| CTRI Number |
CTRI/2025/10/096341 [Registered on: 22/10/2025] Trial Registered Prospectively |
| Last Modified On: |
01/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Predicting outcomes in patients at risk for acute respiratory distress using right heart function status. |
|
Scientific Title of Study
|
Prevalence of Right Ventricular dysfunction subphenotypes and their utility as predictor of outcomes in patients of ARFA (At risk for ARDS) on invasive mechanical ventilation |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
JERUSHA ANN MATHEWS |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
KASTURBA MEDICAL COLLEGE , MANIPAL |
| Address |
DEPARTMENT OF GENERAL MEDICINE,
KASTURBA MEDICAL COLLEGE,
MAHE , MANIPAL.
Udupi
KARNATAKA
576104
India |
| Phone |
9740225485 |
| Fax |
|
| Email |
jerushagms@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
VASUDEVA ACHARYA |
| Designation |
HEAD OF UNIT |
| Affiliation |
KASTURBA MEDICAL COLLEGE , MANIPAL |
| Address |
DEPARTMENT OF GENERAL MEDICINE,
KASTURBA MEDICAL COLLEGE,
MAHE , MANIPAL.
Udupi
KARNATAKA
576104
India |
| Phone |
9740225485 |
| Fax |
|
| Email |
acharya.vasudeva@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
VASUDEVA ACHARYA |
| Designation |
HEAD OF UNIT |
| Affiliation |
KASTURBA MEDICAL COLLEGE , MANIPAL |
| Address |
DEPARTMENT OF GENERAL MEDICINE,
KASTURBA MEDICAL COLLEGE,
MAHE , MANIPAL.
Udupi
KARNATAKA
576104
India |
| Phone |
9740225485 |
| Fax |
|
| Email |
acharya.vasudeva@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
JERUSHA MATHEWS |
| Address |
KASTURBA MEDICAL COLLEGE, MANIPAL |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| JERUSHA ANN MATHEWS |
KASTURBA MEDICAL COLLEGE MANIPAL |
GENERAL MEDICINE DEPARTMENT
Udupi
KARNATAKA |
9740225485
jerushagms@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institiutional Ethics Committee - 2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J988||Other specified respiratory disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients more than 18 years on invasive mechanical ventilation admitted in Kasturba hospital
Patients in ARFA (i.e., not entirely fulfilling the diagnostic criteria of ARDS)
Presence of any of the following radiological features(C-X-ray, Lung ultrasound,CT)
1.Alveolar infiltrates (can be hemorrhagic)
2.Interstitial infiltrates
3. Atelectasis
4.Consolidation
5.Ground glass opacities
6.Air bronchogram in lung ultrasound
Respiratory Symptoms (at least one)
New or increased cough
New or increased sputum production
Dyspnea
Pleuritic chest pain
Other Signs or Findings (at least one)
Abnormal lung sounds (rhonchi or rales)
Fever (more than or equal to 100.4 °F)
Leukocytosis or unexplained bandemia (above normal limits for laboratory)
Hypoxia (less than 90%)
|
|
| ExclusionCriteria |
| Details |
1)ARFA patients on NIV
2)Patients not recruited within first 24 hours of IMV
3)Patients already having pre-existing Pulmonary Artery Hypertension
4)Patients having pre-existing EF of less than 40 per cent
5)Patients on any biological agent, prednisone equivalent of more than 10 mg per day and 700 mg cumulative dose , antiproliferative agents and B or T cell depletion medications
6)Patients having malignancies
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Demographic , biochemical and Echo/USG data will be collected within 72 hours of admission which is part of standard of care.
Hence the investigator will only collect the reports.
Outcome will assessed based on duration of Icu stay, use of vasopressors and mechanical
ventilation.
