SurgeryNOVOCAP-PostopNCT07178236
Evaluation of a Novel Portable Capnograph (MARIE) in Adult Postoperative Patients
A study testing MARIE in people with Surgery and Anesthesia, run by Malin Jonsson Fagerlund at 1 site in Sweden.
Trial summary
Postoperative respiratory complications are common and sometimes hard to detect early. Desaturation is a late sign of reduced minute ventilation, especially if the patient is on supplemental oxygen, and measurement of arterial or endtidal CO2 will rapidly detect a reduction in minute ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Anesthesia, Postoperative Care
- What is being tested?
- MARIE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- 22 Sep 2025to 22 Dec 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult, ≥18 years of age
- Elective surgery under general anesthesia
- Planned for over night postoperative care
Who cannot join
- Tracheostomy
- Nasal obstruction
- Rhino- or oral surgery
- Not able to understand study information or signing consent form
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Novel Portable Mainstream Capnograph MARIE in Adult Postoperative Patients - A Prospective Feasibility Study
Postoperative respiratory complications are common and sometimes hard to detect early. Desaturation is a late sign of reduced minute ventilation, especially if the patient is on supplemental oxygen, and measurement of arterial or endtidal CO2 will rapidly detect a reduction in minute ventilation. Capnography offers a non-invasive and continuous measure of end-tidal expiratory pressure of carbon dioxide (EtCO2). Capnography is not a standard in postoperative care but rather quite rare. In the present study we evaluate a novel portable capnography device, MARIE, in postoperative patients.
- The primary outcome is to describe the correlation of end-tidal CO₂ (EtCO₂) measurements between MARIETM (Oxlantics Medical) and Philips Intelli Vue X3 Microstream.
- Secondary outcomes include
- Correlation between PaCO₂ and EtCO₂ measured by MARIE and Philips Intelli Vue X3 Microstream, respectively.
- Time trajectories of PaCO₂ and EtCO₂ measured using MARIE and Philips Intelli Vue X3 Microstream, respectively
- The overall agreement between the EtCO2 measured by MARIE and Philips Intelli Vue X3 Microstream and PaCO2
- Respiratory rate measured by MARIE compared to manual counting and Philips Intelli Vue X3.
- Comparison of oxygen flow by MARIE and the rotameter.
- Comfort as reported by patient.
- Usability as reported by nurse.
- Reasons for premature termination of MARIE
- Registration of technical problems, for example unexpected shut downs and blockage by mucus.
MARIE will be applied immediately after tracheal extubation after surgery. CO2 values from MARIE will be compared to EtCO2 and PaCO2 derived from capnography equipment routinely used in the hospital and blood gas analysis, at set intervals in the postoperative ward. Respiratory rate will be compared to our standard care monitors, ie Philips Intelli Vue X3, alongside manual counting. Rate of oxygen delivery, when applicable, will also be compared to the rotameter.
- Conditions
- Surgery, Anesthesia, Postoperative Care, Respiration Rate Detection, Capnography, Monitoring
- Being tested
- MARIE
- Keywords
- capnography, Postoperative, surgery, anaesthesia, monitoring, respiration, novel equipment
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MARIEDevice
Portable capnoghraphy
| Study group | Role | What they receive |
|---|---|---|
| MARIE | Experimental | Portable capnograph Receives: Device: MARIE |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is correlation of end-tidal CO₂ (EtCO₂) measurements between MARIETM (Oxlantics Medical) and Philips Intelli Vue X3 Microstream
End-tidal CO₂ (EtCO₂) measurements will be measured by MARIE (Oxlantic Medical AB) and Philips Intelli Vue X3 Microstream at several occasions and thereafter correlated
Measured: From enrolment to discharge from the postoperative unit or maximum 24 hours
Secondary outcomes (8)
Correlation between PaCO₂ and EtCO₂ measured by MARIE and Philips Intelli Vue X3 Microstream, respectively.
