NCT05452863

Brief Summary

Automatic oxygen supply with the O2matic device has been shown to provided an enhanced oxygen treatment in patients with hypoxemia. O2matic was significantly better than manual control to maintain oxygen saturation within target interval and to reduce time with unintended hypoxemia in patients suffering from chronic obstructive pulmonary disease. This trial investigates the effect of using O2matic in hypoxic patients submitted to the Department of Cardiology.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Typical duration for not_applicable

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

Study Start

First participant enrolled

March 1, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 4, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 11, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

1 year

First QC Date

July 4, 2022

Last Update Submit

September 18, 2024

Conditions

Heart Diseases

Keywords

hypoxemiacardiologyautomatic oxygen supply

Outcome Measures

Primary Outcomes (1)

  • Time in designated saturation interval

    We have predefined an optimum saturation interval of 92-96% with a target of 93%

    24 hours of treatment

Secondary Outcomes (3)

  • Time with hypoxemia

    24 hours of treatment

  • Time with severe hypoxemia

    24 hours of treatment

  • Time with hyperoxemia

    24 hours of treatment

Study Arms (2)

Automatic oxygen supply

ACTIVE COMPARATOR

Oxygen will be supplied by the O2matic device

Device: O2matic administered oxygen

Manual oxygen supply

PLACEBO COMPARATOR

Oxygen will be supplied by nurse adjustments in the usual way

Device: Manual oxygen supply and adjustments

Interventions

O2matic administered oxygenDEVICE

Oxygen supply is adjusted from an almost continuous measurement of the oxygen saturation with an appropriate an previously tested algorithm.

Automatic oxygen supply
Manual oxygen supply and adjustmentsDEVICE

Oxygen supply is adjusted from manual measurements of the oxygen saturation

Manual oxygen supply

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with heart disease and an oxygen saturation below 94% admitted to the Department of Cardiology
  • Age of 30 or more
  • Intellectual capacity to participate in the trial
  • Willing to give informed accept of participation in the trial.

You may not qualify if:

  • Unstable patients
  • Need for ventilatory support except intermittent continuous positive airway pressure
  • Fertile women (age\<55 years) with a positive pregnancy test
  • Unable to participate due to language or cognitive problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amager and Hvidovre Hospital University of Copenhagen

Copenhagen, DK-2650, Denmark

Location

Related Publications (5)

  • Hansen EF, Bech CS, Vestbo J, Andersen O, Kofod LM. Automatic oxygen titration with O2matic(R) to patients admitted with COVID-19 and hypoxemic respiratory failure. Eur Clin Respir J. 2020 Oct 14;7(1):1833695. doi: 10.1080/20018525.2020.1833695.

    PMID: 33144929BACKGROUND

  • Kofod LM, Westerdahl E, Kristensen MT, Brocki BC, Ringbaek T, Hansen EF. Effect of Automated Oxygen Titration during Walking on Dyspnea and Endurance in Chronic Hypoxemic Patients with COPD: A Randomized Crossover Trial. J Clin Med. 2021 Oct 20;10(21):4820. doi: 10.3390/jcm10214820.

    PMID: 34768338BACKGROUND

  • Hansen EF, Hove JD, Bech CS, Jensen JS, Kallemose T, Vestbo J. Automated oxygen control with O2matic(R) during admission with exacerbation of COPD. Int J Chron Obstruct Pulmon Dis. 2018 Dec 14;13:3997-4003. doi: 10.2147/COPD.S183762. eCollection 2018.

    PMID: 30587955RESULT

  • Taraldsen IA, Grand J, Lukoschewitz JD, Seven E, Dixen U, Petersen M, Rytoft L, Jakobsen MM, Hansen EF, Hove JD. Automated oxygen administration versus manual control in acute cardiovascular care: a randomised controlled trial. Heart. 2024 Dec 13;111(1):27-34. doi: 10.1136/heartjnl-2024-324488.

    PMID: 39486892DERIVED

  • Taraldsen IA, Grand J, Lukoschewitz JD, Hansen EF, Hove JD. Automated versus manual oxygen administration for patients admitted with acute cardiovascular disease - a study protocol of a randomised controlled trial. Dan Med J. 2023 Mar 27;70(4):A12220784.

    PMID: 36999819DERIVED

Related Links

MeSH Terms

Conditions

Heart DiseasesHypoxia

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jens D Hove, MD, PhD

    Amager-Hvidovre Universitetshospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized, open-label study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, MD, PhD

Study Record Dates

First Submitted

July 4, 2022

First Posted

July 11, 2022

Study Start

March 1, 2022

Primary Completion

March 18, 2023

Study Completion

March 18, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)