Type of Access to the Blood Circulation During Cardiac Arrest Outside the Hospital
Phase 1
Recruiting
- Conditions
- Out-of-hospital cardiac arrest (OHCA)MedDRA version: 20.0Level: LLTClassification code: 10007517Term: Cardiac arrest transient Class: 10007541Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- CTIS2022-500744-38-00
- Lead Sponsor
- Præhospitalet
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 1470
Inclusion Criteria
Out-of-hospital cardiac arrest, Age = 18 years, Indication for intravenous or intraosseous vascular access during cardiac arrest
Exclusion Criteria
Blunt trauma, penetrating trauma, or burn injuries as suspected cause of the cardiac arrest, Prior enrollment in the trial, Intravenous or intraosseous vascular access already in place and working at the time of randomization
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine whether there is a difference in return of spontaneous circulation depending on the type of vascular access (intravenous or intraosseous) placed during out-of-hospital cardiac arrest;Secondary Objective: To determine whether there is a difference in survival at 30 days and/or survival at 30 days with a favorable neurological outcome (modified Rankin Scale, mRS 0-3) depending on the type of vascular access (intravenous or intraosseous) placed during out-of-hospital cardiac arrest;Primary end point(s): Sustained return of spontaneous circulation (ROSC). ROSC is defined as palpable pulses or other signs of circulation without a need for chest compressions. Sustained ROSC means that the patient withholds ROSC >20 min
- Secondary Outcome Measures
Name Time Method Secondary end point(s):Key secondary outcomes will include survival as well as neurological outcome at 30 days. Neurological outcome will be assessed with the modified Rankin Scale (mRS); scores 0-6 will be presented as counts and percentages, while the outcome will be dichotomized as favorable (mRS 0-3) vs. unfavorable (mRS 4-6).