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Is Reduced Hypoxia Through a Robot Intervention, Associated With Sensory and Emotional Descriptions of Dyspnea, Anxiety, Depression, Symptom Burden and Anxiolytics

NCT04375917 · Copenhagen University Hospital, Hvidovre · Updated 26 Oct 2022

What is being tested
O2matic
For
COPD; Dyspnea; Anxiety; Depressive Symptoms; Hypoxia; Closed-Loop Communication
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 35 years and older. About 157 people. The full rules are on the registry page.
Where
Denmark (5 sites)
When
Starts or started 1 Sept 2019, ends 1 Oct 2022. Registered 6 May 2020.
Results
None posted yet.

In the researchers' words

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, morfin, 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 (RCT)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 association between robot-administered oxygen and 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…
ClinicalTrials.gov, NCT04375917

Sites

  • Bispebjerg University HospitalCopenhagen, Denmark
  • Hvidovre University HospitalCopenhagen, Denmark
  • Herlev University HospitalCopenhagen, Denmark
  • Gentofte University HospitalCopenhagen, Denmark
  • Nordsjællands HospitalFrederikssund, Denmark