REBECCA: Relevance of Reversible Causes During OHCA (Rebecca Study)

Sponsor

Medical University of Vienna (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05784480

Collaborator

Seibersdorf Labor GmbH (Industry), Ludwig Boltzmann Institute for Digital Health and Prevention (Other)

100

Enrollment

Locations

Arm

Anticipated Duration (Months)

Patients Per Site

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Out-Of-Hospital Cardiac Arrest Cardiopulmonary Arrest	Diagnostic Test: Checklist for evaluation of reversible causes	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Relevance of Reversible Causes During OHCA (Rebecca Study)

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Other: Evaluation of reversible causes using digital checklist and diagnostic support	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 Other Names: Venipuncture for toxicological screening Point-of-Care blood gas analysis Point-of-Care saliva toxicological screen Point-of-care ultrasound

Arm

Intervention/Treatment

Other: Evaluation of reversible causes using digital checklist and diagnostic support

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

Other Names:

Venipuncture for toxicological screening

Point-of-Care blood gas analysis

Point-of-Care saliva toxicological screen

Point-of-care ultrasound

Outcome Measures

Primary Outcome Measures

Frequency of reversible causes in OHCA and alterations of treatment [up to 30 days]
The primary outcome of this study evaluates the frequency of reversible causes during OHCA.

Secondary Outcome Measures

Frequency of ROSC [up to 30 days]
Any prehospital ROSC/sustained ROSC/in-hospital ROSC
30-day mortality [up to 30 days]
rate of mortality within 30 days in case of hospital admission
Hands-off time [During study completion, up to 120 min]
Hands-off time during process of identification of reversible causes
Cognitive load [1 year (evaluation in documentation phase after CPR)]
NASA Task Load Index evaluated by the prehospital emergency physician after rescue mission

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Anesthesiology and Intensive Care Medicine Department - Medical University of Vienna	Vienna		Austria	1090
2	Department of Anesthesia, General Intensive Care and Pain Management,Medical University of Vienna	Vienna		Austria	1090