COPD ExacerbationO2MATIC-WEANNCT03661086
Oxygen Control and Weaning by O2matic to Patients Admitted With an Exacerbation of COPD
A study testing O2matic in people with COPD Exacerbation and Hypoxia, run by Hvidovre University Hospital at 5 sites in Denmark.
Trial summary
The aim of the study is to examine if automated oxygen delivery with O2matic allows for faster weaning from oxygen and better oxygen control than manually controlled oxygen therapy for patients admitted with an exacerbation of 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, Hypoxemia
- What is being tested?
- O2matic
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 5 sitesDenmark
- Study dates
- 1 Dec 2018to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Forced Expiratory Volume in 1. second (FEV1) divided by Forced Vital Capacity (FVC) < 0,70
- Admission due to exacerbation in COPD
- COPD exacerbation and pneumonia can be included
- Expected duration of admission > 48 hours
- Need for oxygen supplementation (SpO2 <= 88 % on room air)
- Cognitively able to participate in the study
- Willing to participate and give informed consent
Who cannot join
- Need or anticipated need for mechanical ventilation (intermittent Continuous Positive Airway Pressure (CPAP) is allowed)
- Major comorbidities causing hypoxemia (Cancer, heart disease, pulmonary emboli)
- Asthma or other respiratory condition requiring higher SpO2 than normal for COPD
- Pregnancy
- Cognitive barriers for participation
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Denmark5 sites
Bispebjerg University Hospital
Copenhagen, 2400
Nordsjællands Hospital
Frederikssund, 3600
Gentofte University Hospital
Hellerup, 2900
Herlev University Hospital
Herlev, 2730
Hvidovre University Hospital
Hvidovre, 2650
About this study
The aim of the study is to examine if automated oxygen delivery with O2matic allows for faster weaning from oxygen and better oxygen control than manually controlled oxygen therapy for patients admitted with an exacerbation of chronic obstructive pulmonary disease (COPD). Furthermore it will be tested if O2matic compared to manual control allows for faster discharge from hospital. Patients sense of security, anxiety and dyspnea will be evaluated by questionnaires.
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 and oxygen-saturation (SpO2). The algorithm in O2matic controls oxygen delivery with the aim of keeping the SpO2 within the desired interval, which could be 88-92 % for COPD-patients in accordance with international guidelines on this topic. SpO2-interval can be set for the individual patients, as can the range of acceptable oxygen-flow. If SpO2 or oxygen-flow cannot 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 for 3 consecutive days. 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 is that O2matic compared to manual control allows for faster weaning from oxygen supplementation, and that more patients will be weaned from oxygen supplementation within a time frame of 3 days. Furthermore it will be tested if O2matic compared to manual control leads to faster achieved respiratory stability, allowing for hospital discharge. It will be tested if O2matic is better than manual control in maintaining oxygen-saturation within the desired interval and reducing time with unintended hypoxia and hyperoxia. Patients sense of security and feeling of anxiety and dyspnea will be evaluated by questionnaires.
No safety issues has been reported in the literature. O2matic is approved for clinical testing 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 Good Clinical Practice (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, Hypoxemia, Hyperoxia, Respiratory Failure, Respiratory Insufficiency
- 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
O2matic controls oxygen with the aim of maintaining SpO2 within a predefined target interval, e.g. 88-92 % with the lowest possible supplementation of oxygen by nasal cannula
| Study group | Role | What they receive |
|---|---|---|
| O2matic | Active comparator | Usual care plus O2matic controlled oxygen therapy for a maximum of 3 days or until weaning from oxygen supplementation Receives: Device: O2matic |
| Manual | No intervention | Usual care plus manual controlled oxygen therapy by nursing staff. O2matic used in monitoring mode to measure SpO2 continuously. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to weaning from oxygen supplementation
Time to weaning from oxygen supplementation in O2matic and manual arm (Patients will be followed for this outcome during the admission, up to 30 days)
Measured: 30 days
Secondary outcomes (10)
Number of patients weaned from oxygen supplementation after day 1
Fraction of patients weaned from oxygen supplementation after 1 day in O2matic and manual arm
Measured: 1 day
Number of patients weaned from oxygen supplementation after day 3
Fraction of patients weaned from oxygen supplementation after 3 days in O2matic and manual arm
Measured: 3 days
Time within SpO2 interval
Fraction of time within prescribed SpO2 interval in O2matic and manual arm
Measured: 3 days
Time with severe hypoxemia
Fraction of time with SpO2 < 85 % in O2matic and manual arm
Measured: 3 days
Time with minor hypoxemia
Fraction of time with SpO2 below target but not below 85 % in O2matic and manual arm
Measured: 3 days
Time with hyperoxia
Fraction of time with SpO2 above target in O2matic and manual arm
Measured: 3 days
Sensation of safety
Patients sensation of safety measured by Visual Analog Scale (VAS) score in O2matic and manual arm
Measured: 3 days
Sensation of anxiety
Patients sensation of anxiety measured by Hospital Anxiety and Depression (HADS-A ) subscale in O2matic and manual arm
Measured: 3 days
Sensation of dyspnea
Patients sensation of dyspnea measured by Multidimensional Dyspnea Profile (MDP) in O2matic and manual arm
Measured: 3 days
Time to discharge
Time from admission to discharge from hospital
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start1 Dec 2018
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
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
- Parallel groups
- Model description
- Open label randomized controlled parallel study
- Masking
- None (open label)
- Enrolment
- 157 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 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03661086
- Sponsor's protocol ID
- O2MATIC-O2WEAN
- Acronym
- O2MATIC-WEAN
- Status last verified
- Sep 2022
- First submitted
- 1 Sep 2018
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rice 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 22288082Cirio S, Nava S. Pilot study of a new device to titrate oxygen flow in hypoxic patients on long-term oxygen therapy. Respir Care. 2011 Apr;56(4):429-34. doi: 10.4187/respcare.00983. Epub 2011 Jan 21.
