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CTRI Number  CTRI/2023/07/054834 [Registered on: 06/07/2023] Trial Registered Prospectively
Last Modified On: 05/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Comparing Ultrasound Guided Distance from Skin to Epiglottis and Hyomental Distance and their Ratios for Assessment of Difficult Laryngoscopy in Adult Patients Undergoing Elective Surgery Under General Anaesthesia  
Scientific Title of Study   Comparison of Ultrasound Guided Distance from Skin to Epiglottis Ratio and Hyomental Distance Ratio for Assessment of Difficult Laryngoscopy in Adult Patients Undergoing Elective Surgery Under General Anaesthesia  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Amala Tom  
Designation  1st year Post graduate student  
Affiliation  Guru Gobind Singh Indraprastha University  
Address  Department of anesthesia ABVIMS and Dr. RML Hospital Delhi

Central
DELHI
110001
India 
Phone  9946603282  
Fax    
Email  amalamarytom26@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mohandeep Kaur 
Designation  Professor and HOD 
Affiliation  Guru Gobind Singh Indraprastha University  
Address  Professor and HOD Department of Anesthesia ABVIMS and Dr. RML Hospital Delhi

Central
DELHI
110001
India 
Phone  9868952253  
Fax    
Email  mdkaur@gmail.com  
 
Details of Contact Person
Public Query  
Name  Amala Tom  
Designation  1st year Post graduate student  
Affiliation  Guru Gobind Singh Indraprastha University  
Address  Department of anesthesia ABVIMS and Dr. RML Hospital Delhi

Central
DELHI
110001
India 
Phone  9946603282  
Fax    
Email  amalamarytom26@gmail.com  
 
Source of Monetary or Material Support  
Department of anaesthesia ABVIMS and Dr RML Hospital Delhi 110001 
 
Primary Sponsor  
Name  Department of Anaesthesia  
Address  ABVIMS and DR. RML Hospital Delhi, 110001 
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 
Dr Amala Tom   Atal Bihari Vajpayee Institute of Medica Sciences and Dr. Ram Manohar Lohia Hospital   Department of anaesthesia ABVIMS and Dr RML Hospital Delhi 110001
Central
DELHI 		 9946603282

amalamarytom26@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, ABVIMS and Dr RML Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  66.00 Year(s)
Gender  Both 
Details  Age 18- 66 years
ASA grade I, II
Either sex
 
 
ExclusionCriteria 
Details  Trauma, tumour or deformity of upper airway
Patients with thyroid and neck swelling
Fracture and deformity of cervical spine
Past history of difficult intubation
Difficult mouth opening with inter- incisor gap of less than 3cm
BMI > 35kg/m2 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Ultrasound guided measurements of distance from skin to epiglottis & hyomental distance in neutral & extended positions & their ratios.  Preoperative assessment  
 
Secondary Outcome  
Outcome  TimePoints 
Number of attempts of intubation
Time taken for intubation
Requirement of any device like stylet or bougie
Requirement of any external manoeuvre or technique
Change of anaesthetist  		 During intubation  
 
Target Sample Size   Total Sample Size="228"
Sample Size from India="228" 
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)   15/07/2023 
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="9"
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
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  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 [amalamarytom26@gmail.com].

  6. For how long will this data be available start date provided 01-07-2025 and end date provided 01-07-2029?
    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   We propose this study to compare ultrasound guided distance from skin to epiglottis ratio and hyomental distance ratio for assessment of difficult laryngoscope in adult patients undergoing elective surgery under general anaesthesia as our primary objective and comparing ultrasound guided distance from skin to epiglottis ratio and hyomental distance ratio for assessment of difficult intubation as our secondary objective. 
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