COPD ExacerbationO2MATICNCT03464695
Automated Oxygen Delivery by O2matic to Patients Admitted With an Exacerbation in COPD
A study testing O2matic in people with COPD Exacerbation and Hypoxia, run by Hvidovre University Hospital at 2 sites in Denmark.
Trial 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). Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- COPD Exacerbation, Hypoxia, Hyperoxia
- What is being tested?
- O2matic
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesDenmark
- Study dates
- 7 May 2018to 8 Aug 2018
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Gentofte University Hospital
Hellerup, 2900
Hvidovre University Hospital
Hvidovre, 2650
About this study
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).
Read the detailed description
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.
- Conditions
- COPD Exacerbation, Hypoxia, Hyperoxia, Respiratory Failure, Respiratory Insufficiency, Copd Exacerbation Acute
- Being tested
- O2matic
- Keywords
- closed-loop, oxygen treatment
- Medical subject headings
- Hypoxia, Hyperoxia, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
O2maticDevice
Continous measurement of SpO2 during an admission with COPD, and closed-loop control of oxygen-delivery to maintain SpO2 within a target interval.
| Study group | Role | What they receive |
|---|---|---|
| O2matic | Active comparator | Oxygen administered by O2matic. Automatic adjustment based on continuous measurement of SpO2. Receives: Device: O2matic |
| Manual | No intervention | Oxygen administered by manual control based on nurse's intermittent measurement of SpO2. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time within SpO2-interval
Fraction of time where SpO2 is kept within desired interval (e.g. 88-92 %) relative to time with SpO2-signal.
Measured: 4 hours
Secondary outcomes (3)
Time with severe hypoxia
Fraction of time where SpO2 is below 85 % relative to time with SpO2 signal
Measured: 4 hours
Time with hypoxia
Fraction of time where SpO2 is below intended interval but not below 85 % relative to time with SpO2 signal
Measured: 4 hours
Time with hyperoxia
Fraction of time where SpO2 is above intended interval relative to time with SpO2 signal
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study start7 May 2018
- Primary completion8 Aug 2018
- Study completion8 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for COPD ExacerbationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Innovation Fund Denmark
- Responsible party
- Principal investigator, Ejvind Frausing Hansen, Hvidovre University Hospital
- Investigators
- Jørgen Vestbo, DMSc, Study chair, Manchester University HospitalEjvind Frausing Hansen, MD, Principal investigator, Hvidovre University Hospital, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03464695
- Sponsor's protocol ID
- O2MATIC-COPD
- Acronym
- O2MATIC
- Status last verified
- Sep 2026
- First submitted
- 2 Mar 2018
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Claure N, Bancalari E. Closed-loop control of inspired oxygen in premature infants. Semin Fetal Neonatal Med. 2015 Jun;20(3):198-204. doi: 10.1016/j.siny.2015.02.003. Epub 2015 Mar 12.
PubMed 25773271Johannigman JA, Branson R, Lecroy D, Beck G. Autonomous control of inspired oxygen concentration during mechanical ventilation of the critically injured trauma patient. J Trauma. 2009 Feb;66(2):386-92. doi: 10.1097/TA.0b013e318197a4bb.
PubMed 19204511L'Her E, Dias P, Gouillou M, Riou A, Souquiere L, Paleiron N, Archambault P, Bouchard PA, Lellouche F. Automatic versus manual oxygen administration in the emergency department. Eur Respir J. 2017 Jul 20;50(1):1602552. doi: 10.1183/13993003.02552-2016. Print 2017 Jul.
PubMed 28729473Lellouche F, Bouchard PA, Roberge M, Simard S, L'Her E, Maltais F, Lacasse Y. Automated oxygen titration and weaning with FreeO2 in patients with acute exacerbation of COPD: a pilot randomized trial. Int J Chron Obstruct Pulmon Dis. 2016 Aug 24;11:1983-90. doi: 10.2147/COPD.S112820. eCollection 2016.
PubMed 27601891Lellouche F, L'Her E, Bouchard PA, Brouillard C, Maltais F. Automatic Oxygen Titration During Walking in Subjects With COPD: A Randomized Crossover Controlled Study. Respir Care. 2016 Nov;61(11):1456-1464. doi: 10.4187/respcare.04406. Epub 2016 Oct 18.
PubMed 27794080Rice KL, Schmidt MF, Buan JS, Lebahn F, Schwarzock TK. AccuO2 oximetry-driven oxygen-conserving device versus fixed-dose oxygen devices in stable COPD patients. Respir Care. 2011 Dec;56(12):1901-5.
PubMed 22288082Hansen 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.
PubMed 30587955