Clinical trial
The clinical trial is divided in a pilot study and a multicenter trial
Pilot study
The pilot study commenced September 29th, 2023, at Nordland hospital in Bodø, quickly followed by St. Olavs hospital in Trondheim the 2nd of October. The pilot study ended September 16th, 2024.
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It was an early feasibility study designed to assess the RescueDoppler system when used on patients with cardiac arrests in a pre-hospital and in-hospital setting. The goal was to collect data about signal quality, fastening device, functionality, data signal management and usefulness of the blood flow information as well as to evaluate the initial clinical safety as per intended use.
Multi center study
The multicenter study started September 17th, 2024, when OUS Ullevål began to enrol patients presenting with in-hospital cardiac arrest. Akershus university hospital plans to join the RescueDoppler study in November followed by OUS Rikshospitalet in January, 2025.
This traditional feasibility study will include 300 patients with pre-hospital and in-hospital cardiac arrests with a recruitment periode estimated til be one year. The aim is to obtain key medical and physiological information about the circulation beyond pure feasibility. ​​
Inclusion criteria:
For inclusion in the study, subjects must fulfil all following criteria:
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Male or female, aged 18 years or older
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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:
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Resuscitation efforts are halted due to a do-not resuscitate order
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Extensive trauma injuries that prevent attachment of the RescueDoppler patch