| CTRI Number |
CTRI/2024/11/076279 [Registered on: 05/11/2024] Trial Registered Prospectively |
| Last Modified On: |
04/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To determine the association between energy delivered by the mechanical ventilator and liberation from the mechanical ventilator |
|
Scientific Title of Study
|
A prospective observational study of the association between mechanical power and weaning outcome in mechanically ventilated adult 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 Deepak Raj Kallingapuram Shaju |
| Designation |
DrNB Fellow |
| Affiliation |
Medanta The Medicity Gurgaon |
| Address |
Medanta Institute of Critical Care and Anaesthesiology Medanta The Medicity Gurgaon Sector 38 HARYANA 122001 India
Institute of Critical Care and Anesthesiology Medanta The Medicity Sector 38 Gurgaon Haryana 122001
Gurgaon
HARYANA
122001
India |
| Phone |
7012080243 |
| Fax |
|
| Email |
deepakrajks007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Divya Pal |
| Designation |
Senior Consultant Critical Care |
| Affiliation |
Medanta The Medicity Gurgaon |
| Address |
Institute of Critical Care and Anesthesiology Medanta The Medicity Sector 38 Gurgaon Haryana 122001
Institute of Critical Care and Anesthesiology Medanta The Medicity Sector 38 Gurgaon Haryana 122001
Gurgaon
HARYANA
122001
India |
| Phone |
7838316282 |
| Fax |
|
| Email |
divyapalarora@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Divya Pal |
| Designation |
Senior Consultant Critical Care |
| Affiliation |
Medanta The Medicity Gurgaon |
| Address |
Institute of Critical Care and Anesthesiology Medanta The Medicity Sector 38 Gurgaon Haryana 122001
Institute of Critical Care and Anesthesiology Medanta The Medicity Sector 38 Gurgaon Haryana 122001
Gurgaon
HARYANA
122001
India |
| Phone |
7838316282 |
| Fax |
|
| Email |
divyapalarora@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Critical Care and Anesthesiology Medanta The Medicity Sector 38 Gurgaon Haryana 122001 |
|
|
Primary Sponsor
|
| Name |
Dr. Deepak Raj Kallingapuram Shaju |
| Address |
Institute of Critical Care and Anaesthesiology Medanta The Medicity Gurgaon 122001
|
| 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 Deepak Raj Kallingapuram Shaju |
Medanta The Medicity |
Institute of Critical Care and Anesthesiology Medanta The Medicity Sector 38 Gurgaon Haryana 122001
Gurgaon
HARYANA |
7012080243
deepakrajks007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medanta Institutional Ethics Committee (MIEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J958||Other intraoperative and postprocedural complications and disorders of respiratory system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1 Age greater than 18 years
2 Patients who received mechanical ventilation for more than 24 hours
3 First ICU admission
|
|
| ExclusionCriteria |
| Details |
1 Patients less 18 years of age
2 Neuromuscular disease
3 Tracheostomised patients
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mechanical power and association with weaning outcome |
1 hour prior
to spontaneous breathing trial |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mechanical power surrogate variables and association with weaning outcome |
1 hour prior
to spontaneous breathing trial |
|
|
Target Sample Size
|
Total Sample Size="162"
Sample Size from India="162"
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)
|
15/11/2024 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Adult patients admitted to ICU, intubated on mechanical ventilator who fulfil the eligibility criteria and are ready to be weaned from mechanical ventilator are selected. One hour prior to spontaneous breathing trial, mechanical power, laboratory parameters, set and displayed ventilator parameters, demographic data, comorbid conditions, arterial blood gas parameters will be noted. Mechanical power will be calculated according to Gattinoni’s simplified mechanical power equation. The calculated mechanical power and its surrogate variables will be statistically analysed for any association between weaning outcome. |