibreoptic examination of both nostrils will be performed, by passing the fiberscope below and above the inferior turbinate. The most patent nostril will be selected and used for intubation. One the fibrescope crosses the nasopharynx, a second assistant will perform VLS to get the best possible glottic view and a fibrescope preloaded with ETT will be introduced to intubate the trachea. The duration of intervention will be the time taken for anesthesia induction |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
patients with maxillofacial trauma, scheduled for fracture fixation under general anaesthesia (GA) and requiring nasotracheal intubation |
|
| ExclusionCriteria |
| Details |
patients with history of nasal obstruction or previous nasal surgery, history of nasal disease, including epistaxis, history of known coagulation abnormalities, morbid obesity, and patients who refuse consent |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| First pass intubation success rate |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Incidence of epistaxis through the nostril
2. Severity of bleeding through the nostril
3. Ease of passing tube through the nostril
4. Time of successful intubation
5. Number of intubation attempts
6. Patency of the nostril following extubation
|
Baseline |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
25/01/2024 |
| Date of Study Completion (India) |
31/01/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Airway management of patients with maxillofacial trauma is challenging due to the presence of injury, edema, distorted facial anatomy and associated bleeding. Previous literature is sparse with regards to the use of video-assisted fiberoptic intubation (VAFI) in difficult airways, with most of the prior studies that compare VAFI with videolaryngoscope, being either inconclusive or having been done on a cadaver model and not a real patient. We have thus planned this study with the aim of comparing the VAFI technique with standard videolaryngoscopy for securing the nasotracheal tube in patients with anticipated difficult airways following maxillofacial trauma. We hypothesize that VAFI will aid in increasing the first-attempt intubation success rate as well as decrease the risk of nasal bleeding in patients with maxillofacial trauma requiring nasotracheal intubation |