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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMalin Jonsson Fagerlund

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult, ≥18 years of age

Elective surgery under general anesthesia

Endotracheal intubation

Planned for arterial line

Disqualifiers

Unable to understand study information or sign the consent form

Trial design

Design model

Single group

Treatments tested in this trial

  • MARIE

    Device

    Portable mainstream capnography

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: MARIEExperimental treatment 1 intervention

Trial outcomes

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

Time frame
During anesthesia and mechanical ventilation

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Malin Jonsson Fagerlund

Lead sponsor

Karolinska University Hospital

Sponsor institution

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