FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/12/038447 [Registered on: 06/12/2021] Trial Registered Prospectively
Last Modified On: 01/12/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective Observational Study 
Study Design  Other 
Public Title of Study   Voice recording and its analysis before operation in pre-anaesthetic check-up as a means to judge larynx aperture by using an instrument 
Scientific Title of Study   Pre-operative Evaluation of Voice as a Predictor of Difficult Laryngoscopy 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aditi Yadav 
Designation  Post Graduate Student 
Affiliation  Maulana Azad Medical College 
Address  Room NO. 301, Department of Anaesthesiology and Intensive Care, third floor, B. L. Taneja Block, Maulana Azad Medical Colllege

Central
DELHI
110002
India 
Phone  8447099275  
Fax    
Email  aditiyadav1187@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kirti Nath Saxena 
Designation  Director Professor and Head of Department, Department of Anaesthesiology and Intensive Care, MAMC 
Affiliation  Maulana Azad Medical College 
Address  Room No. 301, Department of Anaesthesiology and Intensive Care, third floor, B. L. Taneja Block, Maulana Azad Medical College

Central
DELHI
110002
India 
Phone  011-23238085  
Fax    
Email  kirtinath@gmail.com  
 
Details of Contact Person
Public Query  
Name  Aditi Yadav 
Designation  Post Graduate Student 
Affiliation  Maulana Azad Medical College 
Address  Room No. 301, Department of Anaesthesiology and Intensive Care, third floor, B. L. Taneja Block, Maulana Azad Medical College

Central
DELHI
110002
India 
Phone  8447099275  
Fax    
Email  aditiyadav1187@gmail.com  
 
Source of Monetary or Material Support  
OT Block first, second and third floor Maulana Azad Medical College and Lok Nayak Hospital 
 
Primary Sponsor  
Name  Maulana Azad Medical College and associated Hospital 
Address  Room No.-302, Department of Anaesthesiology and Intensive Care, third floor, B. L. Taneja Block, Maulana Azad Medical College 
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 Aditi Yadav  Lok Nayak Hospital  OT Complex first, second and third floor
Central
DELHI 		 8447099275

aditiyadav1187@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Maulana Azad Medical College  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 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients undergoing elective surgery under general anaesthesia
2. ASA physical status 1 and 2 
 
ExclusionCriteria 
Details  1. Patients with significant oral or laryngeal pathologies who are unable to pronounce vowels
2. Patients having psychiatric issues or havig mental retardation
3. Patients requiring awake intubation 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Correlation between preoperative voice formants: F1,F2,F3,F4,F5 and Cormack-Lehane grading  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
1. Correlation between preoperative voice formants and Modified Mallampati Test
2. Correlation of combination of preoperative voice formants and Modidfied Mallampati test 		 Baseline 
 
Target Sample Size   Total Sample Size="220"
Sample Size from India="220" 
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)   11/12/2021 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
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

  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 - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [aditiyadav1187@gmail.com].

  6. For how long will this data be available start date provided 24-08-2023 and end date provided 24-08-2026?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   Airway assessment and prediction of difficult airway forms an important part of pre-anaesthetic check-up. The current predictive tests lag in some form or other to accurately predict difficult airway. The present study evaluates voice with the help of Praat software in 220 patients and provides a quantitative data in form of formants to predict difficult laryngoscopy. Adult patients aging 18-60 years of either sex and those belonging to ASA PS I and II who are scheduled to undergo elective surgeries under general anaesthesia will be recruited for participation in this study. Patients with significant oral or laryngeal pathologies who are unable to pronounce vowels, those having psychiatric issues or mental retardation and those requiring awake intubation will be excluded from the study. Voice recording, its analysis and the Modified Mallampati Test will be performed for all eligible patients during pre-anaesthetic check-up. Standard technique of anaesthesia will be used and Cormack- Lehane Grade will be noted after direct laryngoscopy. Primary objective will be to correlate voice formants with the Cormack Lehane grade. Secondary objectivee will be: to compare voice formants and Modified Mallampati class and to correlate combination of voice formants and Modified Mallampati class with Cormack-Lehane Grade. Collected data will be entered in Microsoft excel and then will be analysed and statistically evaluated using SPSS-PC-25.0 version. Appropriate statistical tests will be applied.  
Close