An interventional study of O2matic in COPD Exacerbation, Hypoxia and Hyperoxia, sponsored by Hvidovre University Hospital. Completed at 2 sites in Denmark. Open to participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Hvidovre University Hospital · Not applicable, Interventional, and Treatment
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).
Closed-loop control of oxygen therapy is described in the literature used for preterm infants, trauma patients, medical emergency use and patients with COPD. For the latter, closed-loop therapy has been used for patients admitted to hospital with an exacerbation, for domiciliary oxygen use and during exercise. O2matic is a closed-loop system that is based on continuous and non-invasive measurement of pulse, oxygen-saturation and respiratory frequency. The algorithm in O2matic controls oxygen delivery with the aim of keeping the saturation within the desired interval, which could be 88-92 % for COPD-patients in accordance with international guidelines on this topic. Saturation interval can be set for the individual patients, as can the range of acceptable oxygen-flow. If saturation or oxygen-flow can't be maintained within the desired intervals an alarm will sound.
All studies on closed-loop systems have shown that this method is better than manually control by nurse to maintain saturation within the desired interval. Furthermore, some studies have indicated that closed-loop has the possibility to reduce admission time and to reduce time spent with oxygen therapy, due to more efficient and fast withdrawal from oxygen supplementation.
In the present study O2matic will be tested versus manual control, for patients admitted with an exacerbation in COPD, and in need of supplemental oxygen. During the study the patients will either have oxygen controlled with O2matic or manually by nursing staff. All patients will have continuous logging of pulse, oxygen-saturation and oxygen-flow with O2matic, but only in the O2matic active group, the algorithm will control oxygen-delivery.
The primary hypothesis will be tested, which is that O2matic is better than manual control for maintaining oxygen-saturation within the desired interval and reducing time with unintended hypoxia and hyperoxia. For this purpose 20 patients will be included in a crossover design with 4 hours of O2matic-controlled oxygen treatment and 4 hours with manually titrated oxygen with a 16 hours washout between periods.
No safety issues has been reported in the literature. Before use O2matic will be approved by The Danish Medicines Agency, The Ethics Committee in the Capital Region of Denmark and by the regional Data Protection Board. The study will be conducted according to GCP standards with independent monitoring. All adverse events and serious adverse events will be monitored and serious adverse events will be reported to Danish Medicines Agency.
1,076 studies on the registry are indexed under Hypoxia; 213 are open to participants now.
This study's enrollment of 20 is below the median of 45 across 769 interventional studies indexed under Hypoxia.
Browse Hypoxia studies →Hvidovre University Hospital is the lead sponsor of 299 studies on the registry; 20 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Oxygen administered by O2matic. Automatic adjustment based on continuous measurement of SpO2.
Device: O2matic
Oxygen administered by manual control based on nurse's intermittent measurement of SpO2.
Continous measurement of SpO2 during an admission with COPD, and closed-loop control of oxygen-delivery to maintain SpO2 within a target interval.
Time within SpO2-interval
Fraction of time where SpO2 is kept within desired interval (e.g. 88-92 %) relative to time with SpO2-signal.
Time frame: 4 hours
Time with severe hypoxia
Fraction of time where SpO2 is below 85 % relative to time with SpO2 signal
Time frame: 4 hours
Time with hypoxia
Fraction of time where SpO2 is below intended interval but not below 85 % relative to time with SpO2 signal
Time frame: 4 hours
Time with hyperoxia
Fraction of time where SpO2 is above intended interval relative to time with SpO2 signal
Time frame: 4 hours
Plan to share: No
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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