| CTRI Number |
CTRI/2023/03/050930 [Registered on: 21/03/2023] Trial Registered Prospectively |
| Last Modified On: |
20/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of Vocal change following Endotracheal intubation using Praat software |
|
Scientific Title of Study
|
Evaluation of Incidence of Dysphonia and Vocal Symptoms following Endotracheal Intubation using Praat Software-An Observational Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aravinth N |
| Designation |
Post Graduate |
| Affiliation |
Mahatma Gandhi Medical College and Research Institute |
| Address |
Department of Anaesthesiology ,
Mahatma Gandhi Medical College and Research Institute ,Pondicherry-cuddalore road,Pillaiyarkuppam.
Pondicherry -607402
Pondicherry
PONDICHERRY
607402
India |
| Phone |
8870000055 |
| Fax |
|
| Email |
aravinthnatarajantup@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Antony John Charles S |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi Medical College and Research Institute |
| Address |
Department of Anaesthesiology ,
Mahatma Gandhi Medical College and Research Institute ,Pondicherry-cuddalore road,Pillaiyarkuppam.
Pondicherry -607402
Pondicherry
PONDICHERRY
607 402
India |
| Phone |
9600931102 |
| Fax |
|
| Email |
anjocharlie@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Antony John Charles S |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi Medical College and Research Institute |
| Address |
Department of Anaesthesiology ,
Mahatma Gandhi Medical College and Research Institute ,Pondicherry-cuddalore road,Pillaiyarkuppam.
Pondicherry -607402
Pondicherry
PONDICHERRY
607 402
India |
| Phone |
9600931102 |
| Fax |
|
| Email |
anjocharlie@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Medical College and Research Institute , Pondicherry |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Medical College and Research Institute , Pondicherry |
| Address |
Mahatma Gandhi Medical College and Research Institute , Pondicherry -cuddalore Ecr road ,Pillaiyarkuppam
Pondicherry -607 402 |
| 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 |
| Aravinth N |
Mahatma Gandhi Medical College and Research Institute |
Department of Anaesthesiology ,Mahatma Gandhi Medical College and Research Institute , Pondicherry -Cuddalore ECR road ,Pillaiyarkuppam
Pondicherry -607 402
Pondicherry
PONDICHERRY |
8870000055
aravinthnatarajantup@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL HUMAN ETHICS COMMITTE |
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 |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.General anaesthesia with Endotracheal intubation.
2.Patient aged 18 years and above
3.Patient belonging to ASA-1 & ASA-2
4.Rule out Pre existing vocal cord lesions. |
|
| ExclusionCriteria |
| Details |
1.Endotracheal intubation during emergency surgery and in ICU
2.Patient with history of Preoperative URI or LRI within 14 days of recovery .
3.Reactive airway patients , and any surgery that include manipulation of larynx or tracheostomy and past laryngeal surgery.
4.Pregnant Woman |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of Incidence of Dysphonia and Vocal symptoms following Endotracheal Intubation using Praat Software |
2 hours and 24 hours after Extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Assessment and evaluation of acoustic vocal indices changes by comparing voice change before intubation and after extubation using PRAAT software.
2. To record the incidence of sore throat ,hoarseness, vocal fatigue ,throat clearing and throat pain following intubation.
3.To record the number of intubation attempts its influence on voice change.
4.To record any use of airway adjuncts like stylet ,bougie. |
2 hours and 24 hours after Extubation |
|
|
Target Sample Size
|
Total Sample Size="145"
Sample Size from India="145"
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)
|
14/04/2023 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Previous studies have already established that there is voice change after endotracheal intubation.Airway management is one of the significant responsibilities of a trained anaesthesiologist.Therefore ,a detailed observational study are required to evaluate the impact on laryngeal function after endotracheal intubation that is vocal acoustic changes on voice and vocal symptoms following endotracheal intubation by using PRAAT software by comparing the voice pre intubation and post extubation voice.
RESEARCH QUESTION : Does Post Endotracheal Intubation cause significant voice Change and vocal symptoms?
Inclusion criteria will be General Anaesthesia with Endotracheal intubation, patients aged 18 years and above belonging to ASA I-II, and to rule out any preexisting vocal cord lesions. Exclusion criteria will be Endotracheal intubation during emergency surgery and in ICU, patient with history of preoperative URI or LRI within 14 days of recovery, reactive airway and any surgery that include manipulation of larynx or tracheostomy and past laryngeal surgery, pregnant woman. The voice of the participants will be recorded and analysed preoperatively by using PRAAT software and will be compared with their voice postoperatively, 2 hours and 24 hours post extubation.
The acoustic analysis of voice will be performed by PRAAT software 6.2.14 version. The voice signal will be recorded with microphone inbuilt Macbook(laptop)M1 directly with sampling rate of 44100 Hz will be used. Prior to recording, patients will be asked to take a deep breath and to phonate vowels, /a/, /i/, or /u/. The Macbook microphone will be held at a distance of 10 cm from the mouth of the patient with ambient noise below 50 db.
PRAAT software 6.2.14 version will be used to record voice related parameters like Mean pitch (Fundamental frequency), Jitter%, Shimmer(dB), Harmonics to noise ratio (db) and Maximum Phonation time The vocal symptoms will be evaluated in all patients in the study and it includes Sore throat, hoarseness, vocal fatigue, throat clearing and throat pain. |