| CTRI Number |
CTRI/2023/05/052466 [Registered on: 10/05/2023] Trial Registered Prospectively |
| Last Modified On: |
27/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Other |
|
Public Title of Study
|
A prospective observational study to Correlate Mechanical power and outcome in critically ill ICU patients. |
|
Scientific Title of Study
|
Correlation of Mechanical power and outcome in critically ill ICU patients : An observational study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Afzal Azim |
| Designation |
Professor, Department of Critical Care Medicne |
| Affiliation |
Sanjay Gandhi Postgraduate Institute of Medical Sciences |
| Address |
Department Of Critical Care Medicine,
Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow. Uttar Pradesh-226014
Lucknow UTTAR PRADESH 226014 India |
| Phone |
9984988393 |
| Fax |
|
| Email |
draazim2002@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Afzal Azim |
| Designation |
Professor, Department of Critical Care Medicne |
| Affiliation |
Sanjay Gandhi Postgraduate Institute of Medical Sciences |
| Address |
Department Of Critical Care Medicine,
Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow. Uttar Pradesh-226014
Lucknow UTTAR PRADESH 226014 India |
| Phone |
9984988393 |
| Fax |
|
| Email |
draazim2002@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Teenu singh |
| Designation |
Senior resident, Department of Critical Care Medicne |
| Affiliation |
Sanjay Gandhi Postgraduate Institute of Medical Sciences |
| Address |
Department Of Critical Care Medicine,
Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow. Uttar Pradesh-226014
Lucknow UTTAR PRADESH 226014 India |
| Phone |
9468568828 |
| Fax |
|
| Email |
drtnusingh@gmail.com |
|
|
Source of Monetary or Material Support
|
| SANJAY GANDHI POSTGRADUATE INSTITUTE OF MEDICAL SCIENCES, LUCKNOW |
|
|
Primary Sponsor
|
| Name |
NOT APPLICABLE |
| Address |
NOT APLLICABLE |
| Type of Sponsor |
Other [NOT APPLICABLE] |
|
|
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 AFZAL AZIM |
Critical Care Medicine Dept of SGPGI, Lucknow |
Department of critical care medicine, Sanjay Gandhi Postgraduate Institute of Medical Sciences, lucknow, Uttar Pradesh-226014 Lucknow UTTAR PRADESH |
9984988393
draazim2002@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETICS COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: J22||Unspecified acute lower respiratory infection, |
|
|
Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Age ≥ 18 years
Invasive controlled mechanical ventilation treatment
Estimated mechanical ventilation treatment for more than 48 hours |
|
| ExclusionCriteria |
| Details |
Age <18 years
Pregnancy
Patients on weaning mode of ventilation |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mortality outcome in ICU |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Number of ventilator-free days (defined as the number of days from successful weaning to day 28, with patients who died before weaning being deemed to have no ventilator- free days),
Length of ICU stay and
Length of hospital stay |
28 day |
|
|
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)
|
17/05/2023 |
| 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="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Critically ill patients with acute respiratory failure are usually exposed to high intensity mechanical
ventilation making them prone to ventilation induced lung injury. Ventilator/ventilation-induced lung
injuries (VILI) result from the interaction between the ventilator delivers to the lung parenchyma
and way of accepting by lung parenchyma. The ventilator-generated causes of VILI include the
pressures, volume, flow, and respiratory rate. On the basis of basic thermodynamic principles,
energy transfer rate (mechanical power) from ventilator to the lung tissue attributed to lung injury.
If we consider the ventilatory setting, it is quite clear that tidal volume, pressures and flow are all
components of the energy load, which, expressed per unit of time, is the mechanical power. Finding
the correlation between mechanical power and VILI is important because Mechanical power include
all the variable that have implicated in lung injury that is driving pressure, respiratory rate, tidal
volume. So, in this observational study, we will review the clinical profile of the patients, calculate
mechanical power and will observe the ICU mortality as primary clinical outcome of this study and
the number of ventilator-free days (defined as the number of days from successful weaning to day
28, with patients who died before weaning being deemed to have no ventilator-free days), length of
ICU stay and length of hospital stay will be measured as secondary outcomes. Duration of the study
will be 18 months.
|