Automated oxygen control with O2matic® during admission with exacerbation of COPD

Ejvind Frausing Hansen, Jens Dahlgaard Hove, Charlotte Sandau Bech, Jens-Ulrik Stæhr Jensen, Thomas Kallemose, Jørgen Vestbo, Ejvind Frausing Hansen, Jens Dahlgaard Hove, Charlotte Sandau Bech, Jens-Ulrik Stæhr Jensen, Thomas Kallemose, Jørgen Vestbo

Abstract

Purpose: It is a challenge to control oxygen saturation (SpO2) in patients with exacerbations of COPD during admission. We tested a newly developed closed-loop system, O2matic®, and its ability to keep SpO2 within a specified interval compared with manual control by nursing staff.

Patients and methods: We conducted a crossover trial with patients admitted with an exacerbation of COPD and hypoxemia (SpO2 ≤88% on room air). Patients were monitored with continuous measurement of SpO2. In random order, they had 4 hours with manually controlled oxygen and 4 hours with oxygen delivery controlled by O2matic. Primary outcome was time within a prespecified SpO2 target interval. Secondary outcomes were time with SpO2 <85%, time with SpO2 below target but not <85%, and time with SpO2 above target.

Results: Twenty patients were randomized and 19 completed the study. Mean age was 72.4 years and mean FEV1 was 0.72 L (33% of predicted). Patients with O2matic-controlled treatment were within the SpO2 target interval in 85.1% of the time vs 46.6% with manually controlled treatment (P<0.001). Time with SpO2 <85% was 1.3% with O2matic and 17.9% with manual control (P=0.01). Time with SpO2 below target but not <85% was 9.0% with O2matic and 25.0% with manual control (P=0.002). Time with SpO2 above target was not significantly different between treatments (4.6% vs 10.5%, P=0.2). Patients expressed high confidence and a sense of safety with automatic oxygen delivery.

Conclusion: O2matic was able to effectively control SpO2 for patients admitted with an exacerbation of COPD. O2matic was significantly better than manual control to maintain SpO2 within target interval and to reduce time with unintended hypoxemia.

Keywords: closed-loop; hyperoxia; hypoxia; oxygen saturation; oxygen therapy.

Conflict of interest statement

Disclosure EFH and JDH are co-inventors of O2matic® and both have participated in the development and testing of the device since 2011. The partnership, which was built during the development funded by Innovation Fund Denmark, formed a new company (O2matic Ltd., Herlev, Denmark) and both EFH and JDH participate as shareholders in O2matic Ltd. Jørgen Vestbo is supported by the NIHR Manchester Biomedical Research Center. The authors report no other conflicts of interest in this work.

Figures

Figure 1
Figure 1
The O2matic® device.
Figure 2
Figure 2
Study design.
Figure 3
Figure 3
Fraction of time with different levels of SpO2 for O2matic® (blue bars) and manual control (red bars). Abbreviation: SpO2, oxygen saturation.

References

    1. Global Initiative for Chronic Obstructive Lung Disease Global strategy for the diagnosis, management and prevention of COPD. 2018. [Accessed December 02, 2018]. Available from: .
    1. British Thoracic Society Emergency Oxygen Guideline Development Group BTS guideline for oxygen use in adults in healthcare and emergency settings. Thorax. 2017;72:i1–i90.
    1. Austin MA, Wills KE, Blizzard L, Walters EH, Wood-Baker R. Effect of high flow oxygen on mortality in chronic obstructive pulmonary disease patients in prehospital setting: randomised controlled trial. BMJ. 2010;341:c5462.
    1. Cameron L, Pilcher J, Weatherall M, Beasley R, Perrin K. The risk of serious adverse outcomes associated with hypoxaemia and hyperoxaemia in acute exacerbations of COPD. Postgrad Med J. 2012;88(1046):684–689.
    1. Lellouche F, Bouchard PA, Roberge M, et al. 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;11:1983–1990.
    1. L’Her E, Dias P, Gouillou M, et al. Automatic versus manual oxygen administration in the emergency department. Eur Respir J. 2017;50(1):1602552.
    1. Claure N, Gerhardt T, Everett R, Musante G, Herrera C, Bancalari E. Closed-loop controlled inspired oxygen concentration for mechanically ventilated very low birth weight infants with frequent episodes of hypoxemia. Pediatrics. 2001;107(5):1120–1124.
    1. Claure N, D’Ugard C, Bancalari E. Automated adjustment of inspired oxygen in preterm infants with frequent fluctuations in oxygenation: a pilot clinical trial. J Pediatr. 2009;155(5):640–645.
    1. Hallenberger A, Poets CF, Horn W, et al. Closed-loop automatic oxygen control (CLAC) in preterm infants: a randomized controlled trial. Pediatrics. 2014;133(2):e379–e385.
    1. Lal M, Tin W, Sinha S. Automated control of inspired oxygen in ventilated preterm infants: crossover physiological study. Acta Paediatr. 2015;104(11):1084–1089.
    1. Cirio S, Nava S. Pilot study of a new device to titrate oxygen flow in hypoxic patients on long-term oxygen therapy. Respir Care. 2011;56(4):429–434.
    1. 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;61(11):1456–1464.
    1. 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;56(12):1901–1905.
    1. Cousins JL, Wark PA, McDonald VM. Acute oxygen therapy: a review of prescribing and delivery practices. Int J Chron Obstruct Pulmon Dis. 2016;11:1067–1075.
    1. O’Driscoll BR. British Thoracic Society. Emergency oxygen audit. 2013. [Accessed August 15, 2018]. Available from:
    1. Pretto JJ, McDonald VM, Wark PA, Hensley MJ. Multicentre audit of inpatient management of acute exacerbations of chronic obstructive pulmonary disease: comparison with clinical guidelines. Intern Med J. 2012;42(4):380–387.
    1. Roberts CM, Lopez-Campos JL, Pozo-Rodriguez F, Hartl S, European COPD Audit team European hospital adherence to GOLD recommendations for chronic obstructive pulmonary disease (COPD) exacerbation admissions. Thorax. 2013;68(12):1169–1171.
    1. Abdo WF, Heunks LM. Oxygen-induced hypercapnia in COPD: myths and facts. Crit Care. 2012;16(5):323.

Source: PubMed

Sponsors and Collaborators

Medical Conditions

Drug Interventions

3
Subscribe