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

Not Applicable

Terminated

• Conditions: COPD; Chronic Hypoxemic Respiratory Failure
• Interventions: Device: O2matic HOT; Device: Oxygen concentrator

• Registration Number: NCT04606290
• Lead Sponsor: Hvidovre University Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2020-10-24
• Study First Submitted QC: 2020-10-24
• Study Start: 2020-10-28
• Study First Posted: 2020-10-28
• Primary Completion: 2023-07-01
• Study Completion: 2023-07-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-10
• Last Update Posted: 2024-10-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
O2matic	O2matic HOT	Automated oxygen titration
Manual	Oxygen concentrator	Fixed dose oxygen

Primary Outcome Measures

Name	Time	Method
Percentage of time in intended SpO2-interval	24 hours	Percentage of time with SpO2 in intended interval

Secondary Outcome Measures

Name	Time	Method
Percentage of time with SpO2 below 85 %	24 hours	Percentage of time with SpO2 below 85 %
Percentage of time with SpO2 above target	24 hours	Percentage of time with SpO2 above target
Percentage of time with SpO2 below target but not below 85 %	24 hours	Percentage of time with SpO2 below target but not below 85 %
Change in PaCO2 from baseline	24 hours	Change in PaCO2 from baseline to 24 hours
Accumulated oxygen usage	24 hours	Accumulated oxygen usage in 24 hours
Adverse and serious adverse events	24 hours	Adverse and serious adverse events, such as respiratory acidosis

Trial Locations

Locations (2)

Hvidovre University Hospital; 🇩🇰 Hvidovre, Denmark

Næstved University Hospital; 🇩🇰 Næstved, Denmark