| CTRI Number |
CTRI/2024/08/072581 [Registered on: 16/08/2024] Trial Registered Prospectively |
| Last Modified On: |
14/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluating heart,lung and diaphragm ultrasound as predictor of successful weaning from mechanical ventilation in ICU patients. |
|
Scientific Title of Study
|
CARDIAC ULTRASOUND IN ADDITION TO LUNG AND DIAPHRAGM ULTRASOUND AS A PREDICTOR OF SUCCESSFUL WEANING FROM MECHANICAL VENTILATION IN PATIENTS ADMITTED IN INTENSIVE CARE UNIT. |
| 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 MEENA K S |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Anaesthesiology B L Taneja Block Maulana Azad Medical College Bahaddur Shah Zafar Marg New Delhi 110002
India
Central
DELHI
110002
India |
| Phone |
8105559329 |
| Fax |
|
| Email |
meenaksvas@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Kohli |
| Designation |
Associate Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room number 415 , 4th floor Department of Anaesthesiology BL Taneja Block Maulana Azad Medical College Bahaddur Shah Zafar Marg New Delhi
Central
DELHI
110002
India |
| Phone |
9818073402 |
| Fax |
|
| Email |
dramitkohli@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit Kohli |
| Designation |
Associate Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room number 415, 4th floor Department of Anesthesia BL Taneja Block Maulana Azad Medical College New Delhi
Central
DELHI
110002
India |
| Phone |
9818073402 |
| Fax |
|
| Email |
dramitkohli@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College and associated Lok Nayak Hospital, Bahadur Shah Zafar Marg , New Delhi -110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Maulana Azad Medical college and associated Lok Nayak hospital , Bahadur Shah Zafar Marg New Delhi |
| 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 Meena K S |
Lok Nayak Hospital |
Department of Anesthesiology B L Taneja Block Maulana Azad Medcal College Bahadur shah zafar marg new delhi
Central
DELHI |
08105559329
meenaksvas@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Maulana Azad Medical college and associated Hospitals |
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 |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 18 years to 65 years
2. mechanical ventilation for minimum 48 hours and maximum 7 days. |
|
| ExclusionCriteria |
| Details |
1. patients with history of neuromuscular disease
2.patients with history of diaphragmatic dysfunction
3. patients with chest tube in situ
4. patients with pneumothorax and pneumomediastinum
5.patients with chronic obstructive pulmonary disease
6.pregnant patients
7.patients with known heart failure
8.significant cardiac arrythmia |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate left atrial pressure (LAP) as a predictor of successful weaning from mechanical ventilation in ICU patients. |
30minutes from spontaneous breathing trial |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate change in velocity time integral to passive leg raise, peak early and peak atrial velocity trans mitral flow from pulsed wave doppler and early diastolic mitral annulus velocity based on tissue doppler imaging were measured
Lung ultrasound score as predictor of successful weaning from mechanical ventilation in ICU patients
Diaphragm thickness fraction as predictor of successful weaning from mechanical ventilation in ICU patients
The number of patients requiring non invasive ventilation or reintubation within 24 hours of extubation
time to reintubation or non invasive ventilation |
Rapid shallow breathing index at 5 and 30 minutes of spontaneous breathing trial
lung ultrasound score at 30 minutes of spontaneous breathing trial
Diaphragm thickness fraction at 30 minutes of spontaneous breathing trial
within 24 hours from extubation
within 24 hours from extubation |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
25/08/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
This is a prospective observational study, predicting successful weaning in mechanically ventilated patients admitted in ICU of Lok Nayak Hospital New Delhi who are undergoing spontaneous breathing trial by measuring left atrial pressure, change in velocity time integral to passive leg raise, E/A ratio , E/e’ ratio, lung ultrasound score and diaphragm thickness fraction by performing cardiac, lung and diaphragm ultrasound respectively, rapid shallow breathing index at specified time of spontaneous breathing trial . Following this patients will be extubated and assessed for success of weaning and the need of non invasive ventilation or reintubation for 24 hours by doing arterial blood gas analysis 1st and 6hours of post extubation. |