Technical Feasibility Study of a Novel Wearable Capnograph (MARIE) in an Emergency Care Environment, Part 1

Uppsala University

Status: Enrolling

Conditions: Technical Feasibility; Ambulances

Treatments: Device: Technical feasibility study of a novel wearable capnograph (MARIE) in an emergency care environment

Study type: Interventional

Funder types: Other

Identifiers

NCT06905613

5.1-2024-76464

Details and patient eligibility

About

You have been assessed by paramedics as needing to go to the emergency department. During transport, the paramedics will monitor you by, for example, measuring your blood pressure and checking your pulse.

In healthcare, we are constantly working to improve and optimize the degree of monitoring during ambulance transports and through this also be able to start adequate treatment earlier. In this case, we are working to understand whether exhaled carbon dioxide levels can be used to monitor important processes in the body during ambulance transport. Therefore, we offer you to participate in a project that deals with whether we can use a new equipment to measure and monitor exhaled carbon dioxide during the journey to hospital.

This clinical trial is being conducted in Region Uppsala in collaboration with Oxlantic Medical AB. The main responsible and Sponsor for the trial is Oxlantic Medical AB. The research lead for the trial is Region Uppsala and Uppsala University.

This clinical trial has been subject to ethical review and approved by the Ethics Review Authority.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 20 healthy volunteers 18-84 years
• 30 patients between 18-84 years being transported by ambulance

Exclusion criteria

• Priority 1 ambulance transports
• Patients needing oxygen supply
• Known pregnancy
• Patients unable to provide informed consent

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Technical feasibility study of a novel wearable capnograph (MARIE) in an emergency care environmen

Other group

Description:

MARIE will be connected to the patient by attaching the nasal adapter set and connecting the CO2 sensor. ETCO2 and RR values will be logged before and during the transport by writing down the values in the Case Report Form (CRF). On arrival at the hospital ETCO2 and RR will be measured by a reference instrument and logged in to the CRF. There will be trained study personnel responsible for operating the investigational device and populating the CRF, capturing all information which is required according to the study protocol.

Treatment:

Device: Technical feasibility study of a novel wearable capnograph (MARIE) in an emergency care environment