Respiratory Failure Clinical Trial
— O2MATICOfficial title:
Automated Oxygen Delivery by O2matic to Patients Admitted With an Exacerbation in COPD
NCT number | NCT03464695 |
Other study ID # | O2MATIC-COPD |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 7, 2018 |
Est. completion date | August 8, 2018 |
Verified date | January 2019 |
Source | Hvidovre University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 20 |
Est. completion date | August 8, 2018 |
Est. primary completion date | August 8, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 35 Years and older |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Gentofte University Hospital | Hellerup | |
Denmark | Hvidovre University Hospital | Hvidovre |
Lead Sponsor | Collaborator |
---|---|
Hvidovre University Hospital | Innovation Fund Denmark |
Denmark,
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. Review. — View Citation
Hansen EF, Hove JD, Bech CS, Jensen JS, Kallemose T, Vestbo J. Automated oxygen control with O2matic(®) 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. — View Citation
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. — View Citation
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). pii: 1602552. doi: 10.1183/13993003.02552-2016. Print 2017 Jul. — View Citation
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. — View Citation
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. Epub 2016 Oct 18. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time within SpO2-interval | Fraction of time where SpO2 is kept within desired interval (e.g. 88-92 %) relative to time with SpO2-signal. | 4 hours | |
Secondary | Time with severe hypoxia | Fraction of time where SpO2 is below 85 % relative to time with SpO2 signal | 4 hours | |
Secondary | Time with hypoxia | Fraction of time where SpO2 is below intended interval but not below 85 % relative to time with SpO2 signal | 4 hours | |
Secondary | Time with hyperoxia | Fraction of time where SpO2 is above intended interval relative to time with SpO2 signal | 4 hours |
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