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Automated Oxygen Titration with O2matic Home Oxygen Therapy (O2matic HOT) Phase 1 | Clinical Trials | Clareo Health

TERMINATEDNA

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

Automated Oxygen Titration to Patients with COPD and Domiciliary Long-term Oxygen Treatment

NCT04606290•Hvidovre University Hospital

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.

Detailed 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.

Eligibility

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (2)

Hvidovre University Hospital

Hvidovre, Denmark

Næstved University Hospital

Næstved, Denmark

Key Dates

Start Date

October 28, 2020

Primary Completion Date

July 1, 2023

Completion Date

July 1, 2023

Last Updated

October 15, 2024

Enrollment

ACTUAL participants

Conditions

COPDChronic Hypoxemic Respiratory Failure

Interventions

O2matic HOT

DEVICE

Oxygen concentrator

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 15, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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