Automated Oxygen Titration with O2matic Home Oxygen Therapy (O2matic HOT) Phase 1 (O2matic-HOT1)

Hvidovre University Hospital

Status: Terminated

Conditions: Chronic Hypoxemic Respiratory Failure; COPD

Treatments: Device: O2matic HOT; Device: Oxygen concentrator

Study type: Interventional

Funder types: Other

Identifiers

NCT04606290

O2matic-HOT1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 40+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

10 participants in 2 patient groups

Manual

Active Comparator group

Description:

Fixed dose oxygen

Treatment:

Device: Oxygen concentrator

O2matic

Experimental group

Description:

Automated oxygen titration

Treatment:

Device: O2matic HOT