Evaluation of a Novel Portable Mainstream Capnograph MARIE in Adult Intubated Patients. A Prospective Validation Study (NOVOCAP-Intub)
September 7, 2026 updated by: Malin Jonsson Fagerlund
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 Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Malin Jonsson Fagerlund, Professor
- Phone Number: +46 8 12372107
- Email: malin.jonsson-fagerlund@regionstockholm.se
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: MARIE
NOvel mainstream capnography
|
Portable mainstream capnography
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
During anesthesia and mechanical ventilation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
During anesthesia and mechanical ventilation maximum up to 12 hours after start of anesthesia
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 7, 2026
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
September 1, 2026
First Submitted That Met QC Criteria
September 7, 2026
First Posted (Actual)
September 14, 2026
Study Record Updates
Last Update Posted (Actual)
September 14, 2026
Last Update Submitted That Met QC Criteria
September 7, 2026
Last Verified
September 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- NOVOCAP-Intub
- CIV-26-07-059154 (Registry Identifier: CIV-ID)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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