Automated Oxygen Delivery by O2matic to Patients Admitted With an Exacerbation in COPD
NCT ID: NCT03464695
Last Updated: 2019-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2018-05-07
2018-08-08
Brief Summary
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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).
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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O2matic
Oxygen administered by O2matic. Automatic adjustment based on continuous measurement of SpO2.
O2matic
Continous measurement of SpO2 during an admission with COPD, and closed-loop control of oxygen-delivery to maintain SpO2 within a target interval.
Manual
Oxygen administered by manual control based on nurse's intermittent measurement of SpO2.
No interventions assigned to this group
Interventions
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O2matic
Continous measurement of SpO2 during an admission with COPD, and closed-loop control of oxygen-delivery to maintain SpO2 within a target interval.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
35 Years
ALL
No
Sponsors
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Innovation Fund Denmark
INDIV
Hvidovre University Hospital
OTHER
Responsible Party
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Ejvind Frausing Hansen
Chief Physician
Principal Investigators
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Jørgen Vestbo, DMSc
Role: STUDY_CHAIR
Manchester University Hospital
Ejvind Frausing Hansen, MD
Role: PRINCIPAL_INVESTIGATOR
Hvidovre University Hospital, Copenhagen
Locations
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Gentofte University Hospital
Hellerup, , Denmark
Hvidovre University Hospital
Hvidovre, , Denmark
Countries
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References
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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.
Johannigman 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.
L'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.
Lellouche 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.
Lellouche 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.
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.
Hansen 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.
Related Links
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Open access to paper with results in Int J Chron Obstruct Pulmon Dis
Other Identifiers
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O2MATIC-COPD
Identifier Type: -
Identifier Source: org_study_id
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