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CTRI Number  CTRI/2025/01/079664 [Registered on: 28/01/2025] Trial Registered Prospectively
Last Modified On: 27/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   prospective 
Study Design  Other 
Public Title of Study   ARDS Phenotype and its association with RV dysfunction trajectory 
Scientific Title of Study   ARDS henotype and its association with Right ventricle dysfunction trajectory 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vasundhara Rakhi 
Designation  SENIOR RESIDENT 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCE NEW DELHI 
Address  Room no 5011,Anesthesiology office,Department of Anesthesiology, Pain medicine and Critical Care,AIIMS,Sri Aurobindo Marg,Ansari Nagar East New Delhi DELHI
Room no 5011,Anesthesiology office,Department of Anesthesiology, Pain medicine and Critical Care,AIIMS,Sri Aurobindo Marg,Ansari Nagar East New Delhi DELHI
New Delhi
DELHI
110049
India 
Phone  9958231321  
Fax    
Email  vasurakhichoudhary2708@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Souvik Maitra 
Designation  Additional Professor 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCE 
Address  Room no 5011,Anesthesiology office,Department of Anesthesiology, Pain medicine and Critical Care,AIIMS,Sri Aurobindo Marg,Ansari Nagar East New Delhi DELHI

New Delhi
DELHI
110029
India 
Phone  8146727891  
Fax    
Email  souvikmaitra@live.com  
 
Details of Contact Person
Public Query
 
Name  DrSOUVIK MAITRA 
Designation  Additional Professor 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCE 
Address  Room no 5011,Anesthesiology office,Department of Anesthesiology, Pain medicine and Critical Care,AIIMS,Sri Aurobindo Marg,Ansari Nagar East New Delhi DELHI

New Delhi
DELHI
110029
India 
Phone  8146727891  
Fax    
Email  souvikmaitra@live.com  
 
Source of Monetary or Material Support  
not required 
 
Primary Sponsor  
Name  All India Institute Of Medical Science 
Address  Room no 5011,Anesthesiology office,Department of Anesthesiology, Pain medicine and Critical Care,AIIMS,Sri Aurobindo Marg,Ansari Nagar East New Delhi DELHI 
Type of Sponsor  Research institution and hospital 
 
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 Vasundhara R  All India Institute of Medical Science New Delhi  Room no 5011,Anesthesiology office,Department of Anesthesiology, Pain medicine and Critical Care,AIIMS,Sri Aurobindo Marg,Ansari Nagar East New Delhi DELHI
New Delhi
DELHI 
9958231321

Vasurakhichoudhary2708@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
nstitute Ethics Committee For Post graduate Research, All India Institute Of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J989||Respiratory disorder, unspecified, (2) ICD-10 Condition: J80||Acute respiratory distress syndrome, (3) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Adult patients with ARDS as per Berlin definition10 and expanded definition.11
 
 
ExclusionCriteria 
Details 

1. Patients’ refusal
2. Patient who had cardiac arrest in the recent admission 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To know the association between ARDS phenotypes (hypo inflammatory vs hyper inflammatory and pulmonary vs extrapulmonary , focal vs diffuse)
pattern of RV dysfunction RV dilatation isolated, RV dilatation with RV-PA uncoupled, RV dilatation with RV function impaired ) with or without shock
 
Day 1,3,7 / Ventilation liberation
 
 
Secondary Outcome  
Outcome  TimePoints 
Association between ARDS phenotypes & RV dysfunction trajectory
Association between RV dysfunction pattern & clinical outcome
Association between respiratory mechanics & RV dysfunction Pattern
 
Day1,3,7/ Liberation from ventilation 
 
Target Sample Size   Total Sample Size="114"
Sample Size from India="114" 
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)   10/02/2025 
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="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

INCLUSION CRITERIA:

1.     Adult patients with ARDS as per Berlin definition10 and expanded definition.11

EXCLUSION CRITERIA

1.     Patients’ refusal

2.     Patient who had cardiac arrest in the recent admission

All patients in ED and ICU who meet the inclusion and exclusion criteria will be screened for enrolment within 24hr of diagnosis of ARDS. 2.5-MHz phased-array probe will be used for echocardiography. There will be no blinding of the clinical status to the investigator at the time of performance of Echocardiography.

The echocardiography will be performed by an experienced investigator who has conducted over 50 point-of-care echocardiograms, and it will be executed by a single observer.

 The assessments will take place at the time of the patient’s arrival in the ICU, as well as on Day 1, Day 3, Day 7, and at the time of liberation from the ventilator. The parameters evaluated during the echocardiography will include Left Ventricular End-Diastolic Area (LVEDA), Left Ventricular Ejection Fraction (LVEF), Tricuspid Annular Plane Systolic Excursion (TAPSE), TAPSE/Pulmonary Arterial Systolic Pressure (PASP), TAPSE/Tricuspid Regurgitant Velocity (TRV), Central Venous Pressure (CVP), Inferior Vena Cava (IVC) Diameter, IVC Distensibility, and Pulmonary Artery Acceleration Time. 

For each parameter, three measurements will be taken, and the average will be recorded. Additionally, the following ventilator parameters will be noted at the time of echocardiography: compliance, driving pressure, tidal volume, PEEP (Positive End-Expiratory Pressure), and respiratory rate. Basic laboratory parameters, including the P/F ratio (PaO2/FiO2), lactate levels, base excess, C-reactive protein (CRP), interleukin-6 (IL-6), interleukin-18 (IL-18), and the neutrophil-to-lymphocyte ratio (NLR), will also be assessed. Finally, the APACHE (Acute Physiology and Chronic Health Evaluation) and SOFA (Sequential Organ Failure Assessment) scores will be calculated to evaluate the patients’ conditions comprehensively.

 

 
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