A Study on Clinical Profile of Acute Respiratory Distress Syndrome (ARDS) in a Tertiary Care Hospital in India.
- Conditions
- Unspecified acute lower respiratory infection,
- Registration Number
- CTRI/2020/10/028416
- Lead Sponsor
- SelfDr Bharat Kumar R
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 400
-
- 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.
-
- Not fulfilling the above given criteria.
-
- Not consenting to be included in the study.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To study the outcome of people diagnosed with ARDS by the following measures. Till the end of current hospital admission. A) No. of days in hospital B)No. of days in ICU Till the end of current hospital admission. C) OveraII mortality , Specific mortality rates in patients with comorbid conditions. Till the end of current hospital admission.
- Secondary Outcome Measures
Name Time Method Early predictors of Mortality and the potential to improve standard of care in the management of ARDS Till the end of study period
Trial Locations
- Locations (1)
Kasturba medical college-manipal
🇮🇳Udupi, KARNATAKA, India
Kasturba medical college-manipal🇮🇳Udupi, KARNATAKA, IndiaBharat Kumar RPrincipal investigator7760092548bharathrk95@gmail.com