| CTRI Number |
CTRI/2024/10/075484 [Registered on: 18/10/2024] Trial Registered Prospectively |
| Last Modified On: |
17/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Other (Specify) [CARDIAC ARREST] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the differences in outcome between a preset positive pressure and standard(zero positive pressure) during Chest compressions in patients with cardiac arrest |
|
Scientific Title of Study
|
PEEP VS ZEEP In cardiopulmonary resuscitation A randomised controlled pilot trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashwin Kumar |
| Designation |
Junior Resident |
| Affiliation |
AIIMS, New Delhi |
| Address |
AIIMS Emergency Office, AIIMS, New Delhi-110029
New Delhi
DELHI
110029
India |
| Phone |
7092657423 |
| Fax |
|
| Email |
meashwin2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayer Jamshed |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
AIIMS Emergency Office, AIIMS, New Delhi-110029
New Delhi
DELHI
110029
India |
| Phone |
9990345682 |
| Fax |
|
| Email |
jamshednayer@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashwin Kumar |
| Designation |
Junior Resident |
| Affiliation |
AIIMS, New Delhi |
| Address |
AIIMS Emergency Office, AIIMS, New Delhi-110029
New Delhi
DELHI
110029
India |
| Phone |
7092657423 |
| Fax |
|
| Email |
meashwin2000@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS emergency office,AIIMS, New Delhi-110029, India |
|
|
Primary Sponsor
|
| Name |
Department Of Emergency Medicine |
| Address |
AIIMS, New Delhi-110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Ashwin Kumar |
AIIMS NEW DELHI |
AIIMS Emergency office,AIIMS,New Delhi-110029, Ansari Nagar,India
New Delhi
DELHI |
7092657423
meashwin2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE FOR BIOMEDICAL AND HEALTH RESEARCH |
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 |
| Intervention |
PEEP of 5cm of water |
in patients presenting with cardiac arrest and randomised to the intervention group, CPR will be given with a PEEP of 5cm H2O till the achievement of ROSC (return of spontaneous circulation)after a definitive airway has been established |
| Comparator Agent |
zero PEEP |
in patients presenting with cardiac arrest and randomised to the control group, CPR will be given with zero PEEP till the achievement of ROSC( return of spontaneous circulation) after a definitive airway has been established |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with cardiac arrest
2.Legally authorised representative willing to give valid consent |
|
| ExclusionCriteria |
| Details |
1.Legally authorised representative unwilling to give consent
2.Patients less than 18 years of age
3.Patients requiring surgical airway
4.patients with obstructive airway disease
5.patients with history of trauma
6.pregnant women
7.patients with metastatic cancer |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the rates to ROSC (return of spontaneous circulation) in patients receiving zero PEEP versus PEEP (5cm H2O) during CPR in cardiac arrest |
at achievement of ROSC or at maximum 40mins of CPR |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare the PCo2 clearance
|
At achievement of ROSC or 40minutes |
| 2.Ventilation related complication |
During the course of CPR |
| 3.24 hour survival rates |
At 24 hours ( if applicable) |
| Neurological outcomes |
At discharge |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
05/11/2024 |
| 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 Applicable |
| 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
|
This study is a randomised controlled pilot trial that aims to compare the difference in outcomes of patients with cardiac arrest receiving CPR with a PEEP of 5cm of H2O as against ZEEP ( PEEP of zero cm of H2O).Patients presenting to the emergency with cardiac arrest will be immediately shifted to the resuscitation area and CPR would be started; advanced airway would be secured.They would be randomised into control and intervention group after informed consent is obtained from the legally authorised representative and if they fulfil the inclusion criteria.CPR would be continued for a period of 40 minutes or till the achievement of ROSC; with blood samples taken at regular intervals for analysis.Primary outcome in this study is to compare the rates of ROSC between the control and intervention group. Secondary outcome aims to study the PCO2 clearance, ventilation related complications, 24 hour survival and neurological outcomes at discharge. |