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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-28

Study Completion Date

2023-07-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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COPD Chronic Hypoxemic Respiratory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Manual

Fixed dose oxygen

Group Type ACTIVE_COMPARATOR

Oxygen concentrator

Intervention Type DEVICE

Fixed dose oxygen flow from concentrator

O2matic

Automated oxygen titration

Group Type EXPERIMENTAL

O2matic HOT

Intervention Type DEVICE

Automated oxygen titration with O2matic HOT

Interventions

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O2matic HOT

Automated oxygen titration with O2matic HOT

Intervention Type DEVICE

Oxygen concentrator

Fixed dose oxygen flow from concentrator

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No