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

Primary Purpose

COPD, Chronic Hypoxemic Respiratory Failure

Status
Terminated
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
O2matic HOT
Oxygen concentrator
Sponsored by
Hvidovre University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD focused on measuring O2matic, Closed-loop, Pulse oximetry

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hvidovre University Hospital
  • Næstved University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Manual

O2matic

Arm Description

Fixed dose oxygen

Automated oxygen titration

Outcomes

Primary Outcome Measures

Percentage of time in intended SpO2-interval
Percentage of time with SpO2 in intended interval

Secondary Outcome Measures

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

Full Information

First Posted
October 24, 2020
Last Updated
October 4, 2023
Sponsor
Hvidovre University Hospital
Collaborators
Innovation Fund Denmark, Naestved Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04606290
Brief Title
Automated Oxygen Titration With O2matic Home Oxygen Therapy (O2matic HOT) Phase 1
Acronym
O2matic-HOT1
Official Title
Automated Oxygen Titration to Patients With COPD and Domiciliary Long-term Oxygen Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Terminated
Why Stopped
Slow recruitment
Study Start Date
October 28, 2020 (Actual)
Primary Completion Date
July 1, 2023 (Actual)
Study Completion Date
July 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hvidovre University Hospital
Collaborators
Innovation Fund Denmark, Naestved Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Chronic Hypoxemic Respiratory Failure
Keywords
O2matic, Closed-loop, Pulse oximetry

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Manual
Arm Type
Active Comparator
Arm Description
Fixed dose oxygen
Arm Title
O2matic
Arm Type
Experimental
Arm Description
Automated oxygen titration
Intervention Type
Device
Intervention Name(s)
O2matic HOT
Intervention Description
Automated oxygen titration with O2matic HOT
Intervention Type
Device
Intervention Name(s)
Oxygen concentrator
Intervention Description
Fixed dose oxygen flow from concentrator
Primary Outcome Measure Information:
Title
Percentage of time in intended SpO2-interval
Description
Percentage of time with SpO2 in intended interval
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Percentage of time with SpO2 below 85 %
Description
Percentage of time with SpO2 below 85 %
Time Frame
24 hours
Title
Percentage of time with SpO2 below target but not below 85 %
Description
Percentage of time with SpO2 below target but not below 85 %
Time Frame
24 hours
Title
Percentage of time with SpO2 above target
Description
Percentage of time with SpO2 above target
Time Frame
24 hours
Title
Change in PaCO2 from baseline
Description
Change in PaCO2 from baseline to 8 hours
Time Frame
8 hours
Title
Change in PaCO2 from baseline
Description
Change in PaCO2 from baseline to 24 hours
Time Frame
24 hours
Title
Accumulated oxygen usage
Description
Accumulated oxygen usage in 24 hours
Time Frame
24 hours
Title
Adverse and serious adverse events
Description
Adverse and serious adverse events, such as respiratory acidosis
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Ringbaek, PhD
Organizational Affiliation
Hvidovre University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Hvidovre University Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Næstved University Hospital
City
Næstved
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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