| 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
|
|
|
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
|
|
|
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
|
|
|
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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