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

Hvidovre University Hospital10 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

COPD Chronic Hypoxemic Respiratory Failure

Interventions

O2matic HOTDEVICE

Automated oxygen titration with O2matic HOT

Oxygen concentratorDEVICE

Fixed dose oxygen flow from concentrator

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Percentage of time in intended SpO2-interval

Percentage of time with SpO2 in intended interval

Time frame: 24 hours

Secondary Outcomes

Percentage of time with SpO2 below 85 %

Time frame: 24 hours

Percentage of time with SpO2 below target but not below 85 %

Time frame: 24 hours

Percentage of time with SpO2 above target

Time frame: 24 hours

Change in PaCO2 from baseline

Change in PaCO2 from baseline to 8 hours

Time frame: 8 hours

Change in PaCO2 from baseline

Change in PaCO2 from baseline to 24 hours

Time frame: 24 hours

Accumulated oxygen usage

Accumulated oxygen usage in 24 hours

Time frame: 24 hours

Adverse and serious adverse events

Adverse and serious adverse events, such as respiratory acidosis

Time frame: 24 hours

Data from ClinicalTrials.gov

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