| CTRI Number |
CTRI/2024/08/072309 [Registered on: 12/08/2024] Trial Registered Prospectively |
| Last Modified On: |
09/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to determine factors that predict return of spontaneous circulation after cardiopulmonary resuscitation performed in hospitalised patients. |
|
Scientific Title of Study
|
Predictors of return of spontaneous circulation following in-hospital cardiopulmonary resuscitation. |
| 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 Shikha Gupta |
| Designation |
Professor Anaesthesia |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Department of Anaesthesia
Dayanand Medical College and Hospital
Civil Lines
Ludhiana
Ludhiana
PUNJAB
141001
India |
| Phone |
9814820622 |
| Fax |
|
| Email |
shikhadmc@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Simranjot Kaur |
| Designation |
PG Resident Anaesthesia |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Department of Anaesthesia
Dayanand Medical College and Hospital
Civil Lines
Ludhiana
Ludhiana
PUNJAB
141001
India |
| Phone |
7626990297 |
| Fax |
|
| Email |
drsimranj98@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Simranjot Kaur |
| Designation |
PG Resident Anaesthesia |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Department of Anaesthesia
Dayanand Medical College and Hospital
Civil Lines
Ludhiana
Ludhiana
PUNJAB
141001
India |
| Phone |
7626990297 |
| Fax |
|
| Email |
drsimranj98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dayanand Medical College and Hospital, Civil Lines, Ludhiana, Punjab, India - 141001 |
|
|
Primary Sponsor
|
| Name |
Dayanand Medical College and Hospital |
| Address |
Tagore Nagar, Civil Lines, Ludhiana, 141001
Punjab
India |
| Type of Sponsor |
Private 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 |
| Dr Shikha Gupta |
Dayanand Medical College and Hospital |
Department of Anaesthesia
Dayanand Medical College and Hospital
Tagore Nagar Civil Lines
Ludhiana 141001
Ludhiana
PUNJAB |
9814820622
shikhadmc@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Ethics Committee, Dayanand Medical College and Hospital |
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 |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Age ≥ 18 years.
2. Gender: either.
3. Patients suffering cardiac arrest as defined by the cessation of cardiac mechanical activity, confirmed by the absence of signs of circulation; a detectable central pulse, unresponsiveness and apnoea.
4. Patients who suffer cardiac arrest for the first time during their hospital stay. |
|
| ExclusionCriteria |
| Details |
1. Patients with prior out-of-hospital cardiac arrest events.
2. Do Not Attempt Resuscitation (DNAR) patients.
3. Patients admitted in Intensive Care Units (ICUs).
4. Patients on whom CPR is performed, but not performed by the hospital Code Blue team. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Predictors of ROSC following CPR in in-hospital cardiac arrest |
Successful return of spontaneous circulation indicated by either a palpable pulse and/or recordable blood pressure, sustained for at least 20 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Percentage of return of spontaneous circulation achieved.
2. Final outcome : Discharge, DAMA, Expired.
3. Neurological status at discharge. |
1. Time of arrest.
2. Time at which ROSC achieved (if applicable)
3. Time of death, or discharge from hospital |
|
|
Target Sample Size
|
Total Sample Size="263"
Sample Size from India="263"
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)
|
20/08/2024 |
| 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="3"
Days="15" |
|
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
|
In-Hospital Cardiac Arrest (IH-CA) remains a condition with considerable morbidity and mortality. Various factors and patient characteristics determine the eventual development of Return of Spontaneous Circulation (ROSC), following cardiopulmonary resuscitation, survival and neurological outcome. Th aim of the study is to determine the predictors of return of return of spontaneous circulation following in-hospital cardiopulmonary resuscitation (IH-CPR). Understanding the characteristics of patients who experience cardiac arrest while hospitalised is crucial for improving outcomes. By elucidating the association between pre-existing co-morbidities, demographic factors, hospital-related variables, and post-arrest outcomes, a more holistic understanding of in-patient cardiac arrest management can be facilitated. The study will be conducted on 263 patients above 18 years of age, of either gender who, after cardiac arrest will be attended by the hospital Code Blue team and shall receive cardiopulmonary resuscitation (CPR) as per advanced cardiac arrest management protocols. Data will be collected and categorised according to pre-, intra- and post-arrest variables and statistically analysed. |