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CTRI Number  CTRI/2020/10/028416 [Registered on: 15/10/2020] Trial Registered Prospectively
Last Modified On: 14/10/2020
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   A Study on Clinical Profile of Acute Respiratory Distress Syndrome (ARDS) in a Tertiary Care Hospital in India. 
Scientific Title of Study   Clinical Profile of ARDS(Acute Respiratory Distress Syndrome)in a Tertiary Care Hospital in India. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Bharat Kumar R 
Designation  Junior Resident -Department of General Medicine 
Affiliation  Kasturba Medical College 
Address  Department of General Medicine- Kasturba Medical College- Manipal

Udupi
KARNATAKA
576104
India 
Phone  7760092548  
Fax    
Email  bharathrk95@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Raviraja V Acharya 
Designation  Professor and HOD-Department of General Medicine 
Affiliation  Kasturba Medical College 
Address  Room-206, OPD block ,Department of General Medicine- Kasturba Medical College- Manipal

Udupi
KARNATAKA
576104
India 
Phone  9845471000  
Fax    
Email  ravi.katte@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Bharat Kumar R 
Designation  Junior Resident -Department of General Medicine 
Affiliation  Kasturba Medical College 
Address  Department of General Medicine- Kasturba Medical College- Manipal

Udupi
KARNATAKA
576104
India 
Phone  7760092548  
Fax    
Email  bharathrk95@gmail.com  
 
Source of Monetary or Material Support  
Self Funded Study/Material support by Institution-Kasturba Medical College Manipal. 
 
Primary Sponsor  
Name  SelfDr Bharat Kumar R  
Address  Department Of General Medicine KMC Manipal, udupi district. Pincode 576104 
Type of Sponsor  Other [Self Funded Study] 
 
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 
Bharat Kumar R  Kasturba medical college-manipal  # Room 17 ,2nd floor, Department of general medicine Kasturba medical college Manipal.
Udupi
KARNATAKA 
7760092548

bharathrk95@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba medical college and hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J22||Unspecified acute lower respiratory infection,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1) Age>18 years
2) Onset<1 week
3) Chest xray/CTscan - shows B/L opacities not fully explained by cardiac failure/pleural effusion/lung collapse. ECHOCARDIOGRAPHY- shows no evidence of cardiac failure.
4) PaO2/FIO2<300 
 
ExclusionCriteria 
Details  1) Not fulfilling the above given criteria.
2) Not consenting to be included in the study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the outcome of people diagnosed with ARDS by the following measures.
A) No. of days in hospital B)No. of days in ICU
C) OveraII mortality , Specific mortality rates in patients with comorbid conditions. 
Till the end of current hospital admission.
 
 
Secondary Outcome  
Outcome  TimePoints 
Early predictors of Mortality and the potential to improve standard of care in the management of ARDS  Till the end of study period 
 
Target Sample Size   Total Sample Size="400"
Sample Size from India="400" 
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)   16/10/2020 
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   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
1)  Title of the project : A Study on Clinical Profile of ARDS in a Tertiary Care Hospital in India.
2)  Type of Study : (Prospective / Observational/Single center study
3)  AIM- To Study the Clinical profile of ARDS in a tertiary care hospital in India
4)  OBJECTIVES- To determine the incidence of mortality due to different causes of ARDS To Study Early Predictors of mortality ARDS
5)  Justification for study (whether of national significance with rationale):
     ARDS is a Major problem in General medicine and Critical Care and there are very few studies on ARDS is seen in the Indian population


6)Detailed Procedure of the study- Inclusion/Exclusion criteria-As mentioned under the given heading.

 Inpatients of Major ICU’s in Kasturba Hospital will be screened to find out whether they fulfill the inclusion criteria of the study.
a) Patients fulfilling the criteria will be noted down.
b) Consent will be taken from the family members of patients to enroll into the study.
) A Set Proforma will be given to the patient attenders presentation of the patient
d) Vitals and the relevant information will be filled out by the principal investigator at the time. 
e) Investigation chart and relevart information will be noted down by the principal investigator
I) Apache 2 score will be calculated at the time of presentation
g) Serial Monitoring of SOFA’s score and Murrav’• Lung Injury Score will be done.
h) The patients would recieve the appropriate standard of care in hospital.
i) Clinical profile will be made for each patient under the study and it will include the demography details along with details of the suspected etiology , the details of the suspected source of primary infection , the organism that the cultures of the patient are growing and its sensitivity pattern

7) Outcome measures such as 
  A) No. of days in hospital
  B)No. of days in ICU
  C) OveraII mortality , Specñic mortality rates in patients with comorbid conditions will be calculated.

8) Early predictors of Mortality and the potential to improve standard of care in the management of ARDS will be analysed.
9)  Potential risks and benefits :
    Risks are Minimal.
    Benefits- Early predictors of mortality will be studied and will improve the standard of care subsequently.
9) Ethical considerations and methods to address issues :
     IEC Clearance, Informed consent will be Obtained from the participant and use of indirect identifiers to ensure confidentialilty.


10)Budget/Sponsor- Not applicable-Self Funded Study 
 
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