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CTRI Number  CTRI/2025/10/096214 [Registered on: 21/10/2025] Trial Registered Prospectively
Last Modified On: 17/10/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Study to understand the changes in breathing pattern in diseased lung. 
Scientific Title of Study   A study to see the effect of incremental tidal volume on lung dynamics in ARDS 
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 Ruchi Gupta 
Designation  Consultant 
Affiliation  Holy Family Hospital 
Address  Department of Critical Care Medicine Holy Family Hospital New Delhi

South
DELHI
110025
India 
Phone  09910695602  
Fax    
Email  ruchi_gupta.mamc@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Ruchi Gupta 
Designation  Consultant 
Affiliation  Holy Family Hospital 
Address  Department of Critical Care Medicine Holy Family Hospital New Delhi

South
DELHI
110025
India 
Phone  09910695602  
Fax    
Email  ruchi_gupta.mamc@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Sumit Ray 
Designation  Medical Director and Head of Department 
Affiliation  Holy Family Hospital 
Address  Department of Critical Care Medicine Holy Family Hospital Okhla Road New Delhi

South
DELHI
110025
India 
Phone  09810614433  
Fax    
Email  drsray67@yahoo.co.in  
 
Source of Monetary or Material Support  
Holy Family Hospital Okhla Road New Delhi-110025 India 
 
Primary Sponsor  
Name  Dr Ruchi Gupta 
Address  Department of Critical Care Medicine Holy Family Hospital New Delhi-110025 India 
Type of Sponsor  Other [Self] 
 
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 Ruchi Gupta  Holy Family Hospital  Room no 63 Depart of critical care medicine Okhla Road New Delhi-110025 India
South
DELHI 		 09910695602

ruchi_gupta.mamc@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Holy Family Hospital Institute Ethical Committee  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 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  1.Patients aged 16 to 85 years old.
2.Diagnosis of ARDS Berlin Criteria for ARDS
Acute onset of hypoxemia
Bilateral pulmonary infiltrates on chest radiograph or CT scan.
Non-cardiogenic cause of pulmonary edema (no clinical signs of left atrial hypertension or heart failure).
3.Mechanical Ventilation-Patients who require invasive mechanical ventilation for more than 24 hours after ARDS diagnosis.
 
 
ExclusionCriteria 
Details  1.Pre-existing Chronic Respiratory Conditions:
Chronic obstructive pulmonary disease (COPD), emphysema, or interstitial lung disease.
Patients already on prone ventilation, pneumothorax, open lung, increase abdominal pressure.
2.Pregnancy:
Pregnant women or patients with an unknown pregnancy status.
Patients who are in extreme hemodynamic instability.
Patient required rescue strategy in prone position and ECMO first 24 hours.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To identify the effect of incremental tidal volume on driving pressure and lung compliance in Acute Respiratory Distress Syndrome (ARDS) patients.  day 0 and day 3 of initiating mechanical ventilation 
 
Secondary Outcome  
Outcome  TimePoints 
To identify the effect of changes in lung dynamics with incremental tidal volume on clinical outcomes: 28-day mortality, Ventilator-free days, ICU stay duration, hospital stay
 		 Discharge 
To identify the effect of changes in lung dynamics with incremental tidal volume with Severity: SOFA Score, PaO2/FiO2 ratio  days 0, 2, 4, 6, and 8.  
To identify the effect of changes in lung dynamics with incremental tidal volume on initiation of Rescue measures of ventilation like prone ventilation and ECMO support requirements.  duration of mechanical ventilation 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   03/11/2025 
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)   Not Applicable 
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   This is a prospective, single-center observational study conducted in an ICU setting to evaluate the effect of incremental tidal volume on lung mechanics in patients with Acute Respiratory Distress Syndrome (ARDS) who are on mechanical ventilation. Patients who are require invasive mechanical ventilation for more than 24 hrs. after ARDS diagnosis will be included. The study involves stepwise increases in tidal volume from 6 mL/kg to 10 mL/kg of predicted body weight (PBW), with continuous monitoring of plateau pressure, PEEP, driving pressure, and lung compliance. The procedure will be conducted on Day 1and repeated on Day 2,3,4 of mechanical ventilation. The aim is to understand how changes in tidal volume affect lung dynamics and to identify ventilatory thresholds that may impact patient safety and outcomes. The study follows strict safety protocols, and all interventions will be immediately stopped if clinical deterioration is observed. 
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