Perioperative Cardiac Arrest and Outcome

Anesthesia Clinical Trial

— POCA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05316779
• Other study ID #: 2021-02330
• Status: Completed
• Start date: April 14, 2022
• Est. completion date: October 25, 2023

Study information

• Verified date: October 2023
• Source: Insel Gruppe AG, University Hospital Bern
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: October 25, 2023
• Est. primary completion date: September 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Anesthesia
• Heart Arrest

Locations

Country	Name	City	State
Switzerland	University Hospital Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Insel Gruppe AG, University Hospital Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Return of spontaneous circulation (ROSC)	Number of patients with a Return of spontaneous circulation (ROSC) during resuscitation	60 minutes
Secondary	Sustained ROSC	Number of patients with a Return of spontaneous circulation during resuscitation over 20 minutes	60 minutes
Secondary	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
Secondary	Survival to hospital discharge	Number of patients with a Survival to hospital discharge	4 weeks
Secondary	SF-12 after hospital discharge	Health-related quality of life according (HRQOL) the Short Form Survey (SF-12) after hospital discharge	1 month
Secondary	CPC after hospital discharge	Neurological status according Clinical Performance Category (CPC) after hospital discharge	1 month
Secondary	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
Secondary	CPC 3 month after cardiac arrest	Neurological status according Clinical Performance Category (CPC) at 3 months after the peri-operative cardiac arrest	3 months