Evaluation of a Novel Portable Mainstream Capnograph MARIE in Adult Intubated Patients. A Prospective Validation Study
NOVOCAP-Intub
2 other identifiers
interventional
30
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2026
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 1, 2026
CompletedStudy Start
First participant enrolled
September 7, 2026
CompletedFirst Posted
Study publicly available on registry
September 14, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
September 14, 2026
September 1, 2026
4 months
September 1, 2026
September 7, 2026
Conditions
Keywords
Outcome Measures
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.
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 Outcomes (8)
Correlation of end-tidal CO₂ (EtCO₂) measurements between MARIE and Getinge Flow-i
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.
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.
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.
During anesthesia and mechanical ventilation maximum up to 12 hours after start of anesthesia
Respiratory rate measured by MARIE compared to Getinge Flow-i.
During anesthesia and mechanical ventilation maximum up to 12 hours after start of anesthesia
- +3 more secondary outcomes
Study Arms (1)
MARIE
EXPERIMENTALNOvel mainstream capnography
Interventions
Eligibility Criteria
You may qualify if:
- Adult, ≥18 years of age
- Elective surgery under general anesthesia
- Endotracheal intubation
- Planned for arterial line
You may not qualify if:
- Unable to understand study information or sign the consent form
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 1, 2026
First Posted
September 14, 2026
Study Start
September 7, 2026
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
September 14, 2026
Record last verified: 2026-09