Oxygen Control and Weaning by O2matic to Patients Admitted With an Exacerbation of COPD (O2MATIC-WEAN)
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| ClinicalTrials.gov Identifier: NCT03661086 |
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Recruitment Status :
Recruiting
First Posted : September 7, 2018
Last Update Posted : December 29, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| COPD Exacerbation Hypoxia Hypoxemia Hyperoxia Respiratory Failure Respiratory Insufficiency Copd Exacerbation Acute | Device: O2matic | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 300 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Open label randomized controlled parallel study |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Oxygen Control and Weaning by O2matic to Patients Admitted With an Exacerbation of COPD |
| Actual Study Start Date : | December 1, 2018 |
| Estimated Primary Completion Date : | June 30, 2022 |
| Estimated Study Completion Date : | June 30, 2022 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: O2matic
Usual care plus O2matic controlled oxygen therapy for a maximum of 3 days or until weaning from oxygen supplementation
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Device: O2matic
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 |
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No Intervention: Manual
Usual care plus manual controlled oxygen therapy by nursing staff. O2matic used in monitoring mode to measure SpO2 continuously.
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- 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)
- Number of patients weaned from oxygen supplementation after day 1 [ Time Frame: 1 day ]Fraction of patients weaned from oxygen supplementation after 1 day in O2matic and manual arm
- Number of patients weaned from oxygen supplementation after day 3 [ Time Frame: 3 days ]Fraction of patients weaned from oxygen supplementation after 3 days in O2matic and manual arm
- Time within SpO2 interval [ Time Frame: 3 days ]Fraction of time within prescribed SpO2 interval in O2matic and manual arm
- Time with severe hypoxemia [ Time Frame: 3 days ]Fraction of time with SpO2 < 85 % in O2matic and manual arm
- Time with minor hypoxemia [ Time Frame: 3 days ]Fraction of time with SpO2 below target but not below 85 % in O2matic and manual arm
- Time with hyperoxia [ Time Frame: 3 days ]Fraction of time with SpO2 above target in O2matic and manual arm
- Sensation of safety [ Time Frame: 3 days ]Patients sensation of safety measured by Visual Analog Scale (VAS) score in O2matic and manual arm
- Sensation of anxiety [ Time Frame: 3 days ]Patients sensation of anxiety measured by Hospital Anxiety and Depression (HADS-A ) subscale in O2matic and manual arm
- Sensation of dyspnea [ Time Frame: 3 days ]Patients sensation of dyspnea measured by Multidimensional Dyspnea Profile (MDP) in O2matic and manual arm
- Time to discharge [ Time Frame: 30 days ]Time from admission to discharge from hospital
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| Ages Eligible for Study: | 35 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03661086
| Contact: Ejvind Frausing Hansen, MD | +45 3862 3233 | ejvind.frausing.hansen@regionh.dk |
| Denmark | |
| Bispebjerg University Hospital | Recruiting |
| Copenhagen, Denmark, 2400 | |
| Contact: Lars Pedersen, PhD +45 3863 6177 lars.pedersen.03@regionh.dk | |
| Nordsjællands Hospital | Suspended |
| Frederikssund, Denmark, 3600 | |
| Gentofte University Hospital | Recruiting |
| Hellerup, Denmark, 2900 | |
| Contact: Jens Ulrik Stæhr Jensen, PhD jens.ulrik.jensen@regionh.dk | |
| Contact: Imane Achir, MD imane.achir.01@regionh.dk | |
| Herlev University Hospital | Recruiting |
| Herlev, Denmark, 2730 | |
| Contact: Peter Lange, DMSc peter.lange@ku.sund.dk | |
| Contact: Merete Dall, RN merete.dall@regionh.dk | |
| Hvidovre University Hospital | Recruiting |
| Hvidovre, Denmark, 2650 | |
| Contact: Ejvind Frausing Hansen, MD +45 3862 3233 ejvind.frausing.hansen@regionh.dk | |
| Contact: Charlotte Sandau Bech, RN +45 2127 7711 charlotte.sandau.bech@regionh.dk | |
| Study Chair: | Jørgen Vestbo, DMSc | Manchester University Hospital |
Publications:
| Responsible Party: | Ejvind Frausing Hansen, Senior Consultant, Hvidovre University Hospital |
| ClinicalTrials.gov Identifier: | NCT03661086 |
| Other Study ID Numbers: |
O2MATIC-O2WEAN |
| First Posted: | September 7, 2018 Key Record Dates |
| Last Update Posted: | December 29, 2021 |
| Last Verified: | December 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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closed-loop oxygen treatment |
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Pulmonary Disease, Chronic Obstructive Respiratory Insufficiency Pulmonary Valve Insufficiency Hypoxia Hyperoxia Lung Diseases, Obstructive Lung Diseases |
Respiratory Tract Diseases Respiration Disorders Signs and Symptoms, Respiratory Heart Valve Diseases Heart Diseases Cardiovascular Diseases |