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Completed

NCT Number: NCT07178236

Evaluation of a Novel Portable Capnograph (MARIE) in Adult Postoperative Patients

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.

1. The primary outcome is to describe the correlation of end-tidal CO₂ (EtCO₂) measurements between MARIETM (Oxlantics Medical) and Philips Intelli Vue X3 Microstream. 2. Secondary outcomes include

1. Correlation between PaCO₂ and EtCO₂ measured by MARIE and Philips Intelli Vue X3 Microstream, respectively. 2. Time trajectories of PaCO₂ and EtCO₂ measured using MARIE and Philips Intelli Vue X3 Microstream, respectively 3. The overall agreement between the EtCO2 measured by MARIE and Philips Intelli Vue X3 Microstream and PaCO2 4. Respiratory rate measured by MARIE compared to manual counting and Philips Intelli Vue X3. 5. Comparison of oxygen flow by MARIE and the rotameter. 6. Comfort as reported by patient. 7. Usability as reported by nurse. 8. Reasons for premature termination of MARIE 9. 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska University Hospital

Stockholm, 17176, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult, ≥18 years of age
  • Elective surgery under general anesthesia
  • Planned for over night postoperative care

Exclusion criteria

  • Tracheostomy
  • Nasal obstruction
  • Rhino- or oral surgery
  • Not able to understand study information or signing consent form

Treatment and study plan

MARIE

Device

Portable capnoghraphy

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    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

  2. 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

    Arterial PCO₂ and EtCO₂ measured using MARIE and Philips Intelli Vue X3 Microstream will be measured repeatedly and thereafter correlated

  3. 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

    EtCO2 measured by MARIE and Philips Intelli Vue X3 Microstream and PaCO2 will be collected simultaneously and repeatedly and thereafter investigated

  4. 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

    Respiratory rate measured by MARIE compared to manual counting and Philips Intelli Vue X3 will be measured simultaneously and thereafter compared and correlated

  5. 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

    Oxygen flow rate by MARIE and the rotameter will be documented repeatedly and simultaneously and thereafter compared and correlated

  6. 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

    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

  7. 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

    The nurse will score the usability on a Visual Analogue Scale (VAS) from 0-10. 0=Very low usability, 10=very high usability

  8. Reasons for premature termination of MARIE

    Time frame: From the enrolment to the discharge from the postoperative unit or a maximum of 24 hours

    Report of reasons for premature termination

Sponsors and collaborators

Lead sponsor

Malin Jonsson Fagerlund

Other

Registry information

Official study title

Evaluation of a Novel Portable Mainstream Capnograph MARIE in Adult Postoperative Patients - A Prospective Feasibility Study

Acronym: NOVOCAP-Postop

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 17, 2025
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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