INTRODUCTION

Medical emergencies are generally encountered in an hospital setting. They are referred to as “emergency codes”, the most famous being “Code Blue” (CB) which represents cardiac arrest scenario within the hospital except the critical areas. The announcement of such codes informs the specialised team of medical professionals to provide emergency cardiac life support in the area where the patient is present without disturbing the normal functioning of the hospital¹. The term was first used in early 1990² at Bethany Medical Centre in Kansas City.

The rate of successful cardiopulmonary resuscitation (CPR) has been variable in various studies ranging from 13-59%³but the overall hospital discharge of such cases is very low⁴. The outcome of CPR depends on multiple factors but the major ones are clinical condition of the patient and the timely intervention by the code blue team⁵. This shows that the quality and co-ordinated functioning of CB team is essential for a favourable outcome of CPR. Regular audit should be carried out in an institute to analyse the protocols of CB team and also look at various problems encountered during a CPR. 

At present there is no multicentre data from India capturing the various aspects of In-Hospital Cardiac Arrest (IHCA). We want to look at the data from various Intensive Care Units (ICUs) across the country so that the Indian scenario can be presented.

OBJECTIVE

Primary objective

1.     To determine the practice pattern of CPR for in-hospital cardiac arrests

Secondary objective

1.     To assess the various interventions done during CPR

METHODS:

Study design:

·      Prospective Observational Multi-Centre National Cohort Study

Patient enrolment:

The study would invite all ICUs across the country to participate in the study. The invites will be sent at frequent intervals by ISCCM office through emails. The details of the study including all the documents will be uploaded in the Research section on the ISCCM website. Each registering ICU will have one PI and one Co-PI for the study who will be responsible for ethical committee clearance (if required), data collection and study co-ordination in their ICU. The study will be initiated from 1^st April 2024 and will enroll 500 patients within 3 months, not more than 10 patients per ICU. The study would stop enrollment by 30^th June 2024. Each centre will enter the data via eCRF. 

Inclusion criteria

1.     Age > 18 years

2.     Patient having unanticipated cardiac arrest

3.     Patient’s next of kin / surrogate consent for data collection

Exclusion criteria

1.     Age < 18 years

2.     Critically ill patients with APACHE II > 25

3.     Patient who already had CPR before admission to hospital / ICU

4.     Patient brought to hospital in pulseless state

5.     Patient having do-not-resuscitate orders

Data Collection:

There wont be any change in protocol for managing a cardiac arrest situation in a hospital. The data will be collected from the Code blue sheet of a hospital and filled in the electronic case record form (eCRF). The data collection will be based on Utstein-style reporting template⁶.

The following data will be collected :

I: Patient & Institute domain

1.     Age:

2.     Sex:

3.     Pre-event cerebral performance category (CPC)

4.     Pre-existing medical conditions

-       Heart failure Y/N

-       Coronary Artery Disease Y/N

-       Diabetes Mellitus  Y/N

-       Acute kidney injury / Chronic Kidney Disease Y/N

-       Hepatic dysfunction Y/N

-       Respiratory insufficiency Y/N

5.     Code Blue team present – Y / N

6.     Type of Hospital

-       Public Teaching hospital

-       Public non-teaching hospital

-       Private teaching hospital

-       Private non-teaching hospital

II: Pre-event domain

1.     Admitting diagnosis

2.     Patient on Non-invasive ventilation / High Flow Nasal Cannula: Y/N

3.     Patient on low dose vasopressors (Norepinephrine < 0.05 ug/kg/min): Y/N

III: Cardiac Arrest domain

1.     Initial rhythm

-       Ventricular Fibrillation (VF)

-       Pulseless Ventricular tachycardia (VT)

-       Pulseless electrical activity (PEA)

-       Asystole

2.     Defibrillatory shocks delivered - Y/N

-       Time of 1^st shock

-       Time of 2^nd shock

3.     Drugs administered during CPR

-       Adrenaline

-       Amiodarone

-       Lidocaine

-       Sodabicarbonate

-       Steroids

-       Any other drug/s

4.     Advanced airway performed - Y/N/ already present

5.     Location of event

-       ICU

-       Outside ICU

IV: Post resuscitation domain

1.     Hypothermia applied – Y/ N/ NA

2.     Urgent Coronary angiography - Y/ N/ NA

V: Outcome domain

1.     Total duration of CPR

2.     Reason for CPR termination

-       Return of spontaneous circulation (ROSC) attained

-       ROSC not attained

3.     ROSC Sustained – Y/N

4.     Neurological outcome at discharge as per CPC

5.     Status at hospital discharge

-       Alive

-       Dead

Primary outcome:

1.     To determine the outcome of in-hospital unanticipated CPR events

2.     To measure the overall hospital survival

Secondary outcome:

1.     To document the neurological outcome of survivors

2.     Factors associated with improved outcome

Sample Size:

The plan is to enroll atleast 500 patients with not more than 10 patients per ICU so that we get a good mix of various centres.

