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CTRI Number  CTRI/2014/08/004880 [Registered on: 14/08/2014] Trial Registered Retrospectively
Last Modified On: 14/08/2014
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   An observational study on Acute Respiratory Distress Syndrome (ARDS) in India 
Scientific Title of Study   Snap shot of Acute Respiratory Distress Syndrome (ARDS) 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  Dr Kalpalatha Guntupalli 
Designation  Professor and Chief, Pulmonary, Critical Care and Sleep 
Affiliation  Mediciti Institute of Medical Sciences  
Address  Mediciti Institute of Medical Sciences, Hyderabad Hyderabad ANDHRA PRADESH 501401 India

Hyderabad
ANDHRA PRADESH
501401
India 
Phone    
Fax    
Email  guntupalli00@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kalpalatha Guntupalli 
Designation  Professor and Chief 
Affiliation  Pulmonary Critical Care and Sleep 
Address  Mediciti Institute of Medical Sciences, Hyderabad Hyderabad ANDHRA PRADESH 501401 India

Hyderabad
ANDHRA PRADESH
501401
India 
Phone    
Fax    
Email  guntupalli00@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Kalpalatha Guntupalli 
Designation  Professor and Chief 
Affiliation  Pulmonary Critical Care and Sleep 
Address  Mediciti Institute of Medical Sciences, Hyderabad Hyderabad ANDHRA PRADESH 501401 India

Hyderabad
ANDHRA PRADESH
501401
India 
Phone    
Fax    
Email  guntupalli00@gmail.com  
 
Source of Monetary or Material Support  
Fulbright Scholarship 
 
Primary Sponsor  
Name  Fulbright Scholarship 
Address  United States-India Educational Foundation 12 Hailey Road New Delhi 110 001 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr N Ramakrishnan  Apollo Hospitals Chennai  Department of Critical Care, 2nd floor, 21 Greams Lane Chennai 600 006 Chennai TAMIL NADU
Chennai
TAMIL NADU 
04428286517
04428295466
research@icuconsultants.com 
Dr Y P Singh  Max Super Speciality Hospital  Department of Critical care, Max Super speciality hospital, 108-A, Indraprastha Ext, Patparganj, Delhi-110092
New Delhi
DELHI 
911143033333
911122235563
Yogendra.Singh2@maxhealthcare.com 
Dr Yatin Mehta  Medanta The Medcity  Department of Critical Care Medanta the medcity Sector 38, Gurgaon Haryana
Gurgaon
HARYANA 
911244141414
911244834111
Yatin.Mehta@Medanta.org 
Dr F N Kapadia  PD Hinduja National Hospital  Department of Critical Care, Veer Savarkar Marg, Mahim, Mumbai 400016
Mumbai
MAHARASHTRA 
912224452222
912224447490
fnkapadia@gmail.com 
Dr Alladi Mohan  Sri Venkateswara Institute of Medical Sciences  Department of Medicine, SVIMS, Alipiri Road, Tirupathi, Chittoor district, Andhra Pradesh
Chittoor
ANDHRA PRADESH 
918772287152
91-877-2286803
alladimohan@gmail.com 
Dr J V Divatia  Tata Memorial Hospital  Department of Anaesthesia, Critical Care and Pain, Tata Memorial Hospital, Parel, Mumbai - 400012
Mumbai
MAHARASHTRA 
912224177000
912224146937
jdivatia@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Apollo Hospital Ethics Committee  Approved 
Max Super speciality Institutional Ethics Committee  Approved 
Medanta Independent Ethics Committee  Approved 
PD Hinduja Institutional Review Board  Approved 
SVIMS Institutional Ethics Committee  Approved 
Tata Memorial Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Acute Respiratory distress Syndrome,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1.- Patients who are admitted to the ICU and are diagnosed with
ARDS using Berlin criteria
2.- Patients who are admitted to the ICU with a diagnosis of ARDS
will be included weather they are managed with invasive or non
invasive ventilation. We suspect it will be a rare patient that can be
managed by non invasive ventilation.
3.- This study will be conducted in Intensive Care Units (MICU, CCU,
SICU, etc) that are willing to participate in the study. There will be
one site principal investigator who will be responsible for entering the
data on all the ICUs in a hospital.
4.- Patients in whom mechanical ventilation was started outside the
study ICU at the same Institution and/or a different Institution,
including Emergency Room, Operating Room (OR), and were then
transferred to the ICU with the diagnosis of ARDS are also included. 
 
ExclusionCriteria 
Details  1.- The following ICUs will be excluded:
a) Pediatric ICU
b) Post-op Anesthesia Recovery Room
2.- Patient less than 18 yr 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Discharge from the ICU and/or death  24 hours after successful extubation and 28 days after enrollment in the study 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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)   15/05/2013 
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)  Open to Recruitment 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Acute Respiratory Distress Syndrome is a catastrophic acute respiratory illness: ARDS is a
serious acute respiratory illness that can affect even previously healthy individuals. This condition
has varied etiologies, notably pneumonia, sepsis, aspiration and trauma. While common etiologies
exist in the countries world wide, there is a regional difference influenced by the socio economic
conditions, disease prevalence and access to care. . Examples include cases of ARDS seen in
Malaria, Dengue or Tuberculosis in India are not prevalent in other countries. Recently the
definition of ARDS has been revised. An important new component of the new Berlin definition of
ARDS is the identification of a predisposing condition, and the development of new or worsening
respiratory symptoms within seven days of that insult. This timeframe gives a clearly specified
window following the onset of a predisposing condition during which interventions to prevent
development of ARDS may be administered. 

Critical Care is a new specialty worldwide. It is growing and is now an established field in India. One
of the objectives of this proposal is to bring together likeminded committed intensivists and
institutions to focus on ARDS. We begin with gathering a snapshot of a well-defined entity with a
significant mortality to further characterize it in India. Although critical illness seems same for the
suffering patient, its etiology and effect on the family seem to be more regionally influenced.

 
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