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CTRI Number  CTRI/2024/05/067823 [Registered on: 22/05/2024] Trial Registered Prospectively
Last Modified On: 16/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Comparison of Two Clinical Methods for Prediction of Difficult Airway for anaesthesia 
Scientific Title of Study   A Cross sectional Observational Study to Evaluate Predictive Value of Modified Mallampati Test Alone & in Conjunction with Voice Analysis for Difficult Laryngoscopy During 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  Dr Debraj Roy 
Designation  Post Graduate Trainee 
Affiliation  KPC Medical College and Hospital 
Address  Room No 233,Block 2,2nd Floor Department of Anaesthesiology, KPC Medical College and Hospital, Jadavpur Kolkata-700032 West Bengal India

South Twentyfour Parganas
WEST BENGAL
700032
India 
Phone  9051116453  
Fax    
Email  debcnmch@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sourabh Roy 
Designation  Professor 
Affiliation  KPC Medical College and Hospital 
Address  Room No 233,Block 2,2nd Floor Department of Anaesthesiology, KPC Medical College and Hospital, Jadavpur Kolkata-700032 West Bengal India

South Twentyfour Parganas
WEST BENGAL
700032
India 
Phone  9836275531  
Fax    
Email  drsourabhroy@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sourabh Roy 
Designation  Professor 
Affiliation  KPC Medical College and Hospital 
Address  Room No 233,Block 2,2nd Floor Department of Anaesthesiology, KPC Medical College and Hospital, Jadavpur Kolkata-700032 West Bengal India


WEST BENGAL
700032
India 
Phone  9836275531  
Fax    
Email  drsourabhroy@gmail.com  
 
Source of Monetary or Material Support  
KPC Medical College and Hospital 1F, Raja Subodh Chandra Mallick Road, Jadavpur, Kolkata-700032, West Bengal 
 
Primary Sponsor  
Name  KPC Medical College and Hospital 
Address  1F, Raja Subodh Chandra Mallick Road, Jadavpur, Kolkata-700032, West Bengal 
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 
Dr Debraj Roy  KPC Medical College and Hospital  Department of Anaesthesiology, Room no 232,1F, Raja Subodh Chandra Mallick Road, Jadavpur, Kolkata-700032, West Bengal
Kolkata
WEST BENGAL 
9051116453

debcnmch@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, KPC Medical College & Hospital, Jadavpur   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 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.Patients planned for elective Surgery under General Anaesthesia with tracheal intubation
2.Patients with ASA Grade I and II
 
 
ExclusionCriteria 
Details  1.Patients with ASA Grade III and IV
2.Patient with a previous history of speech disorders,larengeal & vocal cord diseases,
cleft palate, craniofacial syndromes, craniofacial trauma, previous oral and maxillofacial surgery,
3.Patient with hearing or perception abnormalities, mental or central nervous system diseases,
4.Pregnancy
5.Patients refusing consent
6.Patient admitted for emergency surgery.
7.History of difficult laryngoscopy in past
8.Patients participated in other relevant clinical investigation in the past 3 months
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the predictive potential of modified Mallampati test alone and in conjunction with voice parameters for difficult laryngoscopy
 
During pre anaesthetic check up((baseline) and laryngoscopy before intubation(4wks) 
 
Secondary Outcome  
Outcome  TimePoints 
1.To determine correlation of different voice parameters to difficult laryngoscopy
2.To determine predictive value of modified Mallampati test for difficult laryngoscopy  
During pre anaesthetic check up (base line) & laryngoscopy before intubation(4wks) 
 
Target Sample Size   Total Sample Size="250"
Sample Size from India="250" 
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)   01/07/2024 
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="6"
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 - NO
Brief Summary  

Airway risk assessment is an essential part of the preoperative anaesthetic protocol. Numerous investigations have been conducted in an effort to predict the occurrence of difficult airway through physical examination & modified Mallampati test is the most popular one. But Research has shown that it only had moderate ability to predict difficult airway.

Voice signal is a more recent novel and comprehensive indicator that can reflect both   anatomical structure and function of the airway. So, voice analysis may offer a way to predict difficulty in airway manipulation.

This study aimed to determine whether acoustic features are valuable as method to predict difficult laryngoscopy (DL) when it is used alone and in conjunction with modified Mallampati test in patients scheduled to undergo elective surgery under general anaesthesia.

This study will include 250 adult patients who will be undergoing elective surgery under general anaesthesia with tracheal intubation. Preoperatively, clinical airway evaluation will be performed and modified Mallampati grading will be done.The Class I &II is associated with easy laryngoscopy & Class III or IV is usually associated with difficult laryngoscopy.

Five phonemes considered as the vowels a, e, i, o,u  will be recorded and their first four formants (describe as f1, f2, f3, f4 ) will be analysed. Laryngoscopy will be done after induction of anaesthesia & adequate muscle relaxation. Difficult Laryngoscopy will be called when the anaesthetist, using direct laryngoscopy, classified the patient as 3 or 4 in accordance with the Cormack and Lehane classification system.

It is expected that voice parameters in conjunction with modified Mallampati test will have higher predictive value to predict difficult laryngoscopy & intubation than modified mallampati test alone during general anaesthesia.


 
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