NCT04370990

Automated Oxygen Administration -Rethinking Interventions Alleviating Dyspnea in Patients With COPD

Completed NA Last updated 26 October 2022

What this trial tests

NA trial testing O2matic in COPD in 157 participants. Completed in 1 May 2022.

Timeline

1 September 2019

Primary endpoint
1 May 2022

1 May 2022

Quick facts

Lead sponsor	Copenhagen University Hospital, Hvidovre
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	157
Start date	1 September 2019
Primary completion	1 May 2022
Estimated completion	1 May 2022
Sites	5 locations across Denmark

Drugs / interventions tested

• O2matic

Conditions studied

• COPD — all drugs for COPD →
• Hypoxia — all drugs for Hypoxia →
• Closed-Loop Communication — all drugs for Closed-Loop Communication →
• Dyspnea — all drugs for Dyspnea →

Sponsor

Copenhagen University Hospital, Hvidovre

Who can join

35 and older, any sex, with COPD or Hypoxia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Chronic Obstructive Pulmonary Disease (COPD) is associated with high morbidity and mortality. The Danish Lung Association estimates that 320,000 Danes live with COPD, of which approximately 50,000 with severe COPD. In 2017, records showed that 23,979 admissions in Denmark were related to COPD; of these patients, about 20% were readmitted 2-30 days after discharge. The main symptom is dyspnea, which is often accompanied by anxiety. Primary treatment is; oxygen, bronchiolitis, prednisolone, morfica, NIV, and anxiolytics.

Researchers at Hvidovre Hospital have developed an oxygen robot that continuously monitors the patient's SaO2 (oxygen saturation) and automatically administrates the oxygen depending on it. The preliminary results show that patients with robot-administrated oxygen were within defined SaO2 range in 85.7% of the time versus 46.6% when oxygen was nurse-administrated. The research was conducted as a multicentre Randomized Controlled Trial focusing on physiological end-points.

There is a lack of knowledge about the patient perspective of treatment with the oxygen robot.

The purpose of this study is:

1\. To examine the effect of robot-administered oxygen on patients' perception of dyspnoea, including the emotional response in the form of anxiety and depression

The perspective is to be able to provide a holistic response to whether robot-administered oxygen can be a better method of treating and alleviating dyspnoea.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Automated Oxygen Administration Alleviates Dyspnea in Patients Admitted with Acute Exacerbation of COPD: A Randomized Controlled Trial.
   Sandau C, Hansen EF, Ringbæk TJ, Kallemose T, et al · · 2023 · cited 13× · PMID 37096159 · DOI 10.2147/copd.s397782