An observational study on Acute Respiratory Distress Syndrome (ARDS) in India

Recruiting

Conditions: Acute Respiratory distress Syndrome

Registration Number: CTRI/2014/08/004880

Lead Sponsor: Fulbright Scholarship

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 300

Inclusion Criteria

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.

Exclusion Criteria

1.- The following ICUs will be excluded: a) Pediatric ICU b) Post-op Anesthesia Recovery Room 2.- Patient less than 18 yr.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Discharge from the ICU and/or death	24 hours after successful extubation and 28 days after enrollment in the study

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (6): Apollo Hospitals Chennai
🇮🇳
Chennai, TAMIL NADU, India
Max Super Speciality Hospital
🇮🇳
Delhi, DELHI, India
Medanta The Medcity
🇮🇳
Gurgaon, HARYANA, India
PD Hinduja National Hospital
🇮🇳
Mumbai, MAHARASHTRA, India
Sri Venkateswara Institute of Medical Sciences
🇮🇳
Chittoor, ANDHRA PRADESH, India
Tata Memorial Hospital
🇮🇳
Mumbai, MAHARASHTRA, India
Apollo Hospitals Chennai
🇮🇳Chennai, TAMIL NADU, India
Dr N Ramakrishnan
Principal investigator
04428286517
research@icuconsultants.com