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

COPD Clinical Trial

— O2matic-HOT1  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04606290
• Other study ID #: O2matic-HOT1
• Status: Terminated
• Phase: N/A
• Start date: October 28, 2020
• Est. completion date: July 1, 2023

Study information

• Verified date: October 2023
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: July 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Hypoxemic Respiratory Failure
• COPD
• Respiratory Insufficiency

Intervention

Device:
• O2matic HOT
Automated oxygen titration with O2matic HOT
• Oxygen concentrator
Fixed dose oxygen flow from concentrator

Locations

Country	Name	City	State
Denmark	Hvidovre University Hospital	Hvidovre
Denmark	Næstved University Hospital	Næstved

Sponsors (3)

Lead Sponsor	Collaborator
Hvidovre University Hospital	Innovation Fund Denmark, Naestved Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of time in intended SpO2-interval	Percentage of time with SpO2 in intended interval	24 hours
Secondary	Percentage of time with SpO2 below 85 %	Percentage of time with SpO2 below 85 %	24 hours
Secondary	Percentage of time with SpO2 below target but not below 85 %	Percentage of time with SpO2 below target but not below 85 %	24 hours
Secondary	Percentage of time with SpO2 above target	Percentage of time with SpO2 above target	24 hours
Secondary	Change in PaCO2 from baseline	Change in PaCO2 from baseline to 8 hours	8 hours
Secondary	Change in PaCO2 from baseline	Change in PaCO2 from baseline to 24 hours	24 hours
Secondary	Accumulated oxygen usage	Accumulated oxygen usage in 24 hours	24 hours
Secondary	Adverse and serious adverse events	Adverse and serious adverse events, such as respiratory acidosis	24 hours