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CTRI Number  CTRI/2025/07/091172 [Registered on: 18/07/2025] Trial Registered Prospectively
Last Modified On: 19/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective cohort 
Study Design  Single Arm Study 
Public Title of Study   To study the role of mechanical power of lungs and its correlation with mortality  
Scientific Title of Study   Mechanical power and ventilator variables in patients with acute respiratory distress syndrome 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Yashita Joshi 
Designation  DM Senior resident 
Affiliation  ESIC Medical College and Hospital  
Address  Department of Critical Care Medicine (CCM), ESIC Medical College and Hospital, Faridabad, Haryana

Faridabad
HARYANA
121012
India 
Phone  9897911206  
Fax    
Email  yashita201095@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Harish Sachdeva 
Designation  Professor Critical Care Medicine (CCM) 
Affiliation  ESIC Medical College and Hospital 
Address  Department of Critical Care Medicine, ESIC Medical College and Hospital, Faridabad, Haryana

Faridabad
HARYANA
121012
India 
Phone  9897911206  
Fax    
Email  Sachdeva_hc04@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Yashita joshi 
Designation  DM senior resident  
Affiliation  ESIC Medical College and Hospital 
Address  Department of Critical Care Medicine, ESIC Medical College and Hospital, Faridabad, Haryana

Faridabad
HARYANA
121012
India 
Phone  9897911206  
Fax    
Email  yashita201095@gmail.com  
 
Source of Monetary or Material Support  
ESIC Medical College and Hospital, Faridabad, Haryana, 121001 
 
Primary Sponsor  
Name  ESIC Medical College and Hospital  
Address  NIT 3, Faridabad, Haryana,121012 
Type of Sponsor  Government medical college 
 
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 Yashita Joshi  ESIC Medical College and Hospital   Department of Critical Care Medicine (CCM) , 3rd floor
Faridabad
HARYANA 
09897911206

yashita201095@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee ESIC Medical College and Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J80||Acute respiratory distress syndrome,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Acute Respiratory Distress Syndrome patients as per Berlin definition criteria, who are on invasive volume-controlled mechanical ventilation 
 
ExclusionCriteria 
Details  Spontaneously breathing patient on invasive ventilation
Pressure control mode
Death on the day of admission
Cariogenic pulmonary oedema
History of chronic obstructive or restrictive lung disease
Pregnancy
Body mass index more than 35 kg per metre square
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Association of mechanical power between survivors and non survivors of ARDS  0 hours, 4 hours subsequently for maximum 14 days 
 
Secondary Outcome  
Outcome  TimePoints 
Correlation of mechanical power with primary ventilator variables like tidal volume, respiratory rate, driving pressure and amount of aerated lung tissue among survivors and non survivors  0 hours, 4 hours subsequently for maximum 14 days 
 
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)   30/07/2025 
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)
Modification(s)  
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  

METHODOLOGY

 

Patients presenting in Department of Critical Care Medicine with ARDS requiring mechanical ventilation will be recruited for the study. A written informed consent will be obtained from the patients’ caretaker. Participants will be enrolled into the study based on eligibility criteria.  

ARDS will be defined as per Berlin definition and patients will be classified as mild (200 mmHg

All the selected patients will undergo evaluation and general physical examination and appropriate routine baseline laboratory investigations. Patients who require mechanical ventilation will be included in the study further. Retrospectively patients will be grouped under survivors and non survivors for further analysis. 

ICU admission date will be considered as Day 0. The next date of ICU admission will be defined as Day 1. The following patient data will be recorded within 24 h after admission: Age, gender, Body mass index, medical history, SOFA and APACHE II score. 

On arrival in ICU arterial blood gas will be takenand PaO2/FiO2 ratio will be noted.  

Mechanical Ventilator settings:

At baseline, patients will be maintained deeply sedated and paralyzed, ventilated in volume control with a square wave form without any inspiratory pause, applying a tidal volume between 4 and 8 mL/kg of ideal body weight with a PEEP value set by the attending physician to ensure an arterial saturation between 88 and 95%. Ventilator settings will be readjusted on the basis of arterial blood gas values after 2 h of the first setting. Ventilator setup, adjustment andweaning will be performed at regular intervals of 12hrs and as necessary, based on the ARDS Clinical Network Mechanical Ventilation Protocol.(15)  

Baseline Endotracheal aspirate for gram staining and culture sensitivity will be sent on intubation.

Monitoring: 

Blood values of arterial pH, partial pressure of arterial oxygen (PaO2), partial pressure of arterial carbon dioxide (PaCO2), ratio of PaO2 and fraction of inspired oxygen (FiO2) i.e., PaO2/FIO2, will be recorded on arrival in ICU and at an interval of 12hours subsequently. Mechanical ventilator setting which includes VT (scaled to the predicted body weight [PBW]), RR, PEEP, respiratory system compliance, elastance, Plateau pressure and Driving Pressure (DP) will be recorded on intubation and then at an interval of 12 hours subsequently. Serial data will be recorded 12th hrly for a maximum of 14 days. The removal of the neuromuscular blocker or death will determine the end of the collection. 

 

Computed Tomography (CT) scan acquisition and analysis: Patients will be moved to the radiology department and a Multidetector row computed tomography (Philips Ingenuity 128 slice CT Scanner, Netherlands) from the thoracic inlet to the diaphragm will be performed. CT scan will be taken at full inspiration with PEEP of 5cm H2O sustained by a portable ventilator. All images will be reconstructed using standard reconstruction algorithms with a slice thickness of 1.0 mm and a reconstruction interval of 0.8 mm. The lung gas volume and amount of well-inflated tissue will be computed with an automated algorithm software (Philips Intellispace portal 11 solutions). Lung regions will be classified into 4 categories by CT attenuation densities: 1) hyperinflated, density between -1000 and -901 Hounsfield units (HU); 2) normally aerated, density between -900 and -501 HU; 3) poorly aerated, density between -500 and -101 HU; and 4) 

non-aerated, density between +100 and -100 HU. The volume of each lung region will be divided by predicted total lung capacity to correct for differences in physique among patients. 

 

Calculation of mechanical power:

Mechanical power will be obtained as the algebraic sum of three components as described earlier by Gattinoni et al. (5): 

1. Elastic–static power (J/min) =0.098 *VT*RR*PEEP.

2. Elastic–dynamic power (J/min)=0.098*VT*RR*0.5*DP.

3. Resistive power (J/min) = 0.098 * VT * RR * (Ppeak-Pplat).

 
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