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
|
|
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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Acute Respiratory distress Syndrome, |
|
Intervention / Comparator Agent
|
|
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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