INSTITUTIONAL ETHICS COMMITTEE APPROVAL

All the local PI and Co-PI should ensure that they obtain the necessary Ethics Committee approval for the study, if deemed necessary by the institute. As this is an observational data collection with no intervention, the study can also be approved by the Head of the institute or Medical Superintendent if there is no Ethics Committee in the institute. As per the latest ICMR guidelines, this study falls in minor risk category where it is eligible for ethics exemption or an expedited review by ethics committee. 

CONSENT FOR DATA COLLECTION:

This being an observational data collection with no change in the local practice of the institute, the consent is not required from the patient or their legally accepted representative. But if still the institute demands consent, then sample consent forms in Hindi and English will be provided.

STUDY FUNDING:

This is an ISCCM funded study. The ISCCM will fund the PI of the study for the expenses incurred related to software development, secretarial assistance, data analysis and other miscellaneous expenses against actual bills. No funding will be given to other investigators from other centres for contributing the data.

DATA OWNERSHIP:

As this is an ISCCM initiated project, the entire ownership of the data will be with the ISCCM.

PUBLICATION AND AUTHORSHIP POLICY:

The main results of the study will be published in a peer-reviewed medical journal.

The Authorship policy will follow the recommendations laid down by International Committee of Medical Journal Editors (ICMJE). The authorship would be decided on the basis of the contribution in study design, protocol writing, data interpretation and cleaning, data analysis and writing the final manuscript. 

Steering Committee: Members would include 2 members from the PIs centre, ISCCM President, ISCCM Past President, President Elect, Research Committee Chairman, and PIs from top 5 centres contributing maximum data. The name of the Steering Committee members will be in the main author list.

The PI and Co PI of all the contributing centres will be included in the list of study collaborators and will be indexed in PubMed.

REFERENCES:

1.     Al-Aboud KM, Al-Aboud DM. Hospital emergency codes. An appraisal. Saudi Med J. 2010 Dec;31(12):1377. PMID: 21136006.

2.     Zafari AM, Zarter SK, Heggen V, Wilson P, Taylor RA, Reddy K, Backscheider AG, Dudley SC Jr. A program encouraging early defibrillation results in improved in-hospital resuscitation efficacy. J Am Coll Cardiol. 2004 Aug 18;44(4):846-52. doi: 10.1016/j.jacc.2004.04.054. PMID: 15312869.

3.     Brindley PG, Markland DM, Mayers I, Kutsogiannis DJ. Predictors of survival following in-hospital adult cardiopulmonary resuscitation. CMAJ. 2002 Aug 20;167(4):343-8. PMID: 12197686; PMCID: PMC117846.

4.     Abe T, Tokuda Y, Ishimatsu S; SOS-KANTO study group. Predictors for good cerebral performance among adult survivors of out-of-hospital cardiac arrest. Resuscitation. 2009 Apr;80(4):431-6. doi: 10.1016/j.resuscitation.2008.12.010. Epub 2009 Jan 29. PMID: 19185409.

5.     Cummins RO, Ornato JP, Thies WH, Pepe PE. Improving survival from sudden cardiac arrest: the "chain of survival" concept. A statement for health professionals from the Advanced Cardiac Life Support Subcommittee and the Emergency Cardiac Care Committee, American Heart Association. Circulation. 1991 May;83(5):1832-47. doi: 10.1161/01.cir.83.5.1832. PMID: 2022039.

6.     Nolan JP, Berg RA, Andersen LW, Bhanji F, Chan PS, Donnino MW, et al. Cardiac Arrest and Cardiopulmonary Resuscitation Outcome Reports: Update of the Utstein Resuscitation Registry Template for In-Hospital Cardiac Arrest: A Consensus Report From a Task Force of the International Liaison Committee on Resuscitation (American Heart Association, European Resuscitation Council, Australian and New Zealand Council on Resuscitation, Heart and Stroke Foundation of Canada, InterAmerican Heart Foundation, Resuscitation Council of Southern Africa, Resuscitation Council of Asia). Circulation. 2019 Oct 29;140(18):e746-e757. doi: 10.1161/CIR.0000000000000710. Epub 2019 Sep 16. PMID: 31522544.