Perioperative Cardiac Arrest and Outcome (POCA)

Perioperative Cardiac Arrest: an Observational Mono-centre 8-year Assessment of Outcome

With ethical approvement, the investigators want to assess the incidence, circumstances and outcomes of patients with perioperative cardiac arrests over a period of 8 years.

Currently, there is little data and information about a cardiovascular arrests during anesthesia. Little is also known about the health-related quality of life afterwards. In the investigators research project, the investigators want to find out if there are, for example, specific factors that cause cardiovascular arrests and factors that can improve the chances of survival after a cardiovascular arrest. The investigators are also looking for possible factors and measurements that can minimize or even prevent future events during anesthesia.

Study Overview

• Status: Completed
• Conditions: Heart Arrest; Anesthesia

Detailed Description

A perioperative cardiac arrest is a special form of in-hospital cardiac arrest. It was claimed that perioperative cardiac arrests are under-investigated. The spare existing data suggest incidences of perioperative cardiac arrest to be between 0.5 - 3 per 10.000 for adult patients and 2 - 10 per 10.000 for paediatric patients. Data on circumstances, predictors and outcomes of perioperative cardiac arrest are rare, especially for paediatric patients. Some reports suggest that incidence is negatively associated with a country's higher development. As no Swiss data is available on this topic, this retrospective audit aims to bridge the knowledge gap and finally intends to make clinicians aware of potential risks or contributing factors of survival, which might raise safety for all patients undergoing procedures under anaesthesia.

The investigators will include all patients of all ages with a perioperative cardiac arrest at Bern University Hospital from 1st January 2015 until 31st December 2021 (7 year observational period).

• Study Type: Observational
• Enrollment (Actual): 240

Contacts and Locations

• Study Contact: Name: Alexander Fuchs, MD; Phone Number: +41 31 66 4 14 65; Email: alexander.fuchs@insel.ch
• Study Contact Backup: Name: Thomas Riva, MD; Phone Number: +41326325201; Email: thomas.riva@insel.ch

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • University Hospital Bern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The investigators will include all patients of all ages with a perioperative cardiac arrest at Bern University Hospital from 1st January 2015 until 31st December 2021.

Description

Inclusion Criteria is a perioperative cardiac arrest between 1st January 2015 and 31st December 2021 at Bern University Hospital.

A perioperative cardiac arrest is defined as:

• ≥5 chest compressions (direct, mechanical or extracorporeal Cardiopulmonary Resuscitation (CPR))
• and/or defibrillation (unsynchronised direct current (DC) shock for ventricular fibrillation (VF) or pulseless ventricular tachycardia (pVT) either - external or internal defibrillation with manual or Automated External Defibrillation (AED), shocks by implanted cardioverter defibrillators (ICDs) for VF/pVT, precordial thump)
• In a patient having a procedure under the care of an anaesthesia team (nurse or anaesthesiologist) at the Bern University Hospital: General anaesthesia, regional anaesthesia/ analgesia, sedation, local anaesthesia or monitored anaesthesia care
• Regional block performed by anaesthesiologist outside of operating room
• Obstetric analgesia including remifentanil patient-controlled analgesia (PCA).

Exclusion Criteria:

• A perioperative cardiac arrest before 1st January 2015 or after 31st December 2021
• <5 chest compressions (direct, mechanical or extracorporeal Cardiopulmonary Resuscitation (CPR))
• All in-hospital cardiac arrests, that occur without being under anaesthesia care
• Patients already admitted to a hospital with a cardiac arrest (out-of hospital cardiac arrests)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Return of spontaneous circulation (ROSC)	Number of patients with a Return of spontaneous circulation (ROSC) during resuscitation	60 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sustained ROSC	Number of patients with a Return of spontaneous circulation during resuscitation over 20 minutes	60 minutes
Survival post-anaesthesia care unit or intensive care unit	Number of patients with a Survival to post-anaesthesia care unit (PACU) or intensive care unit (ICU)	24 hours
Survival to hospital discharge	Number of patients with a Survival to hospital discharge	4 weeks
SF-12 after hospital discharge	Health-related quality of life according (HRQOL) the Short Form Survey (SF-12) after hospital discharge	1 month
CPC after hospital discharge	Neurological status according Clinical Performance Category (CPC) after hospital discharge	1 month
SF-12 3 month after cardiac arrest	Health-related quality of life (HRQOL) according the Short Form Survey (SF-12) at 3 months after the peri-operative cardiac arrest	3 months
CPC 3 month after cardiac arrest	Neurological status according Clinical Performance Category (CPC) at 3 months after the peri-operative cardiac arrest	3 months

Collaborators and Investigators

• Sponsor: Insel Gruppe AG, University Hospital Bern
• Investigators: Study Director: Robert Greif, MD, Prof, University of Bern

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2022
• Primary Completion (Actual): September 26, 2023
• Study Completion (Actual): October 25, 2023

Study Registration Dates

• First Submitted: March 21, 2022
• First Submitted That Met QC Criteria: March 30, 2022
• First Posted (Actual): April 7, 2022

Study Record Updates

• Last Update Posted (Actual): October 27, 2023
• Last Update Submitted That Met QC Criteria: October 26, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Quality of Life; Cardiac arrest; Perioperative cardiac arrest; Neurological outcome; In-hospital cardiac arrest
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest
• Other Study ID Numbers: 2021-02330

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No