| CTRI Number |
CTRI/2024/05/067473 [Registered on: 16/05/2024] Trial Registered Prospectively |
| Last Modified On: |
15/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Usg guided CPR] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the impact of ultrasound guided chest compressions when compared to conventional chest compressions |
|
Scientific Title of Study
|
To study the impact of ultrasound guided chest compressions when compared to conventional chest compressions in cardiac arrest outcomes in patients with cardiac arrest |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanjeev Kumar Bhoi |
| Designation |
Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Office
Department of Emergency Medicine
AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
8527050391 |
| Fax |
|
| Email |
Sanjeevbhoi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sanjeev Bhoi |
| Designation |
Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Department Office
Department of Emergency Medicine
AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
8527050391 |
| Fax |
|
| Email |
sanjeevbhoi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anuvinda pg |
| Designation |
Junior Resident |
| Affiliation |
AIIMS New Delhi |
| Address |
Department Office
Department of Emergency Medicine
AIIMS New Delhi
New Delhi
DELHI
110029
India |
| Phone |
8826347718 |
| Fax |
|
| Email |
anuvindapgpg@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS New Delhi |
| Address |
AIIMS New Delhi
110029 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Anuvinda PG |
All India Institute Of Medical Sciences New Delhi |
Adult Emergency
Department of Emergency Medicine
AIIMS new delhi
Ansari Nagar east
New delhi
India
New Delhi
DELHI |
8826347718
anuvindapgpg@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee All India institute of medical sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I469||Cardiac arrest, cause unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional cpr |
When a patient comes to emergency department in cardiac arrest or in hospital cardiac arrest CPR will be started according to the BLS protocol.In this arm no change in the location of CPR occurs after 5 cycles of CPR .CPR continues at the lower part of sternum only. |
| Intervention |
Ultrasound guided CPR |
When a patient comes to emergency department in cardiac arrest or in hospital cardiac arrest CPR is started according to the BLS protocol.During the first 5 cycles of CPR and optimal area of compression is identified in parasternal short axis view and compression will be based off of this point after 5 cycles of CPR.This is the intervention .
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Any patient above the age of 18 presenting in cardiac arrest to emergency department |
|
| ExclusionCriteria |
| Details |
Exclusion criteria
1.Less than 18 years
2. showing signs of irreversible cardiac arrest at presentation or where cardiopulmonary resuscitation cannot be done-
Decapitation
Decomposition
Post mortem lividity
Post mortem rigidity
Burned beyond recognition
Unsafe scene
Complete crush injury of thorax
3.Patients signed as Do Not Intubate-Do Not Resuscitate
4. Pregnant females
Patients in whom the area of maxima compression could not be identified dur echocardiography |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Difference in End tidal Carbon dioxide |
After 20 minutes of conventional Cardiopulmonary resuscitation
Cerebral performance score at 21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Difference in
1.Return of spontaneous circulation
2.Survival to hospital admission rate
3.Survival to discharge rate
4. Neurological outcome in terms of cerebral performance score at 1 month. |
20 minutes |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
26/05/2024 |
| 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="6"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (NIL).
- For how long will this data be available start date provided 15-07-2026 and end date provided 15-07-2029?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
To study the usefulness of ultrasound identified area of maximum compression to improve the patient hemodynamics and post cardiac arrest outcomes. |