| CTRI Number |
CTRI/2024/12/078493 [Registered on: 24/12/2024] Trial Registered Prospectively |
| Last Modified On: |
18/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Use of Translaryngeal Ultrasound to Assess Vocal Cords Before and After Extubation in ICU Patients |
|
Scientific Title of Study
|
Use of Translaryngeal Ultrasonography to Assess Vocal Cords Pre and Post Extubation in Mechanically Ventilated Patients |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
mohanraj murugannan |
| Designation |
Post Graduate Resident |
| Affiliation |
kovai medical center and hospital |
| Address |
Department of Critical Care Medicine
Kovai Medical Centre and Hospital
Coimbatore
Coimbatore
TAMIL NADU
641014
India |
| Phone |
9043683832 |
| Fax |
|
| Email |
mohanraj.jam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Magesh Parthiban |
| Designation |
Consultant |
| Affiliation |
kovai medical center and hospital |
| Address |
Department of Critical Care Medicine
Kovai Medical Centre and Hospital
Coimbatore
Coimbatore
TAMIL NADU
641014
India |
| Phone |
9953042741 |
| Fax |
|
| Email |
magesh.268@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Magesh Parthiban |
| Designation |
Consultant |
| Affiliation |
Kovai Medical Center and hospital |
| Address |
Department of Critical Care Medicine
Kovai Medical Centre and Hospital
Coimbatore
Coimbatore
TAMIL NADU
641014
India |
| Phone |
9953042741 |
| Fax |
|
| Email |
magesh.268@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kovai Medical Centre and Hospital
99,Avinashi road
Civil Aerodome post
Coimbatore
TamilNadu
India
pincode 641014 |
|
|
Primary Sponsor
|
| Name |
kmch |
| Address |
kovai medical center and hospital , Coimbatore 641014 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrMohanraj |
Kovai Medical Centre and Hospital |
Department of Critical care medicine
Kovai Medical Centre and Hospital
Coimbatore
Coimbatore
TAMIL NADU |
9043683832
mohanraj.jam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| kovai medical center and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J99||Respiratory disorders in diseasesclassified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Translaryngeal ultrasonography |
I am using translaryngeal ultrasound to assess the vocal cords pre and post extubation to prevent risk of reintubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Neurocritically ill patients
Patients on mechanical ventilation more than 48 hours |
|
| ExclusionCriteria |
| Details |
Pregnancy
vocal cod palsy
previous tracheostomy |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Risk of reintubation at 48 hours |
2 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
incidence of ventilator associated pneumonia ,stridor ,aspiration
need for tracheostomy
successfull decannulation of tracheostomised patients
association of vocal fold displacement velocity and vocal cord paralysis
length of icu stay
28 day mortality
|
28 days |
|
|
Target Sample Size
|
Total Sample Size="275"
Sample Size from India="275"
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)
|
30/12/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Use of translaryngeal ultrasonography to assess vocal cords pre and post extubation in mechanically ventilated patients to compare the effucacy of ultrasound with fibreoptic bronchoscopy to analyse reintubation rate ,to identify the incidence of vap |