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CTRI Number  CTRI/2025/03/083470 [Registered on: 26/03/2025] Trial Registered Prospectively
Last Modified On: 04/05/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Clinical decision making in difficult airway management in head and neck surgery. 
Scientific Title of Study   Incidence,risk factors and outcomes for anticipated difficult airway management in head and neck surgery. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sheeba franklin 
Designation  Additional professor, department of anesthesiology, Government medical college, Kottayam  
Affiliation  Government Medical College Kottayam 
Address  Njondimackal,thellakom.p.o,kottayam, Njondimackal,thellakom.p.o,kottayam, kerala
Njondimackal,thellakom.p.o,kottayam, Njondimackal,thellakom.p.o,kottayam, kerala
Kottayam
KERALA
686630
India 
Phone  9447315132  
Fax    
Email  sheebabinu04@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sheeba franklin 
Designation  Additional professor, department of anesthesiology, Govt medical college, Kottayam  
Affiliation  Government Medical College Kottayam 
Address  Njondimackal,thellakom.p.o,kottayam, Njondimackal,thellakom.p.o,kottayam, kerala
Njondimackal,thellakom.p.o,kottayam, Njondimackal,thellakom.p.o,kottayam, kerala
Kottayam
KERALA
686630
India 
Phone  9447315132  
Fax    
Email  sheebabinu04@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sheeba franklin 
Designation  Additional professor, department of anesthesiology, Government medical college, Kottayam  
Affiliation  Government Medical College Kottayam 
Address  Njondimackal,thellakom.p.o,kottayam, Njondimackal,thellakom.p.o,kottayam, kerala
Njondimackal,thellakom.p.o,kottayam, Njondimackal,thellakom.p.o,kottayam, kerala
Kottayam
KERALA
686630
India 
Phone  9447315132  
Fax    
Email  sheebabinu04@gmail.com  
 
Source of Monetary or Material Support  
SBMR, Government medical College, Kottayam  
 
Primary Sponsor  
Name  Government medical College  
Address  Department of anesthesia,Government medical college, Kottayam. 
Type of Sponsor  Government medical college 
 
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 
Sheeba franklin  Government medical college,kottayam  Department of anesthesia, Government medical College, Kottayam
Kottayam
KERALA 		 09447315132

sheebabinu04@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional review board  Approved 
 
Regulatory Clearance Status from DCGI
Modification(s)  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Incidence, risk factors, outcomes.  Patients of either sex, scheduled for head and neck surgical procedures under general anesthesia at Government Medical College, Kottayam during 2023-2026.  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patients of either sex, scheduled for head and neck surgical procedures under general anesthesia at
Government Medical College, Kottayam during 2023-2026. 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Indications of head and neck surgery where there is threatening of airway perioperatively  Indications of major head and neck surgery where there is threatening of airway perioperatively 1 year.till sample size attained 
 
Secondary Outcome  
Outcome  TimePoints 
1.
Number of intubation attempts required 2. Type of airway device used. 3. Airway symptoms or parameters suggestive of difficult airway.3.airway device used.
Lowest oxygen saturation or any complications during intubation attempts. 		 Perioperatively ,1 year, till sample size attained  
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="500" 
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   N/A 
Date of First Enrollment (India)   07/04/2025 
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="1"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sheebabinu04@gmail.com].

  6. For how long will this data be available start date provided 01-04-2025 and end date provided 01-03-2025?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Improved outcomes in head and neck surgical patients can be achieved by identifying the predictors of first intubation plan and choosing safer options of airway management. 
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