Heart ArrestPOCANCT05316779
Perioperative Cardiac Arrest and Outcome
An observational study of Heart Arrest and Anesthesia, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Arrest, Anesthesia
- How many people
- 240 participants
- Where
- 1 siteSwitzerland
- Study dates
- 14 Apr 2022to 25 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
None listed.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Heart Arrest, Anesthesia
- Keywords
- Cardiac arrest, Perioperative cardiac arrest, Neurological outcome, Quality of Life, In-hospital cardiac arrest
- Medical subject headings
- Heart Arrest
What is being measured
The primary outcome is the main question the study is designed to answer.
Return of spontaneous circulation (ROSC)
Number of patients with a Return of spontaneous circulation (ROSC) during resuscitation
Measured: 60 minutes
Secondary outcomes (7)
Sustained ROSC
Number of patients with a Return of spontaneous circulation during resuscitation over 20 minutes
Measured: 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)
Measured: 24 hours
Survival to hospital discharge
Number of patients with a Survival to hospital discharge
Measured: 4 weeks
SF-12 after hospital discharge
Health-related quality of life according (HRQOL) the Short Form Survey (SF-12) after hospital discharge
Measured: 1 month
CPC after hospital discharge
Neurological status according Clinical Performance Category (CPC) after hospital discharge
Measured: 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
Measured: 3 months
CPC 3 month after cardiac arrest
Neurological status according Clinical Performance Category (CPC) at 3 months after the peri-operative cardiac arrest
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start14 Apr 2022
- Primary completion26 Sep 2023
- Study completion25 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart ArrestStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Greif, MD, Prof, Study director, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05316779
- Sponsor's protocol ID
- 2021-02330
- Acronym
- POCA
- Status last verified
- Oct 2023
- First submitted
- 21 Mar 2022
- Last updated
- 27 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Cardiac Arrest: an Observational Mono-centre 8-year Assessment of Outcome
- ClinicalTrials.gov ID
- NCT05316779
- Acronym / sponsor ID
- POCA / 2021-02330
- Conditions
- Heart Arrest, Anesthesia
- Keywords
- Cardiac arrest, Perioperative cardiac arrest, Neurological outcome, Quality of Life, In-hospital cardiac arrest
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 14 Apr 2022 (actual)
- Primary completion
- 26 Sep 2023 (actual)
- Study completion
- 25 Oct 2023 (actual)
- First posted
- 7 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Return of spontaneous circulation (ROSC)
Time frame: 60 minutes
Number of patients with a Return of spontaneous circulation (ROSC) during resuscitation
7 secondary outcomes
Sustained ROSC
Time frame: 60 minutes
Survival post-anaesthesia care unit or intensive care unit
Time frame: 24 hours
Survival to hospital discharge
Time frame: 4 weeks
SF-12 after hospital discharge
Time frame: 1 month
CPC after hospital discharge
Time frame: 1 month
SF-12 3 month after cardiac arrest
Time frame: 3 months
CPC 3 month after cardiac arrest
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Greif, MD, Prof study director
University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Arrest and Anesthesia, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Return of spontaneous circulation (ROSC) (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2023.