| 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
|
|
|
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
|
|
|
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.
|