Back to resultsRelevance of Reversible Causes During OHCA (Rebecca Study) (REBECCA)
Primary Purpose
Out-Of-Hospital Cardiac Arrest, Cardiopulmonary Arrest
Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Checklist for evaluation of reversible causes
Sponsored by
About this trial
This is an interventional diagnostic trial for Out-Of-Hospital Cardiac Arrest focused on measuring Intoxication, Prehospital POCUS, CPR, Sonography, Blood gas analysis, Cardiac arrest, OHCA, Reversible causes, Tele-support, Checklist, Prehospital emergency physician, Emergency medicine
Eligibility Criteria
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.
Sites / Locations
- Anesthesiology and Intensive Care Medicine Department - Medical University of Vienna
- Department of Anesthesia, General Intensive Care and Pain Management,Medical University of ViennaRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Evaluation of reversible causes using digital checklist and diagnostic support
Arm Description
Outcomes
Primary Outcome Measures
Frequency of reversible causes in OHCA and alterations of treatment
The primary outcome of this study evaluates the frequency of reversible causes during OHCA.
Secondary Outcome Measures
Frequency of ROSC
Any prehospital ROSC/sustained ROSC/in-hospital ROSC
30-day mortality
rate of mortality within 30 days in case of hospital admission
Hands-off time
Hands-off time during process of identification of reversible causes
Cognitive load
NASA Task Load Index evaluated by the prehospital emergency physician after rescue mission
Full Information
NCT ID
NCT05784480
First Posted
January 6, 2023
Last Updated
July 23, 2023
Sponsor
Medical University of Vienna
Collaborators
Seibersdorf Labor GmbH, Ludwig Boltzmann Institute for Digital Health and Prevention
1. Study Identification
Unique Protocol Identification Number
NCT05784480
Brief Title
Relevance of Reversible Causes During OHCA (Rebecca Study)
Acronym
REBECCA
Official Title
Relevance of Reversible Causes During OHCA (Rebecca Study)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
Collaborators
Seibersdorf Labor GmbH, Ludwig Boltzmann Institute for Digital Health and Prevention
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Out-Of-Hospital Cardiac Arrest, Cardiopulmonary Arrest
Keywords
Intoxication, Prehospital POCUS, CPR, Sonography, Blood gas analysis, Cardiac arrest, OHCA, Reversible causes, Tele-support, Checklist, Prehospital emergency physician, Emergency medicine
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Evaluation of reversible causes using digital checklist and diagnostic support
Arm Type
Other
Intervention Type
Diagnostic Test
Intervention Name(s)
Checklist for evaluation of reversible causes
Other Intervention Name(s)
Venipuncture for toxicological screening, Point-of-Care blood gas analysis, Point-of-Care saliva toxicological screen, Point-of-care ultrasound
Intervention Description
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
Primary Outcome Measure Information:
Title
Frequency of reversible causes in OHCA and alterations of treatment
Description
The primary outcome of this study evaluates the frequency of reversible causes during OHCA.
Time Frame
up to 30 days
Secondary Outcome Measure Information:
Title
Frequency of ROSC
Description
Any prehospital ROSC/sustained ROSC/in-hospital ROSC
Time Frame
up to 30 days
Title
30-day mortality
Description
rate of mortality within 30 days in case of hospital admission
Time Frame
up to 30 days
Title
Hands-off time
Description
Hands-off time during process of identification of reversible causes
Time Frame
During study completion, up to 120 min
Title
Cognitive load
Description
NASA Task Load Index evaluated by the prehospital emergency physician after rescue mission
Time Frame
1 year (evaluation in documentation phase after CPR)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andreas Schmid, Dr.
Phone
014040024680
Email
andreas.a.schmid@meduniwien.ac.at
First Name & Middle Initial & Last Name or Official Title & Degree
Christina Hafner, DDr.
Email
christina.hafner@meduniwien.ac.at
Facility Information:
Facility Name
Anesthesiology and Intensive Care Medicine Department - Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oliver Kimberger, Prof.
Email
vorstand_anaesthesie@medunwien.ac.at
First Name & Middle Initial & Last Name & Degree
Andreas Schmid, Dr.
First Name & Middle Initial & Last Name & Degree
Christina Hafner, DDr.
Facility Name
Department of Anesthesia, General Intensive Care and Pain Management,Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Hafner
12. IPD Sharing Statement
Learn more about this trial
Relevance of Reversible Causes During OHCA (Rebecca Study)
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