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

July 23, 2023 updated by: Christina Hafner, Medical University of Vienna
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Recruiting
        • Department of Anesthesia, General Intensive Care and Pain Management,Medical University of Vienna
        • Contact:
          • Christina Hafner
      • Vienna, Austria, 1090
        • Not yet recruiting
        • Anesthesiology and Intensive Care Medicine Department - Medical University of Vienna
        • Contact:
        • Sub-Investigator:
          • Andreas Schmid, Dr.
        • Principal Investigator:
          • Christina Hafner, DDr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:
  • Point-of-care ultrasound
  • Venipuncture for toxicological screening
  • Point-of-Care blood gas analysis
  • Point-of-Care saliva toxicological screen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of reversible causes in OHCA and alterations of treatment
Time Frame: up to 30 days
The primary outcome of this study evaluates the frequency of reversible causes during OHCA.
up to 30 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Collaborators

Seibersdorf Labor GmbH
Ludwig Boltzmann Institute for Digital Health and Prevention

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

January 6, 2023

First Submitted That Met QC Criteria

March 13, 2023

First Posted (Actual)

March 27, 2023

Study Record Updates

Last Update Posted (Actual)

July 25, 2023

Last Update Submitted That Met QC Criteria

July 23, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rebecca

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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