| CTRI Number |
CTRI/2024/07/070827 [Registered on: 18/07/2024] Trial Registered Prospectively |
| Last Modified On: |
18/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
diagnostic study |
| Study Design |
Other |
|
Public Title of Study
|
To compare clinical and radiological diagnosis using scan in a patient coming with acute onset dyspnea |
|
Scientific Title of Study
|
A Comparative study of the clinical diagnosis with radiological diagnosis using BRIPPED scan and to assess if BRIPPED scan is able to identify acute life-threatening condition in a patient presenting to the emergency department with acute onset dyspnea |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
M MEENAL |
| Designation |
Assistant Professor |
| Affiliation |
BHAARATH MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of Anesthesiology
Bhaarath Medical College and Hospital 173,Agaram main road, Selaiyur
Chennai
Department of Anaesthesiology Bhaarath Medical College and Hospital 173,Agaram main road,selaiyur
chennai
Kancheepuram
TAMIL NADU
600072
India |
| Phone |
9790749822 |
| Fax |
|
| Email |
meenal.biotech@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
M MEENAL |
| Designation |
Assistant Professor |
| Affiliation |
BHAARATH MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of Anaesthesiology
Bhaarath Medical College and Hospital 173,Agaram main road
Selaiyur
Chennai
Department of Anesthesiology Bhaarath Medical College and Hospital 173,Agaram main road,Selaiyur
Chennai
Kancheepuram
TAMIL NADU
600073
India |
| Phone |
9790749822 |
| Fax |
|
| Email |
meenal.biotech@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
M MEENAL |
| Designation |
Assistant Professor |
| Affiliation |
BHAARATH MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of Anesthesiology
Bhaarath Medical College and Hospital 173,Agaram main road
Selaiyur
Chennai
Department of Anesthesiology Bhaarath Medical College and Hospital 173,Agaram main road,Selaiyur
Chennai
Kancheepuram
TAMIL NADU
600073
India |
| Phone |
9790749822 |
| Fax |
|
| Email |
meenal.biotech@gmail.com |
|
|
Source of Monetary or Material Support
|
| M.Meenal
Bhaarath Medical College and
Hospital
173,Agaram main road,Selaiyur
Chennai 600073
|
|
|
Primary Sponsor
|
| Name |
Dr M MEENAL |
| Address |
Bhaarath Medical College and Hospital 173 Agaram Main Road
Selaiyur,Chennai 600073 |
| Type of Sponsor |
Other [] |
|
|
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 |
| DR M MEENAL |
Bhaarath Medical College and Hospital |
Department of Anesthesiology Bhaarath Medical College and Hospital 173,Agaram Main
Road ,Selaiyur Chennai 600073
TAMBARAM CHENNAI
Kancheepuram
TAMIL NADU |
9790749822
meenal.biotech@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bhaarath Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J810||Acute pulmonary edema, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
No intervention |
No intervention |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
patient more than 18 yrs with acte onset dyspnea with respiratory rate more than 20 breaths per minute,saturation less than 95%at room air,use of accessory muscles of respiration |
|
| ExclusionCriteria |
| Details |
primary mental disability
Thoraco-abdominal trauma
Known case of patient with singular history of asthma
Pregnant patient
Lactating patient |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To document the feasibility and time taken for doing BRIPPED scan in a patient with acute onset dyspnea. |
within 15 minutes of patient arrival |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess if BRIPPED scan improves primary assessment by identifying any life threatening condition |
within 1 hr of patient arrival |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
01/08/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To assess if BRIPPED scan improves primary assessment by identifying any life threatening condition To compare the clinical diagnosis made by emergency physician in ER and radiological diagnosis using BRIPPED scan. |