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Completed

NCT Number: NCT06905613

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

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.

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Key information

Conditions

Technical Feasibility Ambulances

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ambulansstationen Uppsala Region

Uppsala, Uppsala County, 75185, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

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.

Other names: Capnograph, MARIE

Primary outcomes

  1. Adequate values of ETCO2 and respiratory rate

    Time frame: During ambulance transport from the start of the transport to the arrival at the emergency department

    Verifying that credible measurements of EtCO2 and Respiratory Rate are reported during the transport.

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Collaborators

  • Uppsala University Hospital

Registry information

Acronym: MARIE

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 1, 2025
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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