Relevance of Reversible Causes During OHCA (Rebecca Study)

Out-Of-Hospital Cardiac Arrest Clinical Trial

— REBECCA  

Official title:

Relevance of Reversible Causes During OHCA (Rebecca Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05784480
• Other study ID #: Rebecca
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: July 2023
• Source: Medical University of Vienna
• Contact: Andreas Schmid, Dr.
• Phone: 014040024680
• Email: andreas.a.schmid[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Management of the reversible causes in cardiac arrest is fundamental for successful treatment of out-of-hospital cardiac arrests. Point-of-care diagnostics as prehospital emergency ultrasound, blood gas analysis and toxicological screening support the diagnostic process of evaluating potential reversible causes. Digital tools provide support of a structured approach. This study aims to evaluate the frequency of reversible causes during OHCA as well as specific interventions due to these findings. Furthermore, CPR performance (hands-off, ROSC, 30-day mortality) and cognitive load of the prehospital emergency physician will be investigated. In total 100 patients with OHCA will be included in this study. Identification of reversible causes will be performed upon a structured protocol using an interactive checklist. Cognitive load of emergency physician as well as CPR parameter (frequency of reversible causes, hands-off, ROSC, 30-day mortality) will be analysed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with prehospital cardiac arrest, where POCUS, blood gas analysis as well as screening for intoxication can integrated in ALS rhythm without delay of life-saving treatment or transportation will be included.

Exclusion Criteria:

• Patients will be excluded under the age of 18, or if POCUS, blood gas analysis will lead to a delay of live-saving treatment or transportation. Furthermore, pregnant patients will be excluded.

Related Conditions & MeSH terms

• Cardiopulmonary Arrest
• Heart Arrest
• Out-of-Hospital Cardiac Arrest

Intervention

Diagnostic Test:
• Checklist for evaluation of reversible causes
Prehospital evaluation by checklist and diagnostic testing for reversible causes of OHCA using point-of-care blood gas analysis, saliva toxicological screen and ultrasound and post-hoc toxicological analysis of blood using mass spectrometry

Locations

Country	Name	City	State
Austria	Anesthesiology and Intensive Care Medicine Department - Medical University of Vienna	Vienna
Austria	Department of Anesthesia, General Intensive Care and Pain Management,Medical University of Vienna	Vienna

Sponsors (3)

Lead Sponsor	Collaborator
Medical University of Vienna	Ludwig Boltzmann Institute for Digital Health and Prevention, Seibersdorf Labor GmbH

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of reversible causes in OHCA and alterations of treatment	The primary outcome of this study evaluates the frequency of reversible causes during OHCA.	up to 30 days
Secondary	Frequency of ROSC	Any prehospital ROSC/sustained ROSC/in-hospital ROSC	up to 30 days
Secondary	30-day mortality	rate of mortality within 30 days in case of hospital admission	up to 30 days
Secondary	Hands-off time	Hands-off time during process of identification of reversible causes	During study completion, up to 120 min
Secondary	Cognitive load	NASA Task Load Index evaluated by the prehospital emergency physician after rescue mission	1 year (evaluation in documentation phase after CPR)