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

NCT ID: NCT06905613

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-19
• Study Completion Date: 2025-03-28

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

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

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.

Group Type: OTHER

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

Intervention Type: 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.

Interventions

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

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.

Intervention Type: DEVICE

Other Intervention Names

Capnograph; MARIE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Uppsala University Hospital

OTHER

Sponsor Role: collaborator

Oxlantic Medical AB

UNKNOWN

Sponsor Role: collaborator

Uppsala University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Smekal, MD, PhD, docent

Role: PRINCIPAL_INVESTIGATOR

Department of Surgical Sciences

Locations

Ambulansstationen Uppsala Region

Uppsala, Uppsala County, Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

David Smekal, MD, PhD, docent

Role: CONTACT

david.smekal@uu.se

+46 706 117 150

Niccolo Pedrotti, MD, PhD student

Role: CONTACT

niccolo.pedrotti@surgsci.uu.se

Facility Contacts

David Smekal, Md Phd

Role: primary

david.smekal@uu.se

+46186110000

Other Identifiers

5.1-2024-76464

Identifier Type: -

Identifier Source: org_study_id