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

NCT06905613 | Completed

• 1 other identifier: 5.1-2024-76464
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Technical Feasibility; Ambulances

Keywords

MARIE Capnograph; MARIE Nasal Adapter Set O2 - Adult; Mainstream Respiratory Infrared Equipment; capnograph

Outcome Measures

Primary Outcomes (1)

• Adequate values of ETCO2 and respiratory rate

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

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

Study Arms (1)

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

OTHER

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.

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

Interventions

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.

Also known as: Capnograph, MARIE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Uppsala University: lead
• Uppsala University Hospital: collaborator

Study Sites (1)

Ambulansstationen Uppsala Region

Uppsala, Uppsala County, 75185, Sweden

Location

Study Officials

• David Smekal, MD, PhD, docent

  Department of Surgical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: In the first step we will include 20 Healthy volunters and if no AE we plan to include 30 patients

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: April 1, 2025
• Study Start: December 19, 2024
• Primary Completion: January 31, 2025
• Study Completion: March 28, 2025
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

SE (1)