| CTRI Number |
CTRI/2025/08/093170 [Registered on: 18/08/2025] Trial Registered Prospectively |
| Last Modified On: |
14/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
"Which Breathing Tube Method Is Better for Adults Having Face Injury Surgery?" |
|
Scientific Title of Study
|
Prospective Comparison Of Retromolar And Submental Intubation Techniques In Maxillofacial Trauma Surgery Patients In The Age 18 Years And Above—A Randomized Clinical 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 Kainat Khan |
| Designation |
PhD Scholar |
| Affiliation |
Govt medical college and hospital, Nagpur |
| Address |
department of oral and maxillofacial surgery, first floor,room no 1, trauma care center, Govt medical college and hospital, medical square, Nagpur
Nagpur
MAHARASHTRA
-440003
India |
| Phone |
9284667685 |
| Fax |
|
| Email |
drkainatkhan01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kainat Khan |
| Designation |
PhD Scholar |
| Affiliation |
Govt medical college and hospital, Nagpur |
| Address |
department of oral and maxillofacial surgery, first floor, room no 1, trauma care center, Govt medical college and hospital, medical square, Nagpur
MAHARASHTRA
-440003
India |
| Phone |
9284667685 |
| Fax |
|
| Email |
drkainatkhan01@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kainat Khan |
| Designation |
PhD Scholar |
| Affiliation |
Govt medical college and hospital, Nagpur |
| Address |
department of oral and maxillofacial surgery, first floor, room no 1, trauma care center,Govt medical college and hospital, medical square, Nagpur
MAHARASHTRA
-440003
India |
| Phone |
9284667685 |
| Fax |
|
| Email |
drkainatkhan01@gmail.com |
|
|
Source of Monetary or Material Support
|
| department of oral and maxillofacial surgery, room no 1, first floor,trauma care center, Govt medical college and hospital, Nagpur-440003,Maharashtra,India |
|
|
Primary Sponsor
|
| Name |
Govt medical college and hospital Nagpur |
| Address |
department of oral and maxillofacial surgery, room no 1, first floor, trauma care centre, Govt medical college and hospital, medical square, Nagpur-440003, Maharashtra, India |
| 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 Kainat Khan |
Govt medical college and hospital |
department of oral and maxillofacial surgery, room:OT-A, first floor, trauma care centre, Govt medical college and hospital, Medical square,Nagpur-440003, Maharashtra, India
Nagpur
MAHARASHTRA |
9284667685
drkainatkhan01@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: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
retromolar intubation |
Intervention (Arm A):
Retromolar intubation – Patients will undergo endotracheal intubation via the retromolar route during maxillofacial trauma surgery.
|
| Comparator Agent |
submental intubation |
comparator (Arm B):
Submental intubation – Patients will undergo endotracheal intubation via the submental route during maxillofacial trauma surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
-Adults (typically aged 18 years and above).
-Diagnosed with panfacial/complex maxillofacial fractures requiring surgical repair.
-Patients with maxillofacial fractures contraindicated for nasotracheal intubation.
-Patients requiring management under general anesthesia.
-Willingness and ability to provide informed consent. |
|
| ExclusionCriteria |
| Details |
-Pediatric patients (under 18 years of age).
-Patients with severe comorbidities that may affect surgical outcomes or airway management decisions.
-Patients undergoing emergency procedures where immediate intubation methods (such as traditional oral intubation) are preferred.
-Patients who decline participation or are unable to provide informed consent. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assess visibility, accessibility, and maneuverability of the Surgical Field: To assess how each intubation technique affects the visibility, accessibility and maneuverability of the surgical field using following criteria.
|
at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Evaluate the Incidence of Complications: frequency and types of complications associated with each intubation technique, including tube bleeding, displacement, accidental extubation, infections, intraoperative tube injuries, kinking of the tube, need for third molar extraction, need for tube to be retained after surgery, salivary fistula, scarring and wound healing problems etc,
o Examine the Technical Difficulty: evaluate the technical challenges and ease of performing each intubation technique by assessing the skill required, the frequency of difficulties encountered, no. of attempts, need of assistance and the overall feasibility of each method |
o Assess the Duration of Intubation: the time required to perform successful intubation with each technique, including the time from initiation to completion of the intubation process in minutes. |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/09/2025 |
| 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="1"
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 - NO
|
|
Brief Summary
|
Effective airway management is crucial for patient safety during surgery The rationale for this study is to compare the outcomes of retromolar intubation and submental intubation in maxillofacial fracture patients for the purpose of identifying which technique offers superior results The study can contribute to evidencebased practices that enhance patient safety reduce the risk of airwayrelated complications and improve overall surgical success Although both retromolar and submental intubation techniques are used in practice there is extremely limited comprehensive research comparing them directly This study aims to fill that gap by providing a detailed comparison based on empirical data thus contributing to the body of knowledge and supporting the development of best practices in maxillofacial surgery |