| CTRI Number |
CTRI/2024/08/071806 [Registered on: 01/08/2024] Trial Registered Prospectively |
| Last Modified On: |
31/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Using Ultrasound to Measure Diaphragm Strength for predicting weaning success in ICU patients from mechanical ventilator.
|
|
Scientific Title of Study
|
Evaluation of Diaphragmatic thickness fraction by Ultrasonography as a predictor for successful weaning from mechanical ventilation in ICU 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 |
Dr Muskan Dogney |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical sciences, Patna |
| Address |
DGB, Department of Emergency Medicine, All India Institute of Medical sciences, Patna
Patna
BIHAR
801505
India |
| Phone |
7484874340 |
| Fax |
|
| Email |
muskan11861@aiimspatna.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Deepak Kumar |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical sciences, Patna |
| Address |
DGB, Department of Emergency Medicine, All India Institute of Medical sciences, Patna
Patna
BIHAR
801505
India |
| Phone |
9717864257 |
| Fax |
|
| Email |
dr.deepak11706@aiimspatna.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Muskan Dogney |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical sciences, Patna |
| Address |
DGB, Department of Emergency Medicine, All India Institute of Medical sciences, Patna
Patna
BIHAR
801505
India |
| Phone |
7484874340 |
| Fax |
|
| Email |
muskan11861@aiimspatna.org |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Patna
Phulwarisharif
Pin: 801505
Patna, Bihar |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Patna |
| Address |
All India Institute of Medical Sciences, Patna,
Phulwarisharif, Patna, Bihar, 801505 |
| Type of Sponsor |
Government 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 Muskan Dogney |
All India Institute of Medical sciences, Patna |
Intensive care unit of Department of Emergency medicine
Patna
BIHAR |
7484874340
muskan11861@aiimspatna.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS PATNA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age 18 to 65 years.
Mechanical ventilation for minimum 12 hours and maximum 7 days.
Intubated and mechanically ventilated patient ready to be weaned. |
|
| ExclusionCriteria |
| Details |
Patients with history of neuromuscular disease
Patients with history suggestive of diaphragmatic dysfunction
Patients with chest tube in situ
Pregnant Patients
Tracheostomized patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the sensitivity and specificity of Diaphragmatic Thickening Fraction (DTF) as a predictor for successful weaning in ICU patients. |
RSBI assessed 60 min after successful Spontaneous Breathing trial.
ABG done at 1 hour and 6 hapur after extubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
11/08/2024 |
| 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="5"
Days="15" |
|
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
|
One of the commonest causes of difficult weaning has been diaphragmatic dysfunction, which progressively worsens while using mechanical ventilation. USG examination allows the direct visualization of the diaphragm thickness during active breathing & reflect the magnitude of diaphragmatic effort. Ultrasound is safe, non-invasive, without radiation hazards, and available at the bedside modality for assessment of lung and diaphragm for weaning of ICU patients. The study expects to evaluate diaphragmatic thickness fraction (DTF) assessed by ultrasonography as predictor during weaning from mechanical ventilation. This may provide a novel, non-invasive approach to predict successful extubation, potentially reducing reintubation rates and guiding personalized weaning strategies in critical care settings, thereby enhancing patient outcomes and optimizing resource utilization. |