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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: J22||Unspecified acute lower respiratory infection,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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 
 
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    
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.

 
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