Automated Oxygen Titration With O2matic Home Oxygen Therapy (O2matic HOT) Phase 1

  • STATUS
    Recruiting
  • days left to enroll
    38
  • participants needed
    15
  • sponsor
    Hvidovre University Hospital
Updated on 8 January 2022

Summary

O2matic HOT is a further development of O2matic and is intended for home oxygen use with patients in need of long-term oxygen treatment (LTOT). O2matic HOT is a closed-loop system which on basis of signals from pulse oximetry titrates the oxygen flow to the patient. In this crossover trial patients are admitted for 24 hours twice. Once with usual fixed dose oxygen and once with oxygen titration by O2matic HOT.

Description

The purpose of this study is to examine if automated oxygen control based on pulse oximetry to patients with domiciliary long-term oxygen treatment (LTOT) is better than manually controlled oxygen treatment in keeping SpO2 within intended target interval. In manually controlled oxygen treatment flow is usually kept constant for months between visits from specialist nurse, whereas in automated control the patient can titrate oxygen flow several times a day based on pulse oximetry in a closed-loop system.

Details
Condition COPD, Chronic Hypoxemic Respiratory Failure
Treatment O2matic HOT, Oxygen concentrator
Clinical Study IdentifierNCT04606290
SponsorHvidovre University Hospital
Last Modified on8 January 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Verified COPD with FEV1/FVC < 0.70
Need of LTOT (PaO2 <= 7.3 kPa or SpO2 < 88 % on ambient air)
Cognitively able to participate
Willing to provide informed consent

Exclusion Criteria

Moderate or severe exacerbation in COPD within 4 weeks from study start
Major comorbidities (cancer, uncontrolled chronic disease)
Asthma or other disease with need of higher SpO2
Pregnancy
Fall in pH below 7.35 or increase in PaCO2 > 1 kPa on 5 liters of oxygen
Active smoking
LTOT use less than 1 hours/day
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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