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CTRI Number  CTRI/2025/06/088191 [Registered on: 04/06/2025] Trial Registered Prospectively
Last Modified On: 03/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Descriptive 
Study Design  Other 
Public Title of Study   A observational study of symptoms and patterns of Acute Respiratory Distress Syndrome 
Scientific Title of Study   Clinical profile of acute respiratory distress syndrome in patients admitted to Acharya Vinoba Bhave Rural Hospital 
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 Mummaneni Rashmika 
Designation  Junior Resident in MD Respiratory Medicine 
Affiliation  Datta Meghe Institution of Higher Education and Research 
Address  Dept of Respiratory Medicine , Acharya vinoba bhave rural hospital,Sawangi (meghe)

Wardha
MAHARASHTRA
442001
India 
Phone  9494957969  
Fax    
Email  rashmika.m4u@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ulhas Jadhav 
Designation  Professor in Respiratory Medicine  
Affiliation  Datta Meghe Institution of Higher Education and Research 
Address  Dept of Respiratory Medicine , Acharya vinoba bhave rural hospital,Sawangi (meghe)

Wardha
MAHARASHTRA
442002
India 
Phone  9970819099  
Fax    
Email  dr.ulhasjadhav@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ulhas Jadhav 
Designation  Professor in Respiratory Medicine  
Affiliation  Datta Meghe Institution of Higher Education and Research 
Address  Dept of Respiratory Medicine , Acharya vinoba bhave rural hospital,Sawangi (meghe)


MAHARASHTRA
442002
India 
Phone  9970819099  
Fax    
Email  dr.ulhasjadhav@gmail.com  
 
Source of Monetary or Material Support  
Datta Meghe Institute of Higher Education and Research, Acharya Vinoba Bhave Rural Hospital, Sawangi (Meghe), Wardha- 442107, Maharashtra, India. 
 
Primary Sponsor  
Name  Datta Meghe Institute of Higher Education and Research 
Address  Datta Meghe Institute of Higher Education and Research,Sawangi (Meghe), Wardha- 442107, Maharashtra, India. 
Type of Sponsor  Private 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 Mummaneni Rashmika  Datta Meghe Institution of Higher Education and Research  Dept of Respiratory Medicine , Acharya vinoba bhave rural hospital,Sawangi (meghe)
Wardha
MAHARASHTRA 
09494957969

rashmika.m4u@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Commitee .Datta Meghe Institute of Higher Education and Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J00-J99||Diseases of the respiratory system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients fulfilling Berlins criteria  
 
ExclusionCriteria 
Details  1.Patients age less than 18 years

2.patients or patient relatives not willing to give consent

3.patients with heart failure 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Mortality rate
2.ICU length of stay
3.Duration of mechanical ventilation 
1.Until hospital discharge
2.Until extubation
3.Discharge from ICU 
 
Secondary Outcome  
Outcome  TimePoints 
1.Oxygenation Improvement (PaO2/FiO2 Ratio)
2.Organ Dysfunction 
1.Admission to ICU,48 hours,7 days,discharge from ICU
2.Daily assessment 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   16/06/2025 
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="4"
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  

Introduction

Acute respiratory distress syndrome (ARDS) is a lung injury causing significant morbidity and mortality in critically ill patients. The cause can be directly or indirectly caused by factors such as pneumonia, toxic gas inhalation, sepsis, or trauma. The etiology of ARDS may differ in India due to higher incidence of tropical infectious diseases. Early diagnosis can be made by physicians with a high index of suspicion and a thorough understanding of the disease’s natural history. Careful assessment of oxygenation, ventilation, and acid base status can help determine the need for intervention. The syndrome can be triggered by various factors, including pulmonary or extrapulmonary sepsis, aspiration, trauma, blood product transfusion, or pancreatitis. Non-invasive ventilation (NIV) in ARDS is contentious, with no large definitive studies. Proper treatment of precipitating infections is crucial for survival.

 The Berlin Definition is a set of diagnostic criteria for Acute Respiratory Distress Syndrome (ARDS) that was proposed in 2012 as an update to the older American-European Consensus Conference (AECC) criteria. The Berlin Definition aimed to provide more specific and standardized criteria for the diagnosis of ARDS. Here are the key components of the Berlin criteria for ARDS:

Timing:

ARDS symptoms start within a week of a known problem or worsening breathing.

Chest Imaging:

X-ray or CT scan shows cloudy areas in both lungs.

Cause of Breathing Trouble:

Breathing trouble is not solely due to heart issues or too much fluid.

Oxygen Levels:

Oxygen levels in the blood are measured by the PaO2/FiO2 ratio.

 ARDS is classified as mild, moderate, or severe based on this ratio.

Aims and objectives

Aims:

To study clinical profile of ARDS.

Objectives

1.To study etiological and clinical profile of ARDS.

2.To study clinical characteristics , diagnostics and therapeutic modalities in ARDS.

3.To study outcome in patients of ARDS.

Materials and Methods

STUDY DESIGN- PROSPECTIVE OBSERVATIONAL

STUDY DURATION: JANUARY 2024- DECEMBER 2025

STUDY POPULATION : PATIENT WITH ARDS IN AVBRH

INCLUSION CRITERIA

1.Patients fulfilling berlin’s definition of ARDS

EXCLUSION CRITERIA

1.Patients with age <18years

2.Patients or pt relatives not willing to give consent

3. Patients with heart failure

INVESTIGATIONS:

Complete Blood Count, Lipid profile, Thyroid profile, Blood sugar levels, Kidney and liver function tests, Urine routine and microscopy, Chest xray, Ecg, 2D Echo, HRCT Thorax

Clinical assessment

Blood Pressure (BP), Pulse Rate (PR), Respiratory Rate (RR), Saturation, Temperature

Medical history documentation (Hypertension, Diabetes Mellitus, chronic illnesses, smoking/alcohol history)

Statistical Analysis

 Continuous variables: Expressed as Mean ‡ Standard Deviation, compared using unpaired t-test or ANOVA.

 Categorical variables: Expressed as frequencies and percentages, analyzed using chi-square tests.

Correlation analysis: Performed using Pearson’s or Spearman’s correlation coefficients.

Statistical software: SPSS version 27.0

Significance level: p < 0.05 considered statistically significant.



Ethical Considerations

Informed Consent: Patients will be informed about study procedures in their native language. Written consent will be obtained.

Confidentiality: Patient data will be anonymized and stored securely in a password-protected database.

Adherence to Guidelines: The study follows institutional ethical committee guidelines and Good Clinical Practice (GCP) standards.

 


 
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