RescueDoppler- a Disruptive Ultrasound Solution for Improved Outcome After Cardiac Arrest.

NCT06599073 | Completed DMC

• 2 other identifiers: 582681332205
• Study Type: interventional
• Target: 285
• Locations: 2 countries
• Sites: 8

Brief Summary

RescueDoppler is an innovative, hands-free Doppler system designed for continuous monitoring of blood flow in the carotid artery, distinguishing between the presence and absence of a pulse. It is non-invasive, user-independent, and does not require specialized ultrasound expertise. The primary goal of this study is to assess the feasibility and clinical utility of RescueDoppler for monitoring carotid artery blood flow in patients experiencing sudden cardiac arrest. The multi-center study will be performed both pre-hospital and in-hospital.

Conditions

Cardiopulmonary Resuscitation; Doppler Ultrasound; Cardiac Arrest (CA)

Keywords

Continuous ultrasound during cardiac arrest

Outcome Measures

Primary Outcomes (1)

• Number of patients with carotid peak blood flow velocity of more than 20 cm/second during cardiopulmonary resuscitation

  A carotid peak blood flow velocity of zero indicates the absence of spontaneous circulation during cardiopulmonary resuscitation, while velocities exceeding 20 cm/second suggest the presence of spontaneous circulation.

  From enrollment to the end after 12 months

Secondary Outcomes (1)

• Number of patients with carotid peak blood flow velocity of more than 50 cm/second during chest compressions

  From enrollment to the end after 12 months

Study Arms (1)

RescueDoppler patch with probe is attached to patients with cardiac arrest

EXPERIMENTAL

The RescueDoppler probe and patch are placed on the left side of the patient's neck in both pre-hospital and in-hospital settings. The RescueDoppler system is blinded to the medical personnel during the cardiac arrest and is not used for real-time monitoring. After the cardiac arrest, the velocity curves are processed by the research team and synchronized with the ECG for analysis.

Device: RescueDoppler; Device: Rescue

Interventions

RescueDoppler DEVICE

Continuous hands-free Doppler ultrasound of the carotid artery during cardiac arrest

Also known as: Carotid Doppler

RescueDoppler patch with probe is attached to patients with cardiac arrest

Rescue DEVICE

RescueDoppler patch with probe is attached on the left side of the neck during the cardiac arrest. Operative health personell are blinded for the velocity curves that are post-processed by the research team after the cardiac arrest and synchronised with ECG.

RescueDoppler patch with probe is attached to patients with cardiac arrest

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, aged 18 years or older. Subjects experiencing a sudden cardiac arrest, either pre-hospital or in-hospital. Sudden cardiac arrest is defined as the abrupt loss of heart function, breathing, and consciousness.

You may not qualify if:

• Subjects where resuscitation is not continued after the initial application of RescueDoppler or resuscitation efforts are halted due to a do-not-resuscitate order.
• Subjects deemed unable to comply with the study requirements as determined by the Investigator.
• Subjects with extensive trauma injuries that prevent proper attachment of the RescueDoppler patch.

Sponsors & Collaborators

• St. Olavs Hospital: collaborator
• Norwegian University of Science and Technology: lead
• Nordlandssykehuset HF: collaborator
• Ullevaal University Hospital: collaborator
• Rikshospitalet University Hospital: collaborator
• University Hospital, Akershus: collaborator
• Haukeland University Hospital: collaborator

Study Sites (8)

Akershus university hospital

Loerenskog, Akershus, 1478, Norway

Location

Haukeland University Hospital, Surgical Services Clinic, Department of Emergency Medicine

Bergen, Vestland, 5201, Norway

Location

Nordland Hospital

Bodø, Norway

Location

Oslo University Hospital Ullevål location Lørenskog

Oslo, 1474, Norway

Location

Oslo University Hospital Rikshospitalet

Oslo, Norway

Location

Oslo University Hospital Ullevaal

Oslo, Norway

Location

St Olavs University Hospital

Trondheim, 7491, Norway

Location

Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location

Related Publications (2)

• Faldaas BO, Nielsen EW, Storm BS, Lappegard KT, Nilsen BA, Kiss G, Skogvoll E, Torp H, Ingul CB. Real-time feedback on chest compression efficacy by hands-free carotid Doppler in a porcine model. Resusc Plus. 2024 Feb 20;18:100583. doi: 10.1016/j.resplu.2024.100583. eCollection 2024 Jun.

  PMID: 38404755 RESULT

• Faldaas BO, Nielsen EW, Storm BS, Lappegard KT, How OJ, Nilsen BA, Kiss G, Skogvoll E, Torp H, Ingul C. Hands-free continuous carotid Doppler ultrasound for detection of the pulse during cardiac arrest in a porcine model. Resusc Plus. 2023 Jun 20;15:100412. doi: 10.1016/j.resplu.2023.100412. eCollection 2023 Sep.

  PMID: 37448689 RESULT

Related Links

• RescueDoppler website

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: September 19, 2024
• Study Start: September 19, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF, CSR
• Time Frame: Starting 6 months after the publication of results and ending 2 years later.
• Access Criteria: A data sharing agreement must be signed and submitted to the steering committee, which includes the Principal Investigator (PI) and Site Investigators (SI) from all participating hospitals in the study.

Locations

NO (7); SE (1)