Automated Oxygen Administration Alleviates Dyspnea in Patients Admitted with Acute Exacerbation of COPD: A Randomized Controlled Trial

Abstract

Objective

Devices for Automated Oxygen Administration (AOA) have been developed to optimize the therapeutic benefit of oxygen supplementation. We aimed to investigate the effect of AOA on multidimensional aspects of dyspnea and as-needed consumption of opioids and benzodiazepines, as opposed to conventional oxygen therapy, in hospitalized patients with Acute Exacerbation of COPD (AECOPD).

Method and Patients

A multicenter randomized controlled trial across five respiratory wards in the Capital Region of Denmark. Patients admitted with AECOPD (n=157) were allocated 1:1 to either AOA (O2matic Ltd), a closed loop device automatically delivering oxygen according to the patient’s peripheral oxygen saturation (SpO₂), or conventional nurse-administered oxygen therapy. Oxygen flows and SpO₂ levels were measured by the O2matic device in both groups, while dyspnea, anxiety, depression, and COPD symptoms were accessed by Patient Reported Outcomes.

Results

Of the 157 randomized patients, 127 had complete data for the intervention. The AOA reduced patients’ perception of overall unpleasantness significantly on the Multidimensional Dyspnea Profile (MDP) with a difference in medians of −3 (p=0.003) between the intervention group (n=64) and the control group (n=63). The AOA also provided a significant between group difference in all single items within the sensory domain of the MDP (all p-values≤0.05) as well as in the Visual Analogue Scale – Dyspnea (VAS-D) within the past three days (p=0.013). All between group differences exceeded the Minimal Clinical Important Difference of the MDP and VAS-D, respectively. AOA did not seem to have an impact on the emotional response domain of the MDP, the COPD Assessment Test, the Hospital Anxiety and Depression Scale, or use of as-needed opioids and/or benzodiazepines (all p-values>0.05).

Conclusion

AOA reduces both breathing discomfort and physical perception of dyspnea in patients admitted with AECOPD but did not seem to impact the emotional status or other COPD symptoms.

Keywords:

• dyspnea
• oxygen
• automated oxygen therapy
• multidimensional dyspnea profile
• COPD
• hospital
• admission
• therapy

Data Sharing Statement

The authors will share all study data. However, we must comply to national and international data regulations to protect patient's right to own data. Thus, scientists can approach the corresponding author with a plan, and we will do every effort to help formulating the request within legislative frames.

Ethics Approval and Informed Consent

All patients involved in the study signed an informed consent approved by the Capital Regions’ Committee on Health Research Ethics (H-17040114).

Consent for Publication

All authors involved in the study gave consent for publication.

Acknowledgments

The authors kindly thank the patients participating in this study and the contributing hospital wards, especially Dr. Imane Achir Alispahic, Dr. Claire Præst Holm and RN Silvia Lau Henriksen for their engagements.

Author Contributions

All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.

Disclosure

O2matic Ltd has not been involved in the study. EFH is the main inventor of O2matic Ltd and a shareholder but has not been involved in data collection or analysis. The authors report no conflicts of interest in this work.

Additional information

Funding

We thank the Niels Christian Nielsen Foundation, Danish Lung Association and Copenhagen University Hospital Hvidovre for supporting and financing this study.