PubMed 21255511Lellouche F, L'her E. Automated oxygen flow titration to maintain constant oxygenation. Respir Care. 2012 Aug;57(8):1254-62. doi: 10.4187/respcare.01343. Epub 2012 Feb 17.
PubMed 22348812Lellouche 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 27794080L'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 28729473Hansen 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
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxygen Control and Weaning by O2matic to Patients Admitted With an Exacerbation of COPD
- ClinicalTrials.gov ID
- NCT03661086
- Acronym / sponsor ID
- O2MATIC-WEAN / O2MATIC-O2WEAN
- Conditions
- COPD Exacerbation, Hypoxia, Hypoxemia, Hyperoxia, Respiratory Failure, Respiratory Insufficiency
- Keywords
- closed-loop, oxygen treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- Innovation Fund Denmark
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 7 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to examine if automated oxygen delivery with O2matic allows for faster weaning from oxygen and better oxygen control than manually controlled oxygen therapy for patients admitted with an exacerbation of chronic obstructive pulmonary disease (COPD). Furthermore it will be tested if O2matic compared to manual control allows for faster discharge from hospital. Patients sense of security, anxiety and dyspnea will be evaluated by questionnaires.
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 and oxygen-saturation (SpO2). The algorithm in O2matic controls oxygen delivery with the aim of keeping the SpO2 within the desired interval, which could be 88-92 % for COPD-patients in accordance with international guidelines on this topic. SpO2-interval can be set for the individual patients, as can the range of acceptable oxygen-flow. If SpO2 or oxygen-flow cannot 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 for 3 consecutive days. 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 is that O2matic compared to manual control allows for faster weaning from oxygen supplementation, and that more patients will be weaned from oxygen supplementation within a time frame of 3 days. Furthermore it will be tested if O2matic compared to manual control leads to faster achieved respiratory stability, allowing for hospital discharge. It will be tested if O2matic is better than manual control in maintaining oxygen-saturation within the desired interval and reducing time with unintended hypoxia and hyperoxia. Patients sense of security and feeling of anxiety and dyspnea will be evaluated by questionnaires.
No safety issues has been reported in the literature. O2matic is approved for clinical testing 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 Good Clinical Practice (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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label randomized controlled parallel study
| Arm | Type | Receives |
|---|---|---|
| O2matic | Active comparator | Device: O2maticUsual care plus O2matic controlled oxygen therapy for a maximum of 3 days or until weaning from oxygen supplementation |
| Manual | No intervention | –Usual care plus manual controlled oxygen therapy by nursing staff. O2matic used in monitoring mode to measure SpO2 continuously. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- COPD verified by Forced Expiratory Volume in 1. second (FEV1) divided by Forced Vital Capacity (FVC) < 0,70
- Admission due to exacerbation in COPD
- COPD exacerbation and pneumonia can be included
- Expected duration of admission > 48 hours
- Need for oxygen supplementation (SpO2 <= 88 % on room air)
Key exclusion criteria (5 listed)
- Need or anticipated need for mechanical ventilation (intermittent Continuous Positive Airway Pressure (CPAP) is allowed)
- Major comorbidities causing hypoxemia (Cancer, heart disease, pulmonary emboli)
- Asthma or other respiratory condition requiring higher SpO2 than normal for COPD
- Pregnancy
- Cognitive barriers for participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| O2maticO2matic controls oxygen with the aim of maintaining SpO2 within a predefined target interval, e.g. 88-92 % with the lowest possible supplementation of oxygen by nasal cannula | Device | O2matic |
Primary outcome
Time to weaning from oxygen supplementation
Time frame: 30 days
Time to weaning from oxygen supplementation in O2matic and manual arm (Patients will be followed for this outcome during the admission, up to 30 days)
10 secondary outcomes
Number of patients weaned from oxygen supplementation after day 1
Time frame: 1 day
Number of patients weaned from oxygen supplementation after day 3
Time frame: 3 days
Time within SpO2 interval
Time frame: 3 days
Time with severe hypoxemia
Time frame: 3 days
Time with minor hypoxemia
Time frame: 3 days
Time with hyperoxia
Time frame: 3 days
Sensation of safety
Time frame: 3 days
Sensation of anxiety
Time frame: 3 days
Sensation of dyspnea
Time frame: 3 days
Time to discharge
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Background: PubMed 22288082Rice 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.
- Background: PubMed 21255511Cirio S, Nava S. Pilot study of a new device to titrate oxygen flow in hypoxic patients on long-term oxygen therapy. Respir Care. 2011 Apr;56(4):429-34. doi: 10.4187/respcare.00983. Epub 2011 Jan 21.
- Background: PubMed 22348812Lellouche F, L'her E. Automated oxygen flow titration to maintain constant oxygenation. Respir Care. 2012 Aug;57(8):1254-62. doi: 10.4187/respcare.01343. Epub 2012 Feb 17.
- Background: PubMed 27601891Lellouche 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.
- Background: PubMed 27794080Lellouche 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.
- Background: PubMed 28729473L'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.
- Background: PubMed 30587955Hansen 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.
- Background and description of the O2matic deviceLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jørgen Vestbo, DMSc study chair
Manchester University Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing O2matic in people with COPD Exacerbation and Hypoxia, run by Hvidovre University Hospital at 5 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to weaning from oxygen supplementation (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03661086, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2022.