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NCT Number: NCT05316779

Perioperative Cardiac Arrest and 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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Bern

Bern, 3010, Switzerland

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Return of spontaneous circulation (ROSC)

    Time frame: 60 minutes

    Number of patients with a Return of spontaneous circulation (ROSC) during resuscitation

Secondary outcomes

  1. Sustained ROSC

    Time frame: 60 minutes

    Number of patients with a Return of spontaneous circulation during resuscitation over 20 minutes

  2. Survival post-anaesthesia care unit or intensive care unit

    Time frame: 24 hours

    Number of patients with a Survival to post-anaesthesia care unit (PACU) or intensive care unit (ICU)

  3. Survival to hospital discharge

    Time frame: 4 weeks

    Number of patients with a Survival to hospital discharge

  4. SF-12 after hospital discharge

    Time frame: 1 month

    Health-related quality of life according (HRQOL) the Short Form Survey (SF-12) after hospital discharge

  5. CPC after hospital discharge

    Time frame: 1 month

    Neurological status according Clinical Performance Category (CPC) after hospital discharge

  6. SF-12 3 month after cardiac arrest

    Time frame: 3 months

    Health-related quality of life (HRQOL) according the Short Form Survey (SF-12) at 3 months after the peri-operative cardiac arrest

  7. CPC 3 month after cardiac arrest

    Time frame: 3 months

    Neurological status according Clinical Performance Category (CPC) at 3 months after the peri-operative cardiac arrest

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

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

Acronym: POCA

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 7, 2022
Registry last updated
Oct 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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