| CTRI Number |
CTRI/2023/07/055765 [Registered on: 27/07/2023] Trial Registered Prospectively |
| Last Modified On: |
26/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To Assess The Importance of Doing Trans-thoracic echocardiography during the process of weaning off from Mechanical Ventilation. |
|
Scientific Title of Study
|
Evaluation Of Predictive Value Of Left Ventricular Dysfunction On Mechanical Ventilation Weaning Failure. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Paras Bajaj |
| Designation |
DrNB resident |
| Affiliation |
Paras Hospitals Gurgaon |
| Address |
Department of Critical Care Medicine , Paras Hospitals Gurgaon
Gurgaon
HARYANA
122003
India |
| Phone |
9971759519 |
| Fax |
|
| Email |
drparasbajaj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nitin Jain |
| Designation |
Head of department |
| Affiliation |
Paras Hospitals Gurgaon |
| Address |
Department of Critical care Medicine
Paras Hospitals Gurgaon
Gurgaon
HARYANA
122003
India |
| Phone |
9818155350 |
| Fax |
|
| Email |
drnitin.jain@parashospitals.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nitin Jain |
| Designation |
Head of department |
| Affiliation |
Paras Hospitals Gurgaon |
| Address |
Department of Critical Care Medicine
Paras Hospitals Gurgaon
Gurgaon
HARYANA
122003
India |
| Phone |
9818155350 |
| Fax |
|
| Email |
drnitin.jain@parashospitals.com |
|
|
Source of Monetary or Material Support
|
| Dr Nitin jain, department of critical care medicine , paras hospitals gurgaon |
|
|
Primary Sponsor
|
| Name |
Paras Hospitals Gurgaon |
| Address |
paras hospitals gurgaon sector 43 gurgaon haryana |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Paras Bajaj |
Paras Hospitals, Gurgaon |
PARAS HOSPITALS GURGAON SECTOR 43 HARYANA
Gurgaon
HARYANA |
8178447996
drparasbajaj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ethics committee paras hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J440||Chronic obstructive pulmonary disease with acute lower respiratory infection, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
trans thoracic echocardiography |
echocardiography will be done in both cases of extubation success and extubation failure.
in cases of extubation or weaning failiure, assessment of diastolic dysfunction will be done to rule out cardiac cause for weaning failure |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
any patient on mechanical ventilation who is planned for weaning from ventilation with no cardiac ailments |
|
| ExclusionCriteria |
| Details |
any patient with prior cardiac diseases like heart failure patient with low ejection fraction
any brain dead patient
any patient with prior systolic or diastolic dysfunction |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| evaluation of left ventricle dysfunction on weaning failure |
evaluation of left ventricle dysfunction on weaning failure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| IMPORTANCE OF LEFT VENTRICLE DYSFUNCTION IN WEANING FAILURE |
IMPORTANCE OF WEANING FAILURE |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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)
|
10/08/2023 |
| 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="0"
Months="6"
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
|
my trial will assess the predictive value of left ventricle dysfunction on mechanical ventilation weaning failure |