| CTRI Number |
CTRI/2022/03/040909 [Registered on: 08/03/2022] Trial Registered Prospectively |
| Last Modified On: |
07/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of diaphragm( a respiratory muscle) ultrasoundin predicting weaning( taking off the ventilator) outcomes from mechanical ventilation( artificial breathing system) |
|
Scientific Title of Study
|
Evaluation of diaphragm ultrasonography in predicting weaning outcomes from mechanical ventilation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Apoorva Gupta |
| Designation |
DM Resident, Critical care medicine department, DMCH, Ludhiana. |
| Affiliation |
Baba Farid University of Health Sciences, Faridkot, Punjab. |
| Address |
Room no. N69, New PG Hostel, Dayanand Medical College and Hospital, Ludhiana, India.
Ludhiana
PUNJAB
141001
India |
| Phone |
8840838997 |
| Fax |
|
| Email |
aguptaa13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Gunchan Paul |
| Designation |
Associate Professor |
| Affiliation |
DMCH, Ludhiana |
| Address |
Critical care medicine department, Dayanand Medical College and Hospital, Ludhiana, India.
Ludhiana
PUNJAB
141001
India |
| Phone |
9878645330 |
| Fax |
|
| Email |
gunchan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Apoorva Gupta |
| Designation |
DM Resident, Critical care medicine department, DMCH, Ludhiana. |
| Affiliation |
DMCH, Ludhiana |
| Address |
Room no. N69, New PG Hostel, Dayanand Medical College and Hospital, Ludhiana, India.
Ludhiana
PUNJAB
141001
India |
| Phone |
8840838997 |
| Fax |
|
| Email |
aguptaa13@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dayanand Medical College and Hospital, Ludhiana, Punjab. |
|
|
Primary Sponsor
|
| Name |
Dayanand Medical College and Hospital Ludhiana India |
| Address |
Dayanand Medical College and Hospital, Ludhiana, Punjab. |
| 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 |
| Apoorva Gupta |
Dayanand Medical College and Hospital |
Medical and surgical intensive care units
Ludhiana
PUNJAB |
8840838997
aguptaa13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Dayanand Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J969||Respiratory failure, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients who have been mechanically ventilated for more than 24 hrs and are now being planned for weaning after their cause for which they were on invasive mechanical ventilation has been resolved or is resolving |
|
| ExclusionCriteria |
| Details |
1. Age <18 yrs
2. Neuromuscular diseases
3. Flail chest or multiple rib fractures
4. Chest tube in place
5. Morbid obesity
6. Malnutrition
7. Spinal cord injuries |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| prediction of weaning outcomes. |
at baseline, 30 minutes and 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Early weaning
2.Improvement in number of ventilator free days of the patient. |
Number of ventilator free days the patient |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
16/03/2022 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The aim of this study is to assess the role of diaphragm parameters using ultrasound during weaning from invasive mechanical ventilation and to find out cut off of diaphragm excursion time index and tissue doppler imaging values and also to compare ultrasonographic values with lung mechanics and traditional weaning criteria. It will be a prospective observational study to be conducted in the ICUs of Dayanand Medical College and Hospital, Ludhiana. The study period will be of one year. |