POCA: Perioperative Cardiac Arrest and Outcome

Sponsor
University Hospital Inselspital, Berne (Other)
Overall Status
Recruiting
CT.gov ID
NCT05316779
Collaborator
(none)
240
1
9.6
25.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    A perioperative cardiac arrest is a special form of an 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 arrests are also rare, especially for paediatric patients. Some reports suggest that incidence is negative associated with a higher development of a country. As no Swiss data is available on this topic, this retrospective audit aims to bridge the gap of knowledge 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 2014 until 31st December 2021 (8 years observational period).

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    240 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Perioperative Cardiac Arrest: an Observational Mono-centre 8-year Assessment of Outcome
    Actual Study Start Date :
    Apr 14, 2022
    Anticipated Primary Completion Date :
    Sep 1, 2022
    Anticipated Study Completion Date :
    Jan 30, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Return of spontaneous circulation (ROSC) [60 minutes]

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

    Secondary Outcome Measures

    1. Sustained ROSC [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 [24 hours]

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

    3. Survival to hospital discharge [4 weeks]

      Number of patients with a Survival to hospital discharge

    4. SF-12 after hospital discharge [1 month]

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

    5. CPC after hospital discharge [1 month]

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

    6. SF-12 3 month after cardiac arrest [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 [3 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Inclusion Criteria is a perioperative cardiac arrest between 1st January 2014 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 2014 of 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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Bern Bern Switzerland 3010

    Sponsors and Collaborators

    • University Hospital Inselspital, Berne

    Investigators

    • Study Director: Robert Greif, MD, Prof, University of Bern

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital Inselspital, Berne
    ClinicalTrials.gov Identifier:
    NCT05316779
    Other Study ID Numbers:
    • 2021-02330
    First Posted:
    Apr 7, 2022
    Last Update Posted:
    Jun 27, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital Inselspital, Berne
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 27, 2022