Measurement of arterial PCO₂ and EtCO₂ measured by MARIE and Philips Intelli Vue X3 Microstream at the same time will be done repeatedly and thereafter correlated
Measured: From enrolment in the study until discharge from the postoperative unit or maximum 24 hours
Time trajectories of PaCO₂ and EtCO₂ measured using MARIE and Philips Intelli Vue X3 Microstream, respectively
Arterial PCO₂ and EtCO₂ measured using MARIE and Philips Intelli Vue X3 Microstream will be measured repeatedly and thereafter correlated
Measured: From enrolment until discharge from the postoperative unit or maximum of 24 hours
The overall agreement between the EtCO2 measured by MARIE and Philips Intelli Vue X3 Microstream and PaCO2
EtCO2 measured by MARIE and Philips Intelli Vue X3 Microstream and PaCO2 will be collected simultaneously and repeatedly and thereafter investigated
Measured: From enrolment until discharge from the postoperative unit or a maximum of 24 hours
Respiratory rate measured by MARIE compared to manual counting and Philips Intelli Vue X3
Respiratory rate measured by MARIE compared to manual counting and Philips Intelli Vue X3 will be measured simultaneously and thereafter compared and correlated
Measured: From the enrolment in the study and until discharge from the postoperative unit or a maximum of 24 hours
Comparison of oxygen flow by MARIE and the rotameter
Oxygen flow rate by MARIE and the rotameter will be documented repeatedly and simultaneously and thereafter compared and correlated
Measured: From enrolment in the study until discharge from the postoperative unit or a maximum of 24 hours
Comfort as reported by patient as VAS (0-10).
Comfort by the patient will be scored by the patient three times/24 hours on average Visual Analogue Scale from 1-10. 0= Worst comfort, 10= Comfortable
Measured: Three times/24 hours from admission to the postoperative unit until discharge from the postoperative unit or maximum 24 hours
Usability as reported by nurse as VAS (0-10).
The nurse will score the usability on a Visual Analogue Scale (VAS) from 0-10. 0=Very low usability, 10=very high usability
Measured: From the time of enrolment until discharge from the postoperative unit of maximum 24 hours
Reasons for premature termination of MARIE
Report of reasons for premature termination
Measured: From the enrolment to the discharge from the postoperative unit or a maximum of 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start22 Sep 2025
- Primary completion15 Oct 2025
- Study completion22 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Malin Jonsson Fagerlund
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Malin Jonsson Fagerlund, Karolinska University Hospital
- Investigators
- Malin Jonsson Fagerlund, Professor, Principal investigator, Karolinska University Hospital & Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07178236
- Sponsor's protocol ID
- NOVOCAP-Postop
- Other IDs
- CIV-ID 25-06-053097
- Acronym
- NOVOCAP-Postop
- Status last verified
- Jan 2026
- First submitted
- 6 Sep 2025
- Last updated
- 21 Jan 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 21 Jan 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 Postoperative Patients - A Prospective Feasibility Study
- ClinicalTrials.gov ID
- NCT07178236
- Acronym / sponsor ID
- NOVOCAP-Postop / NOVOCAP-Postop
- Conditions
- Surgery, Anesthesia, Postoperative Care, Respiration Rate Detection, Capnography, Monitoring
- Keywords
- capnography, Postoperative, surgery, anaesthesia, monitoring, respiration, novel equipment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Malin Jonsson FagerlundUniversity, hospital or other
- Study start
- 22 Sep 2025 (actual)
- Primary completion
- 15 Oct 2025 (actual)
- Study completion
- 22 Dec 2025 (actual)
- First posted
- 17 Sep 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.
Postoperative respiratory complications are common and sometimes hard to detect early. Desaturation is a late sign of reduced minute ventilation, especially if the patient is on supplemental oxygen, and measurement of arterial or endtidal CO2 will rapidly detect a reduction in minute ventilation. Capnography offers a non-invasive and continuous measure of end-tidal expiratory pressure of carbon dioxide (EtCO2). Capnography is not a standard in postoperative care but rather quite rare. In the present study we evaluate a novel portable capnography device, MARIE, in postoperative patients.
