NCT04606290

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Hvidovre University Hospital · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COPD
• Chronic Hypoxemic Respiratory Failure

Interventions

Type	Name	Description
DEVICE	O2matic HOT	Automated oxygen titration with O2matic HOT
DEVICE	Oxygen concentrator	Fixed dose oxygen flow from concentrator

Timeline

• Start date: 2020-10-28
• Primary completion: 2023-07-01
• Completion: 2023-07-01
• First posted: 2020-10-28
• Last updated: 2024-10-15

Locations

2 sites across 1 country: Denmark