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

Automated Oxygen Titration to Patients with COPD and Domiciliary Long-term Oxygen Treatment

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.

Study Overview

• Status: Terminated
• Conditions: COPD; Chronic Hypoxemic Respiratory Failure
• Intervention / Treatment: Device: Oxygen concentrator; Device: 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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Hvidovre, Denmark, 2650
    • Hvidovre University Hospital
  • Næstved, Denmark
    • Næstved University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Manual; Fixed dose oxygen	Device: Oxygen concentrator; Fixed dose oxygen flow from concentrator
Experimental: O2matic; Automated oxygen titration	Device: O2matic HOT; Automated oxygen titration with O2matic HOT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of time in intended SpO2-interval	Percentage of time with SpO2 in intended interval	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of time with SpO2 below 85 %	Percentage of time with SpO2 below 85 %	24 hours
Percentage of time with SpO2 below target but not below 85 %	Percentage of time with SpO2 below target but not below 85 %	24 hours
Percentage of time with SpO2 above target	Percentage of time with SpO2 above target	24 hours
Change in PaCO2 from baseline	Change in PaCO2 from baseline to 8 hours	8 hours
Change in PaCO2 from baseline	Change in PaCO2 from baseline to 24 hours	24 hours
Accumulated oxygen usage	Accumulated oxygen usage in 24 hours	24 hours
Adverse and serious adverse events	Adverse and serious adverse events, such as respiratory acidosis	24 hours

Collaborators and Investigators

• Sponsor: Hvidovre University Hospital
• Collaborators: Innovation Fund Denmark; Naestved Hospital
• Investigators: Study Chair: Thomas Ringbaek, PhD, Hvidovre University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2020
• Primary Completion (Actual): July 1, 2023
• Study Completion (Actual): July 1, 2023

Study Registration Dates

• First Submitted: October 24, 2020
• First Submitted That Met QC Criteria: October 24, 2020
• First Posted (Actual): October 28, 2020

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 10, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: O2matic; Closed-loop; Pulse oximetry
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: O2matic-HOT1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No