- The primary outcome is to describe the correlation of end-tidal CO₂ (EtCO₂) measurements between MARIETM (Oxlantics Medical) and Philips Intelli Vue X3 Microstream.
- Secondary outcomes include
- Correlation between PaCO₂ and EtCO₂ measured by MARIE and Philips Intelli Vue X3 Microstream, respectively.
- Time trajectories of PaCO₂ and EtCO₂ measured using MARIE and Philips Intelli Vue X3 Microstream, respectively
- The overall agreement between the EtCO2 measured by MARIE and Philips Intelli Vue X3 Microstream and PaCO2
- Respiratory rate measured by MARIE compared to manual counting and Philips Intelli Vue X3.
- Comparison of oxygen flow by MARIE and the rotameter.
- Comfort as reported by patient.
- Usability as reported by nurse.
- Reasons for premature termination of MARIE
- Registration of technical problems, for example unexpected shut downs and blockage by mucus.
MARIE will be applied immediately after tracheal extubation after surgery. CO2 values from MARIE will be compared to EtCO2 and PaCO2 derived from capnography equipment routinely used in the hospital and blood gas analysis, at set intervals in the postoperative ward. Respiratory rate will be compared to our standard care monitors, ie Philips Intelli Vue X3, alongside manual counting. Rate of oxygen delivery, when applicable, will also be compared to the rotameter.
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: MARIEPortable capnograph |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult, ≥18 years of age
- Elective surgery under general anesthesia
- Planned for over night postoperative care
Key exclusion criteria (4 listed)
- Tracheostomy
- Nasal obstruction
- Rhino- or oral surgery
- Not able to understand study information or signing 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 capnoghraphy | Device | MARIE |
Primary outcome
The primary endpoint is correlation of end-tidal CO₂ (EtCO₂) measurements between MARIETM (Oxlantics Medical) and Philips Intelli Vue X3 Microstream
Time frame: From enrolment to discharge from the postoperative unit or maximum 24 hours
End-tidal CO₂ (EtCO₂) measurements will be measured by MARIE (Oxlantic Medical AB) and Philips Intelli Vue X3 Microstream at several occasions and thereafter correlated
8 secondary outcomes
Correlation between PaCO₂ and EtCO₂ measured by MARIE and Philips Intelli Vue X3 Microstream, respectively.
Time frame: From enrolment in the study until discharge from the postoperative unit or maximum 24 hours
Time trajectories of PaCO₂ and EtCO₂ measured using MARIE and Philips Intelli Vue X3 Microstream, respectively
Time frame: From enrolment until discharge from the postoperative unit or maximum of 24 hours
The overall agreement between the EtCO2 measured by MARIE and Philips Intelli Vue X3 Microstream and PaCO2
Time frame: From enrolment until discharge from the postoperative unit or a maximum of 24 hours
Respiratory rate measured by MARIE compared to manual counting and Philips Intelli Vue X3
Time frame: From the enrolment in the study and until discharge from the postoperative unit or a maximum of 24 hours
Comparison of oxygen flow by MARIE and the rotameter
Time frame: From enrolment in the study until discharge from the postoperative unit or a maximum of 24 hours
Comfort as reported by patient as VAS (0-10).
Time frame: Three times/24 hours from admission to the postoperative unit until discharge from the postoperative unit or maximum 24 hours
Usability as reported by nurse as VAS (0-10).
Time frame: From the time of enrolment until discharge from the postoperative unit of maximum 24 hours
Reasons for premature termination of MARIE
Time frame: From the enrolment to the discharge from the postoperative unit or a maximum of 24 hours
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 21 Jan 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. This study is not recruiting at the moment.
Malin Jonsson Fagerlund, Professor principal investigator
Karolinska University Hospital & Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MARIE in people with Surgery and Anesthesia, run by Malin Jonsson Fagerlund 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 3 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 21 Jan 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?
The primary endpoint is correlation of end-tidal CO₂ (EtCO₂) measurements between MARIETM (Oxlantics Medical) and Philips Intelli Vue X3 Microstream (time frame: From enrolment to discharge from the postoperative unit or maximum 24 hours). 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 21 Jan 2026.