MedTrace Logo

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

NCT04375917 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 157

Last updated 2022-10-26

No results posted yet for this study

Summary

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 administered oxygen can be a better method of treating and alleviating dyspnoea.

Conditions

Interventions

DEVICE

O2matic

O2matic is a closed-loop-system that controls oxygenadministration according to SpO2. The aim is to maintain SpO2 within a predefined target interval, E.G. 88-92% with the lowest possible supplementation of oxygen by nasal cannula

Sponsors & Collaborators

  • Copenhagen University Hospital, Hvidovre

    lead OTHER

Principal Investigators

  • charlotte Sandau Bech, MScHS · Hvidovre University Hospital, Kettegaard alle

  • Thomas Jørgen Ringbæk, PhD, associated professor · Hvidovre University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2022-05-01
Completion
2022-10-01

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04375917 on ClinicalTrials.gov