NCT05316779

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 7, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

April 14, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2023

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2023

Completed
Last Updated

October 27, 2023

Status Verified

October 1, 2023

Enrollment Period

1.5 years

First QC Date

March 21, 2022

Last Update Submit

October 26, 2023

Conditions

Keywords

Cardiac arrestPerioperative cardiac arrestNeurological outcomeQuality of LifeIn-hospital cardiac arrest

Outcome Measures

Primary Outcomes (1)

  • Return of spontaneous circulation (ROSC)

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

    60 minutes

Secondary Outcomes (7)

  • Sustained ROSC

    60 minutes

  • Survival post-anaesthesia care unit or intensive care unit

    24 hours

  • Survival to hospital discharge

    4 weeks

  • SF-12 after hospital discharge

    1 month

  • CPC after hospital discharge

    1 month

  • +2 more secondary outcomes

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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).

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Bern

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Robert Greif, MD, Prof

    University of Bern

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2022

First Posted

April 7, 2022

Study Start

April 14, 2022

Primary Completion

September 26, 2023

Study Completion

October 25, 2023

Last Updated

October 27, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations