Can a machine breathe better than a nurse? automated oxygen system tested in COPD

NCT ID NCT03464695

Disease control Sponsor: Hvidovre University Hospital Source: ClinicalTrials.gov ↗

First seen Sep 09, 2026 · Last updated Sep 10, 2026 · Updated 1 time

Summary

Researchers are testing whether an automated oxygen delivery system called O2matic keeps blood oxygen levels in a safe range better than manual adjustment for patients hospitalized with a COPD flare-up. The device continuously measures oxygen saturation and uses an algorithm to control oxygen flow. The trial enrolls 20 adults who need oxygen and are admitted for more than 48 hours. The main question is whether O2matic increases the time spent within the target oxygen range and reduces periods of severe low oxygen or too much oxygen.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: O2matic, an automated closed-loop oxygen delivery device
What this could lead to: If it works, hospitals could use automated oxygen systems to keep COPD patients' oxygen levels steadier and reduce dangerous highs and lows.
What could go wrong: This is a small, early study of 20 patients at one hospital. The device may not outperform manual oxygen control, and results may not apply to sicker patients or other hospitals.

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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.

chronic obstructive pulmonary disease 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

Can a machine breathe better than a nurse? automated oxygen system tested in COPD

What the study statuses mean