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NCT Number: NCT07816926

Evaluation of a Novel Portable Mainstream Capnograph MARIE in Adult Intubated Patients. A Prospective Validation 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.

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Key information

Conditions

Intubation Capnography Monitoring

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

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
  • Endotracheal intubation
  • Planned for arterial line

Exclusion criteria

  • Unable to understand study information or sign the consent form

Treatment and study plan

MARIE

Device

Portable mainstream capnography

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. Usability as reported by nurse.

    Time frame: During anesthesia and mechanical ventilation maximum up to 12 hours after start of anesthesia

  7. Reasons for premature termination of MARIE.

    Time frame: During anesthesia and mechanical ventilation maximum up to 12 hours after start of anesthesia

  8. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Malin Jonsson Fagerlund, Professor

CONTACT

[email protected]

+46 8 12372107

Sponsors and collaborators

Lead sponsor

Malin Jonsson Fagerlund

Other

Registry information

Acronym: NOVOCAP-Intub

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 14, 2026
Registry last updated
Sep 14, 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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