NCT07178236

Brief Summary

Postoperative respiratory complications are common and sometimes hard to detect early. Desaturation is a late sign of reduced minute ventilation, especially if the patient is on supplemental oxygen, and measurement of arterial or endtidal CO2 will rapidly detect a reduction in minute ventilation. Capnography offers a non-invasive and continuous measure of end-tidal expiratory pressure of carbon dioxide (EtCO2). Capnography is not a standard in postoperative care but rather quite rare. In the present study we evaluate a novel portable capnography device, MARIE, in postoperative patients.

  1. 1.The primary outcome is to describe the correlation of end-tidal CO₂ (EtCO₂) measurements between MARIETM (Oxlantics Medical) and Philips Intelli Vue X3 Microstream.
  2. 2.Secondary outcomes include
  3. 3.Correlation between PaCO₂ and EtCO₂ measured by MARIE and Philips Intelli Vue X3 Microstream, respectively.
  4. 4.Time trajectories of PaCO₂ and EtCO₂ measured using MARIE and Philips Intelli Vue X3 Microstream, respectively
  5. 5.The overall agreement between the EtCO2 measured by MARIE and Philips Intelli Vue X3 Microstream and PaCO2
  6. 6.Respiratory rate measured by MARIE compared to manual counting and Philips Intelli Vue X3.
  7. 7.Comparison of oxygen flow by MARIE and the rotameter.
  8. 8.Comfort as reported by patient.
  9. 9.Usability as reported by nurse.
  10. 10.Reasons for premature termination of MARIE
  11. 11.Registration of technical problems, for example unexpected shut downs and blockage by mucus.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for not_applicable surgery

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable surgery

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 17, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

September 22, 2025

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2025

Completed
Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

23 days

First QC Date

September 6, 2025

Last Update Submit

January 17, 2026

Conditions

SurgeryAnesthesiaPostoperative CareRespiration Rate DetectionCapnographyMonitoring

Keywords

capnographyPostoperativesurgeryanaesthesiamonitoringrespirationnovel equipment

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint is correlation of end-tidal CO₂ (EtCO₂) measurements between MARIETM (Oxlantics Medical) and Philips Intelli Vue X3 Microstream

    End-tidal CO₂ (EtCO₂) measurements will be measured by MARIE (Oxlantic Medical AB) and Philips Intelli Vue X3 Microstream at several occasions and thereafter correlated

    From enrolment to discharge from the postoperative unit or maximum 24 hours

Secondary Outcomes (8)

  • Correlation between PaCO₂ and EtCO₂ measured by MARIE and Philips Intelli Vue X3 Microstream, respectively.

    From enrolment in the study until discharge from the postoperative unit or maximum 24 hours

  • Time trajectories of PaCO₂ and EtCO₂ measured using MARIE and Philips Intelli Vue X3 Microstream, respectively

    From enrolment until discharge from the postoperative unit or maximum of 24 hours

  • The overall agreement between the EtCO2 measured by MARIE and Philips Intelli Vue X3 Microstream and PaCO2

    From enrolment until discharge from the postoperative unit or a maximum of 24 hours

  • Respiratory rate measured by MARIE compared to manual counting and Philips Intelli Vue X3

    From the enrolment in the study and until discharge from the postoperative unit or a maximum of 24 hours

  • Comparison of oxygen flow by MARIE and the rotameter

    From enrolment in the study until discharge from the postoperative unit or a maximum of 24 hours

  • +3 more secondary outcomes

Study Arms (1)

MARIE

EXPERIMENTAL

Portable capnograph

Device: MARIE

Interventions

MARIEDEVICE

Portable capnoghraphy

MARIE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult, ≥18 years of age
  • Elective surgery under general anesthesia
  • Planned for over night postoperative care

You may not qualify if:

  • Tracheostomy
  • Nasal obstruction
  • Rhino- or oral surgery
  • Not able to understand study information or signing consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital

Stockholm, 17176, Sweden

Location

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Malin Jonsson Fagerlund, Professor

    Karolinska University Hospital & Karolinska Institutet

    PRINCIPAL INVESTIGATOR

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 6, 2025

First Posted

September 17, 2025

Study Start

September 22, 2025

Primary Completion

October 15, 2025

Study Completion

December 22, 2025

Last Updated

January 21, 2026

Record last verified: 2026-01

Locations

SE(1)