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Clinical trial

The clinical trial is divided in a pilot study and a multicenter trial

Pilot study

The pilot study began on September 29, 2023, at Nordland Hospital in Bodø and was soon followed by St. Olavs Hospital in Trondheim on October 2. It concluded on September 16, 2024.

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This early feasibility study aimed to assess the RescueDoppler system in patients experiencing cardiac arrest in both pre-hospital and in-hospital settings. The primary objectives were to evaluate signal quality, the fastening device, overall functionality, data signal management, and the clinical utility of blood flow information. Additionally, the study assessed the initial safety of the system in accordance with its intended use.

Multi center study

The multicenter study began on September 17, 2024, when OUS Ullevål started enrolling patients with in-hospital cardiac arrest, alongside the hospitals involved in the pilot study. Akershus University Hospital and OUS Rikshospitalet joined the study in January 2025.

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This feasibility study aims to include 300 patients experiencing pre-hospital and in-hospital cardiac arrest, with an estimated recruitment period of one year. Beyond assessing feasibility, the study seeks to gather critical medical and physiological data on circulation.

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Inclusion criteria:

For inclusion in the study, subjects must fulfil all following criteria:

  1. Male or female, aged 18 years or older

  2. Subjects who present pre-hospital or in-hospital with a sudden cardiac arrest. Sudden cardiac arrest is defined as the abrupt loss of heart function, breathing and consciousness

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Exclusion criteria:

A subject who fulfils any of the following criteria must not be

included in the study:

  1. Resuscitation efforts are halted due to a do-not resuscitate order

  2. Extensive trauma injuries that prevent attachment of the RescueDoppler patch

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