IntubationNOVOCAP-IntubNCT07816926
Evaluation of a Novel Portable Mainstream Capnograph MARIE in Adult Intubated Patients. A Prospective Validation Study
A study testing MARIE in people with Intubation and Capnography, run by Malin Jonsson Fagerlund.
Trial summary
Primary endpoint: To describe the Bland-Altman agreement of end-tidal CO₂ (EtCO₂) measurements between MARIETM airway adapter (Oxlantic Medical AB) and a standard capnography, Getinge Flow-i, in intubated patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation, Capnography, Monitoring
- What is being tested?
- MARIE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 7 Sep 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult, ≥18 years of age
- Elective surgery under general anesthesia
- Endotracheal intubation
- Planned for arterial line
Who cannot join
- Unable to understand study information or sign the consent form
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Primary endpoint: To describe the Bland-Altman agreement of end-tidal CO₂ (EtCO₂) measurements between MARIETM airway adapter (Oxlantic Medical AB) and a standard capnography, Getinge Flow-i, in intubated patients.
- Conditions
- Intubation, Capnography, Monitoring
- Being tested
- MARIE
- Keywords
- capnography, monitoring, mainstream, novel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MARIEDevice
Portable mainstream capnography
| Study group | Role | What they receive |
|---|---|---|
| MARIE | Experimental | NOvel mainstream capnography Receives: Device: MARIE |
What is being measured
The primary outcome is the main question the study is designed to answer.
To describe the Bland-Altman agreement of end-tidal CO₂ measurements between MARIE airway adapter (Oxlantic Medical AB) and a standard capnography, Getinge Flow-i, in intubated patients.
End-tidal carbon dioxide (EtCO2) will be measured by a standard capnograph from the company Getinge Flow-i and be compared to the end-tidal carbon dioxide of a novel portable mainstream capnograph MARIE
Measured: During anesthesia and mechanical ventilation
Secondary outcomes (8)
Correlation of end-tidal CO₂ (EtCO₂) measurements between MARIE and Getinge Flow-i
Measured: During anesthesia and mechanical ventilation maximum up to 12 hours after start of anesthesia
Correlation between PaCO₂ and EtCO₂ measured by MARIE and Getinge Flow-i, respectively.
Measured: During anesthesia and mechanical ventilation maximum up to 12 hours after start of anesthesia
Time trajectories of PaCO₂ and EtCO₂ measured using MARIE and Getinge Flow-i, respectively.
Measured: During anesthesia and mechanical ventilation maximum up to 12 hours after start of anesthesia
Overall agreement between EtCO₂ measured by MARIE, Getinge Flow-i, and PaCO₂.
Measured: During anesthesia and mechanical ventilation maximum up to 12 hours after start of anesthesia
Respiratory rate measured by MARIE compared to Getinge Flow-i.
Measured: During anesthesia and mechanical ventilation maximum up to 12 hours after start of anesthesia
Usability as reported by nurse.
Measured: During anesthesia and mechanical ventilation maximum up to 12 hours after start of anesthesia
Reasons for premature termination of MARIE.
Measured: During anesthesia and mechanical ventilation maximum up to 12 hours after start of anesthesia
Registration of technical problems, e.g. unexpected shutdowns or blockage by mucus.
Measured: During anesthesia and mechanical ventilation maximum up to 12 hours after start of anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start7 Sep 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IntubationStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Malin Jonsson Fagerlund
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Malin Jonsson Fagerlund, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07816926
- Sponsor's protocol ID
- NOVOCAP-Intub
- Other IDs
- CIV-26-07-059154
- Acronym
- NOVOCAP-Intub
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Novel Portable Mainstream Capnograph MARIE in Adult Intubated Patients. A Prospective Validation Study
- ClinicalTrials.gov ID
- NCT07816926
- Acronym / sponsor ID
- NOVOCAP-Intub / NOVOCAP-Intub
- Conditions
- Intubation, Capnography, Monitoring
- Keywords
- capnography, monitoring, mainstream, novel
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Malin Jonsson FagerlundUniversity, hospital or other
- Study start
- 7 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Sep 2026 (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.
Primary endpoint: To describe the Bland-Altman agreement of end-tidal CO₂ (EtCO₂) measurements between MARIETM airway adapter (Oxlantic Medical AB) and a standard capnography, Getinge Flow-i, in intubated patients.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MARIE | Experimental | Device: MARIENOvel mainstream capnography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult, ≥18 years of age
- Elective surgery under general anesthesia
- Endotracheal intubation
- Planned for arterial line
Key exclusion criteria (1 listed)
- Unable to understand study information or sign the consent form
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 |
|---|---|---|
| MARIEPortable mainstream capnography | Device | MARIE |
Primary outcome
To describe the Bland-Altman agreement of end-tidal CO₂ measurements between MARIE airway adapter (Oxlantic Medical AB) and a standard capnography, Getinge Flow-i, in intubated patients.
Time frame: During anesthesia and mechanical ventilation
End-tidal carbon dioxide (EtCO2) will be measured by a standard capnograph from the company Getinge Flow-i and be compared to the end-tidal carbon dioxide of a novel portable mainstream capnograph MARIE
8 secondary outcomes
Correlation of end-tidal CO₂ (EtCO₂) measurements between MARIE and Getinge Flow-i
Time frame: During anesthesia and mechanical ventilation maximum up to 12 hours after start of anesthesia
Correlation between PaCO₂ and EtCO₂ measured by MARIE and Getinge Flow-i, respectively.
Time frame: During anesthesia and mechanical ventilation maximum up to 12 hours after start of anesthesia
Time trajectories of PaCO₂ and EtCO₂ measured using MARIE and Getinge Flow-i, respectively.
Time frame: During anesthesia and mechanical ventilation maximum up to 12 hours after start of anesthesia
Overall agreement between EtCO₂ measured by MARIE, Getinge Flow-i, and PaCO₂.
Time frame: During anesthesia and mechanical ventilation maximum up to 12 hours after start of anesthesia
Respiratory rate measured by MARIE compared to Getinge Flow-i.
Time frame: During anesthesia and mechanical ventilation maximum up to 12 hours after start of anesthesia
Usability as reported by nurse.
Time frame: During anesthesia and mechanical ventilation maximum up to 12 hours after start of anesthesia
Reasons for premature termination of MARIE.
Time frame: During anesthesia and mechanical ventilation maximum up to 12 hours after start of anesthesia
Registration of technical problems, e.g. unexpected shutdowns or blockage by mucus.
Time frame: During anesthesia and mechanical ventilation maximum up to 12 hours after start of anesthesia
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing MARIE in people with Intubation and Capnography, run by Malin Jonsson Fagerlund.
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 4 inclusion and 1 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: opening soon, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Malin Jonsson Fagerlund, Professor (+46 8 12372107, malin.jonsson-fagerlund@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To describe the Bland-Altman agreement of end-tidal CO₂ measurements between MARIE airway adapter (Oxlantic Medical AB) and a standard capnography, Getinge Flow-i, in intubated patients. (time frame: During anesthesia and mechanical ventilation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2026.