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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: J22||Unspecified acute lower respiratory infection, |
|
Intervention / Comparator Agent
|
|
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 |