| CTRI Number |
CTRI/2024/11/077012 [Registered on: 19/11/2024] Trial Registered Prospectively |
| Last Modified On: |
16/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
prospective, observational |
| Study Design |
Other |
|
Public Title of Study
|
Predicting difficulty in securing the airway on CT in patients with facial injuries |
|
Scientific Title of Study
|
Predictors of Difficult Laryngoscopy on Computed Tomography in Patients with Faciomaxillary Injury - A Prospective, Observational Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Raavi Rishitha |
| Designation |
Junior Resident |
| Affiliation |
PGIMER |
| Address |
Dept of Anaesthesia
Anaesthesia office,
Level 4, Nehru hospital,
Sector 12,
PGIMER, Chandigarh
Chandigarh CHANDIGARH 160012 India |
| Phone |
9894324462 |
| Fax |
|
| Email |
raavirishitha99@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Nidhi Bhatia |
| Designation |
professor |
| Affiliation |
PGIMER |
| Address |
Department of Anaesthesia and Intensive Care, PGIMER, Sector 12, Chandigarh
Chandigarh CHANDIGARH 160012 India |
| Phone |
09914207483 |
| Fax |
|
| Email |
nidhi.bhatia75@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Nidhi Bhatia |
| Designation |
professor |
| Affiliation |
PGIMER |
| Address |
Department of Anaesthesia and Intensive Care, PGIMER, Sector 12, Chandigarh
Chandigarh CHANDIGARH 160012 India |
| Phone |
09914207483 |
| Fax |
|
| Email |
nidhi.bhatia75@gmail.com |
|
|
Source of Monetary or Material Support
|
| Postgraduate Institute of Medical Education & Research,
Sector 12,
Chandigarh
160012
India |
|
|
Primary Sponsor
|
| Name |
Raavi Rishitha |
| Address |
Dept of Anaesthesia and Intensive Care,
Anaesthesia office,
Level 4,
Nehru hospital,
Sector 12,
PGIMER, Chandigarh
160012,
India |
| Type of Sponsor |
Other [Self] |
|
|
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 Raavi Rishitha |
PostGraduate Institute of Medical Education and Research, Chandigarh |
Level 3, Trauma OT,
Advanced Trauma Centre,
Dept of Trauma Anaesthesia,
Sector12,
160012, Chandigarh,
India
Chandigarh CHANDIGARH |
9894324462
raavirishitha99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Intramural, PostGraduate Institute of Medical Education & Research, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S024||Fracture of malar, maxillary and zygoma bones, (2) ICD-10 Condition: S026||Fracture of mandible, (3) ICD-10 Condition: S022||Fracture of nasal bones, (4) ICD-10 Condition: S023||Fracture of orbital floor, (5) ICD-10 Condition: S028||Fractures of other specified skulland facial bones, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologists (ASA) physical status I-II patients, in the age group of 18-65 years, with Lefort type I/II/III Fracture / Bilateral mandibular / parasymphysis menti fracture / Displaced coronoid / condyloid fracture scheduled to undergo maxillofacial injury fixation under general anaesthesia will be enrolled in the study. |
|
| ExclusionCriteria |
| Details |
1. Isolated zygoma fractures
2. Isolated nasal bone fractures
3. History of surgery/burns/radiotherapy of the head and neck region
4. Tracheostomised patients
5. Refusal to give consent for the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine CT guided predictors of difficult laryngoscopy in faciomaxillary trauma patients. |
At baseline (time of endotracheal intubation) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine the best model fit predictors of difficult laryngoscopy using stepwise logistic regression.
|
At baseline (at the time of endotracheal intubation) |
| Incidence of difficult laryngoscopy in faciomaxillary trauma patients. |
At baseline (at the time of endotracheal intubation) |
| First pass intubation success rate |
At baseline (at the time of endotracheal intubation) |
|
|
Target Sample Size
|
Total Sample Size="180" Sample Size from India="180"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="188" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/12/2024 |
| Date of Study Completion (India) |
Date Missing |
| 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
|
|