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Automated oxygen delivery by O2matic to patients admitted with an exacerbation in COPD

NCT ID NCT03464695

NEW Sponsor: Hvidovre University Hospital Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 09, 2026 · Last updated Sep 09, 2026

Summary

The aim of the study is to examine if automated oxygen delivery with O2matic is better than manually controlled oxygen therapy for patients admitted to hospital with an exacerbation in Chronic Obstructive Pulmonary Disease (COPD). O2matic is a closed -loop system based on continuous non-invasive measurement of pulse and oxygen-saturation that is processed in an algorithm that controls the flow of oxygen to the patient. The primary hypothesis is that O2matic increases time within acceptable oxygen-saturation interval. Secondary hypotheses are that O2matic compared to manual control reduces time with severe hypoxia (SpO2 \< 85 %), hypoxi (SpO2 below intended interval) and hyperoxia (SpO2 above intended interval).

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

20 people

The number who actually took part.

Started

May 2018

Finished

Aug 2018

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

35 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * COPD verified by FEV1/FVC \< 0,70 * Admission due to exacerbation in COPD * COPD exacerbation and pneumonia can be included * Duration of admission \> 48 hours * Need for oxygen supplementation at inclusion (SpO2 \<= 88 % without O2 suppl.) * Cognitively able to participate in the study * Willing to participate and give informed consent. Exclusion Criteria: * Need or anticipated need for mechanical ventilation (except intermittent CPAP) * Major co-morbidities (cancer, heart disease, thromboembolic disease, uncontrolled diabetes) * Asthma or other respiratory condition requiring higher SpO2 than normal for COPD- patients * Pregnancy * Acute thromboembolic disease (\< 2 weeks) * Cognitive barriers for participation

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Conditions

The condition(s) this trial relates to.

Hyperoxia Hypoxia respiratory failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

COPD exacerbation COPD exacerbation acute Hyperoxia Hypoxia Respiratory failure Respiratory insufficiency

Contacts and locations

Locations

  • Gentofte University Hospital

    Hellerup, 2900, Denmark

  • Hvidovre University Hospital

    Hvidovre, 2650, Denmark

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