| CTRI Number |
CTRI/2024/09/074302 [Registered on: 24/09/2024] Trial Registered Prospectively |
| Last Modified On: |
12/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
prospective |
| Study Design |
Other |
|
Public Title of Study
|
Integrated ultrasound protocol in predicting weaning success and extubation failure |
|
Scientific Title of Study
|
Integrated ultrsound protocol in predicting weaning success and extubation failure:A prospective observational study |
| 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 Ashwini Kisan Mane |
| Designation |
Junior resident ,Department of Critical care , Apollo Hospital Navi Mumbai |
| Affiliation |
Apollo hospital |
| Address |
Department of critical care Apollo hospitals,Parsik Hill Road , Sector 23, CBD Belapur, Navi Mumbai , Maharashtra, 400614, India
Department of critical care Apollo hospitals,Parsik Hill Road , Sector 23, CBD Belapur, Navi Mumbai , Maharashtra, 400614, India
Mumbai (Suburban)
MAHARASHTRA
410210
India |
| Phone |
07994661907 |
| Fax |
|
| Email |
ashwi2490@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gunadhar Padhi |
| Designation |
Senior Consultant , Department of Critical Care , Apollo Hopsital Navi Mumbai |
| Affiliation |
Apollo hospital |
| Address |
Department of critical care Apollo hospitals,Parsik Hill Road , Sector 23, CBD Belapur, Navi Mumbai , Maharashtra, 400614, India
Department of critical care Apollo hospitals,Parsik Hill Road , Sector 23, CBD Belapur, Navi Mumbai , Maharashtra, 400614, India
Mumbai (Suburban)
MAHARASHTRA
400614
India |
| Phone |
9619528973 |
| Fax |
|
| Email |
gunadharpadhi@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashwini Kisan Mane |
| Designation |
Junior Resident , Department Of Critical Care , Apollo Hospital Navi Mumbai |
| Affiliation |
Apollo hospitals navi mumbai |
| Address |
Department of critical care Apollo hospitals,Parsik Hill Road , Sector 23, CBD Belapur, Navi Mumbai , Maharashtra, 400614, India
Department of critical care Apollo hospitals,Parsik Hill Road , Sector 23, CBD Belapur, Navi Mumbai , Maharashtra, 400614, India
Mumbai (Suburban)
MAHARASHTRA
410210
India |
| Phone |
|
| Fax |
|
| Email |
ashwi2490@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of critical care Apollo hospitals,Parsik Hill Road , Sector 23, CBD Belapur, Navi Mumbai , Maharashtra, 400614, India |
|
|
Primary Sponsor
|
| Name |
Ashwini Mane |
| Address |
Critical Care Department ,Apollo Hospital , Plot no #13, off uran road, Parsik Hill road , Sector 23 , CBD Belapur , Navi Mumbai Maharashtra , 400614, India |
| Type of Sponsor |
Other [Self] |
|
|
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 Ashwini Kisan Mane |
Apollo hospitals navi mumbai |
Department of critical care Apollo hospitals,Parsik Hill Road , Sector 23, CBD Belapur, Navi Mumbai , Maharashtra, 400614, India
Mumbai (Suburban)
MAHARASHTRA |
07994661907
ashwi2490@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee-human research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Y62-Y69||Misadventures to patients during surgical and medical care, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1) The patient who gives consent
2)Patients who had been on mechanical ventilation for more than 48 hours were included in the study.
3) To be considered for SBT patients must have had a stable clinical status
|
|
| ExclusionCriteria |
| Details |
1)Patient doesnt give consent
2)short term mechanical ventilation less than 48 hours
3)Age less than 18 years
4)presence of cardiac arrhythmia
5)ICU acquired neuropathy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess weaning success and extubation failure |
48 HOURS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess respiratory complications
To assess mortality in patient |
30 days |
|
|
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)
|
27/09/2024 |
| 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)
|
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
|
weaning protocol have become popularized since the publication of guidelines by task force on ventilator discontinuation , the aim of mechanical ventilation in intensive care unit is to support the patients respiration until the patient can maintain adequate ventilatory homeostasis , , weaning failure occurs in patient who fail the initial SBT and in patients have significantly higher mortality and morbidity rates , including a longer length of stay in ICU and in hospital and a greater chance of requiring transition to along term acute care facility or nursing home , thereby incurring greater heathcare costs , there fore objective assessment of patients before and during an SBT is needed to indentify predictors of weaning failure , the aim of the the study is to aseess the abiliy of integrated lung , diaphragmatic and cardiac ultrasound protocol to predict weaning success and extubation failure |