Technical FeasibilityMARIENCT06905613
Technical Feasibility Study of a Novel Wearable Capnograph (MARIE) in an Emergency Care Environment, Part 1
A study testing Technical feasibility study of a novel wearable capnograph (MARIE) in an emergency care environment in people with Technical Feasibility and Ambulances, run by Uppsala University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Technical Feasibility, Ambulances
- What is being tested?
- Technical feasibility study of a novel wearable capnograph (MARIE) in an emergency care environment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteSweden
- Study dates
- 19 Dec 2024to 28 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 20 healthy volunteers 18-84 years
- 30 patients between 18-84 years being transported by ambulance
Who cannot join
- Priority 1 ambulance transports
- Patients needing oxygen supply
- Known pregnancy
- Patients unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Technical feasibility study of a novel wearable capnograph (MARIE) in an emergency care environment
- Keywords
- MARIE Capnograph, MARIE Nasal Adapter Set O2 - Adult, Mainstream Respiratory Infrared Equipment, capnograph
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technical feasibility study of a novel wearable capnograph (MARIE) in an emergency care environmentDevice
Also called Capnograph, MARIE
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Technical feasibility study of a novel wearable capnograph (MARIE) in an emergency care environment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequate values of ETCO2 and respiratory rate
Verifying that credible measurements of EtCO2 and Respiratory Rate are reported during the transport.
Measured: During ambulance transport from the start of the transport to the arrival at the emergency department
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start19 Dec 2024
- Primary completion31 Jan 2025
- Study completion28 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Technical FeasibilityStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- In the first step we will include 20 Healthy volunters and if no AE we plan to include 30 patients
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University Hospital
- Responsible party
- Sponsor
- Investigators
- David Smekal, MD, PhD, docent, Principal investigator, Department of Surgical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06905613
- Sponsor's protocol ID
- 5.1-2024-76464
- Acronym
- MARIE
- Status last verified
- Apr 2026
- First submitted
- 16 Dec 2024
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pedrotti N, Larsson A, Fagerlund MJ, Smekal D. An exploratory feasibility study of a novel portable mainstream capnograph in a prehospital environment. Int J Emerg Med. 2026 Jul 21;19(1):186. doi: 10.1186/s12245-026-01312-z.
PubMed 42481937
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technical Feasibility Study of a Novel Wearable Capnograph (MARIE) in an Emergency Care Environment, Part 1
- ClinicalTrials.gov ID
- NCT06905613
- Acronym / sponsor ID
- MARIE / 5.1-2024-76464
- Conditions
- Technical Feasibility, Ambulances
- Keywords
- MARIE Capnograph, MARIE Nasal Adapter Set O2 - Adult, Mainstream Respiratory Infrared Equipment, capnograph
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Uppsala University Hospital
- Study start
- 19 Dec 2024 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 28 Mar 2025 (actual)
- First posted
- 1 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- In the first step we will include 20 Healthy volunters and if no AE we plan to include 30 patients
| Arm | Type | Receives |
|---|---|---|
| Technical feasibility study of a novel wearable capnograph (MARIE) in an emergency care environmen | Other | Device: Technical feasibility study of a novel wearable capnograph (MARIE) in an emergency care environmentMARIE 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 20 healthy volunteers 18-84 years
- 30 patients between 18-84 years being transported by ambulance
Key exclusion criteria (4 listed)
- Priority 1 ambulance transports
- Patients needing oxygen supply
- Known pregnancy
- Patients unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Technical feasibility study of a novel wearable capnograph (MARIE) in an emergency care environmentAlso: Capnograph, MARIEMARIE 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 environmen |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Derived from this study: PubMed 42481937Pedrotti N, Larsson A, Fagerlund MJ, Smekal D. An exploratory feasibility study of a novel portable mainstream capnograph in a prehospital environment. Int J Emerg Med. 2026 Jul 21;19(1):186. doi: 10.1186/s12245-026-01312-z.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Smekal, MD, PhD, docent principal investigator
Department of Surgical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technical feasibility study of a novel wearable capnograph (MARIE) in an emergency care environment in people with Technical Feasibility and Ambulances, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06905613, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.