Early Defibrillation by Smartphone-based Community First Responders in Out-of-hospital Cardiac Arrest: A Prospective Interventional Study (Early-Shock-OWL Trial)

Early Defibrillation by Smartphone-based Community First Responders in Out-of-hospital Cardiac Arrest: A Prospective Interventional Study (Early-Shock-OWL Trial) - Early Shock OWL

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00038326

Enrollment

256

Registered

2025-10-31

Start date

2025-12-01

Completion date

Unknown

Last updated

2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I46

Interventions

Group 1: No Intervention: Control Group - SCFR without AED In the control phase, Smartphone-based Community First Responders (SCFRs) respond to suspected out-of-hospital cardiac arrests (OHCA) withou

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - All adult patients with OHCA - Resusciation measures performed (Chest compressions and/or defibrillation) in accordance with Utstein criteria

Exclusion criteria

Exclusion criteria: Patients < 18 years of age Abscence of OHCA No resusication performed (e.g., clear signs of death, rigor mortis, livor mortis) Presence of do-not-resuscitate (DNR) order Traumatic cardiac arrest No CFR alerted

Design outcomes

Primary

Measure	Time frame
Time to alert activation to the first rhythm analysis The time interval (in minutes) from the initial alert (by EMS dispatch centre) to the first recorded rhythm analysis using an AED or defibrillator device Within 30 minutes of alert activation	—

Secondary

Measure	Time frame
1) Time from alert activation to first defibrillation: Within 30 minutes of alert activation 2) Rate of Return Of Spontaneous Circulation (ROSC): According to Utstein Protocol, definition of ROSC is the presence of palpable pulse. At the scene of emergency, the documentation is done through the EMS Informatics System. Time Frame: At scene (Baseline) 3) Neurological outcome at hospital discharge according to the Cerebral Performance Category (CPC): Neurological outcome at hospital discharge assessed using the Cerebral Performance Category (CPC) scale, where CPC 1-2 indicates good neurological recovery. Time Frame: At hospital discharge (up-to- 24 weeks) 4) Number of patient survival to hospital admission with ROSC: Number of patients with OHCA through CFR with ROSC and in the course of the hospital admission with ROSC. Time Frame: Time frame between enrolment and hospital admission with ROSC	—

Measure

Time frame

1) Time from alert activation to first defibrillation: Within 30 minutes of alert activation 2) Rate of Return Of Spontaneous Circulation (ROSC): According to Utstein Protocol, definition of ROSC is the presence of palpable pulse. At the scene of emergency, the documentation is done through the EMS Informatics System. Time Frame: At scene (Baseline) 3) Neurological outcome at hospital discharge according to the Cerebral Performance Category (CPC): Neurological outcome at hospital discharge assessed using the Cerebral Performance Category (CPC) scale, where CPC 1-2 indicates good neurological recovery. Time Frame: At hospital discharge (up-to- 24 weeks) 4) Number of patient survival to hospital admission with ROSC: Number of patients with OHCA through CFR with ROSC and in the course of the hospital admission with ROSC. Time Frame: Time frame between enrolment and hospital admission with ROSC

—

Countries

Germany

Contacts

Public ContactGerrit Jansen

Johannes Wesling Klinikum Minden

gerrit.jansen@muehlenkreiskliniken.de+49 571 79054400

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026