Outcomes will be analyzed at the time of discharge – Improved/Expired |
24 HOURS , 72 HOURS
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="174"
Sample Size from India="174"
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)
|
01/11/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Prevalence of Right Ventricular dysfunction subphenotypes and their utility as
a predictor of outcomes in patients of ARFA (At risk for ARDS) on invasive mechanical ventilation
AIM - To identify RV dysfunction subphenotypes and to use it as a predictor of outcome in patients of
ARFA on IMV
OBJECTIVES-
1.To identify prevalence of the sub-phenotypes of RV dysfunction based on trans thoracic
echocardiography namely :
a)RV dilation with preserved function – RV LVEDA ratio more than 0.6, RV basal diameter more than equal to 41 mm and
TAPSE more than equal to 18 mm,
b)RV dilation with impaired function – RV LVEDA ratio more than 0.6 ,RV basal diameter more than equal to 41 mm and
TAPSE less than 18 mm
2.Utility of categorising RV dysfunction sub-phenotypes as a predictor of outcome ,namely 28 day
mortality, days of ICU stay, days of hospital stay.
3.Assessing the fluid status in the different phenotypes based on IVC diameter and cumulative 48
hours intake output charts in the ICU
HYPOTHESIS-
The prevalence of Subphenotype 2 of RV dysfunction in patients with ARFA is similar to patients with
ARDS (13 percent)
Justification for study - Why ARFA?
Burden of illness-
Recently, incidence ranges for acute respiratory failure , acute respiratory distress syndrome (ARDS)
in adults were reported and found to be 77.6–88.6 and 12.6–28.0 cases out of 100 000 population per year,
respectively. Mortality rates of approximately 40 per cent were reported for patients with acute respiratory
failure, and similar or slightly lower rates for those with ARDS.
Why the need for identifying the different RV subphenotypes ?
In patients with compensated RV dilation - reducing the RV afterload and venous congestion is
necessary to mitigate progression to decompensated RV failure.
However in patients where RV systolic function and cardiac output are compromised , the afore
mentioned therapies would be inadequate , rather trials of inotrope/inodilator therapies or mechanical
circulatory support would be required.
Hence identifying the different RV subphenotypes aids in better patient care and management
Departments involved: Medicine department , Critical Care Medicine department , Kasturba
Hospital, Manipal
Study period: Post IEC approval to April 2027
Sample size: Based on the prevalence of sub-phenotype 2 ( RV dilated with impaired RV function)
in ARDS being 13per cent , and expecting the same to be in patients with ARFA, the prevalence formula was
used for the calculation of the sample size)
N is 174 patients of ARFA on IMV
INCLUSION CRITERIA :
Patients more than 18 years on invasive mechanical ventilation admitted in Kasturba hospital
Patients in ARFA (i.e., not entirely fulfilling the diagnostic criteria of ARDS)
Presence of any of the following radiological features(C-X-ray, Lung ultrasound,CT)
1.Alveolar infiltrates (can be hemorrhagic)
2.Interstitial infiltrates
3. Atelectasis
4.Consolidation
5.Ground glass opacities
6.Air bronchogram in lung ultrasound
Respiratory Symptoms (at least one)
New or increased cough
New or increased sputum production
Dyspnea
Pleuritic chest pain
Other Signs or Findings (at least one)
Abnormal lung sounds (rhonchi or rales)
Fever (more than equal to 100.4 F)
Leukocytosis or unexplained bandemia (above normal limits for laboratory)
Hypoxia (less than 90per cent)
EXCLUSION CRITERIA
1)ARFA patients on NIV
2)Patients not recruited within first 24 hours of IMV
3)Patients already having pre-existing Pulmonary Artery Hypertension
4)Patients having pre-existing EF of less than 40 per cent
5)Patients on any biological agent, prednisone equivalent of more than 10 mg/day and 700 mg
cumulative dose , antiproliferative agents and B ,Tcell depletion medications
6)Patients having malignancies
-Patient will be selected based on the above mentioned inclusion/exclusion criteria and are
recruited into the study after taking informed consent
-Demographic , biochemical and Echo/USG data will be collected within 72 hours of admission
which is part of standard of care.Hence the investigator will only collect the reports.
- Outcome will assessed based on duration of Icu stay, use of vasopressors and mechanical
ventilation.
- Outcomes will be analyzed at the time of discharge – Improved/Expired
- Outcome measures: Outcome will assessed based on duration of Icu stay, use of
vasopressors and mechanical ventilation.
|