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CTRI Number  CTRI/2024/10/074634 [Registered on: 03/10/2024] Trial Registered Prospectively
Last Modified On: 28/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Diagnostic 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study to predict difficult airway and breathing methods 
Scientific Title of Study   Ratio of neck circumference-TMD and height-TMD as a predictor of anticipated difficult tracheal intubation 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sapna Bansal 
Designation  HOD Professor 
Affiliation  MM Institute of Medical Sciences and Research Centre  
Address  Dept. Of Anaesthesiology MM Institute of Medical Sciences and Research Centre Mullana Ambala Haryana

Ambala
HARYANA
133207
India 
Phone  8168381441  
Fax    
Email  drsapna10@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sapna Bansal 
Designation  HOD Professor 
Affiliation  MM Institute of Medical Sciences and Research Centre  
Address  Dept. Of Anaesthesiology MM Institute of Medical Sciences and Research Centre, Mullana Ambala Haryana

Ambala
HARYANA
133207
India 
Phone  8168381441  
Fax    
Email  drsapna10@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sapna Bansal 
Designation  HOD Professor 
Affiliation  MM Institute of Medical Sciences and Research Centre  
Address  Dept. Of Anaesthesiology MM Institute of Medical Sciences and Research Centre Mullana Ambala Haryana

Ambala
HARYANA
133207
India 
Phone  8168381441  
Fax    
Email  drsapna10@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, MM Institute of Medical Sciences and Research Centre,mullana, Ambala, Haryana, 133207, India 
 
Primary Sponsor  
Name  Department of Anaesthesiology  
Address  MM Institute of Medical Sciences and Research Centre,mullana, Ambala, Haryana, 133207, India 
Type of Sponsor  Private 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 
Vedika Marodia  MM institute of medical sciences and research  Department of Anaesthesiology, 2nd floor old building, MMIMSR, mullana Ambala
Ambala
HARYANA 		 8178932289

vmarodia.vm@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee,MMIMSR,Mullana,Ambala  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Patient planned for elective surgeries under General Anaesthesia 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Comparison of height - TMD for difficult intubation   To compare the height-TMD as a predictor of difficult tracheal intubation 
Comparator Agent  Comparison of neck circumference-TMD for difficult intubation  To compare the Neck circumference-TMD as a predictor of difficult tracheal intubation  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  ASA 1,2
Patient who gave written informed consent
Age between 18 to 80years
Elective surgery 
 
ExclusionCriteria 
Details  ASA 3,4
Patient refusal
Emergency cases 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the ratio of NC/TMD and Height/TMD  Perioperative period 
 
Secondary Outcome  
Outcome  TimePoints 
To calculate the IDS (Intubation Difficulty Score) during intubation
To compare the NC/TMD and Height/TMD as a predictor of difficult tracheal intubation 		 Perioperative periods  
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   09/10/2024 
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="0"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

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

  3. Who will be able to view these files?
    Response - Anyone

  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 [vmarodia.vm@gmail.com].

  6. For how long will this data be available start date provided 05-08-2024 and end date provided 10-03-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   Management of airway is one of the major responsibilities of an anaesthesiologist. Detailed pre-anaesthetic checkup and proper evaluation of the airway gives an impression about the airway management while planning general anaesthesia. While most of the airways are easy to handle, some are categorized as difficult mask ventilation and/or difficult intubation. Presently, the most common predictors of difficult airway used are neck circumference (NC), thyromental distance (TMD), sternomental distance (SMD), inter-incisor gap, Cormack Lehane score. A single parameter may not correctly estimate difficult airway accurately and often multiple parameters are required for proper assessment. Hereby, two or more different parameters taken together are more reliable for assessment and have higher sensitivity and specificity in predicting difficult airway/intubation. Thereby, this study will be undertaken to compare the Ratios of NC-TMD and Ht-TMD in predicting the difficult tracheal intubation. Also, To calculate the IDS (Intubation Difficulty Score) during intubation. 
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