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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07816926
Acronym
NOVOCAP-Intub
Enrollment
30
Registered
2026-09-14
Start date
2026-09-07
Completion date
2026-12-31
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Capnography, Intubation, Monitoring

Keywords

capnography, monitoring, mainstream, novel

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.

Interventions

DEVICEMARIE

Portable mainstream capnography

Sponsors

Malin Jonsson Fagerlund
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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.During anesthesia and mechanical ventilationEnd-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

MeasureTime frame
Correlation of end-tidal CO₂ (EtCO₂) measurements between MARIE and Getinge Flow-iDuring 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
Usability as reported by nurse.During anesthesia and mechanical ventilation maximum up to 12 hours after start of anesthesia
Reasons for premature termination of MARIE.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.During anesthesia and mechanical ventilation maximum up to 12 hours after start of anesthesia

Contacts

CONTACTMalin Jonsson Fagerlund, Professor
malin.jonsson-fagerlund@regionstockholm.se+46 8 12372107

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 15, 2026