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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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  

Airway management of patients with maxillofacial trauma poses serious challenges due to disarranged anatomy as well as associated injuries, haemorrhage, and edema, with almost 24-30% incidence of difficult laryngoscopy and/or intubation. Therefore, accurately predicting challenging laryngoscopy is vital to reduce adverse outcomes and improve patient safety.

Traditional airway assessment methods—such as measuring inter-incisor and thyromental distances, using the modified Mallampati Score, evaluating neck mobility, and performing the upper lip bite test—are often unreliable, demonstrating poor predictive power, sensitivity, and specificity. These bedside evaluations may be impractical in patients with facial maxillary injuries (FMI) due to their altered external anatomy, swelling, blood or secretions, extreme pain, and sometimes cervical spine injuries.

As a result, there is an urgent need for objective predictors of difficult laryngoscopy. Previous studies have shown that radiological assessments, particularly sonography and CT imaging, are invaluable for airway evaluation. However, ultrasound can be challenging and uncomfortable for patients due to local edema. We propose that CT-guided parameters, including both airway characteristics and fracture types, can reliably predict difficult laryngoscopy in individuals with faciomaxillary trauma. Hence we have planned this study with the aim of determining radiological (CT imaging) predictors, including both airway parameters as well as type of fractures, of difficult laryngoscopy in patients with faciomaxillary injury.

 
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