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Automated Oxygen Titration in Daily Life in Patients With COPD on Home Oxygen (DaiLiHOT_1)

Primary Purpose

COPD (Chronic Obstructive Pulmonary Disease)

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Automated oxygen titration based on the oxygen saturation during activity
Sponsored by
Hvidovre University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD (Chronic Obstructive Pulmonary Disease) focused on measuring Activity, Automated oxygen titration, ADL, long term oxygen treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Verified history of COPD with FEV1/FVC < 0.70 and FEV1 < 50 %
  • Hypoxemic at rest (SpO2≤ 90 %) and fulfilment of general national criteria for LTOT

    • Partial pressure of Oxygen (PaO2) (without oxygen supplement) ≤7.3 kPa in clinically stable and optimally treated condition
    • Increase in PaO2 after oxygen supplementation (to 8.0-9.0 kPa) without decrease in arterial pH (> 0.03 kPa)
    • The oxygen is used at least 15 hours daily (optimally 24 hours daily)
    • The treatment is handled by hospital departments with lung medical expertise.
  • Able to walk at least 30 meters
  • Age >18, Cognitively able to participate in the study and willing to give informed consent

Exclusion Criteria:

  • Pulmonary or cardiac condition other than COPD limiting physical performance
  • Unstable heart condition or stenotic aortic valve disease
  • A physical condition including paralysis, lower extremity pain, or back problem limiting physical performance
  • Exacerbation in COPD treated with either antibiotics or prednisolone within the last 3 weeks

Sites / Locations

  • Copenhagen University Hospital, HvidovreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual oxygen dose

Automated oxygen dose

Arm Description

A Glittre-ADL tests will be performed and the patients will use their usual fixed dose of oxygen. Pulse rate and saturation will continuously be registered during the test. Before, and after the Glittre-ADL, the patients will be asked the rate their level of dyspnea using Borg Dyspnea Scale

A Glittre-ADL tests will be performed and the patients will use automated oxygen titration set at an SpO2-target of 90 to 94 % and an oxygen flow of 0 - 8 liters/min. Pulse rate, oxygen flow rate and saturation will continuously be registered during the test. Before, and after the Glittre-ADL, the patients will be asked the rate their level of dyspnea using Borg Dyspnea Scale

Outcomes

Primary Outcome Measures

Time used for the Glittre-ADL test
Change in time used to complete the Glittre-ADL test with automated titration compared to fixed-dose treatment

Secondary Outcome Measures

Dyspnea
Change in Dyspnea Borg (in units from 0-10) scores after performing Glittre ADL test between arms
Saturation
Change in time spent within acceptable SpO2-interval (SpO2 90 - 94 %) and time spent with moderate hypoxemia (SpO2 < 88 %) and severe hypoxemia (SpO2 < 85 %) in the two Glittre-ADL tests
Oxygen consumption
Change in average oxygen consumption between the two tests

Full Information

First Posted
September 15, 2022
Last Updated
September 22, 2023
Sponsor
Hvidovre University Hospital
Collaborators
Örebro University, Sweden, University Hospital Bispebjerg and Frederiksberg
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1. Study Identification

Unique Protocol Identification Number
NCT05553847
Brief Title
Automated Oxygen Titration in Daily Life in Patients With COPD on Home Oxygen
Acronym
DaiLiHOT_1
Official Title
Automated Oxygen Titration to Improve Activities of Daily Living in Patients With Chronic Obstructive Pulmonary Disease on Home Oxygen
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 30, 2022 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hvidovre University Hospital
Collaborators
Örebro University, Sweden, University Hospital Bispebjerg and Frederiksberg

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
The purpose of this study is to examine the effect of automated oxygen titration compared to the usual fixed dose oxygen on the patient's ability to perform activities of daily living.
Detailed Description
The patient's ability to perform ADL assessed by the Glittre-ADL test with automatic oxygen titration compared to usual fixed dose will be examined. The patients will be invited to a visit at one of the participating hospitals. The Glittre-ADL will be performed according to the protocol validated by Skumlien et al. The first test is performed for familiarization in order to avoid a learning effect in the primary tests. The patients will use the fixed-dose oxygen, established after titration to a SpO2 of 90-94 % at rest. After the familiarization test and gathering of demographics, further two Glittre-ADL tests will be performed on the same day or at another day pending on patient preference. In random order the patients will use A) automated oxygen titration set at an SpO2-target of 90 to 94 % and an oxygen flow of 0 - 8 liters/min and B) their usual fixed dose of oxygen. In both arms O2matic will monitor pulse rate and saturation continuously during the test, but only in the automated oxygen therapy arm O2matic adjusts the oxygen flow. The patients will all use a rollator as walking aid. The oxygen equipment will be placed in the rollator and the tests will be conducted without the steps (due to the use of rollator). The minimum interval between tests will be 20 minutes or until the vital values and symptoms are returned to baseline. Before, and after the Glittre-ADL, the patients will be asked the rate their level of dyspnea using Borg Dyspnea Scale.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD (Chronic Obstructive Pulmonary Disease)
Keywords
Activity, Automated oxygen titration, ADL, long term oxygen treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
multicentre double blinded randomized crossover trial
Masking
ParticipantOutcomes Assessor
Masking Description
The patient will be blinded for the oxygen supply. An independent person will prepare the oxygen setup with usual fixed dose or automated titration. The setup i covered. The assessor conducting the tests is blinded.
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual oxygen dose
Arm Type
No Intervention
Arm Description
A Glittre-ADL tests will be performed and the patients will use their usual fixed dose of oxygen. Pulse rate and saturation will continuously be registered during the test. Before, and after the Glittre-ADL, the patients will be asked the rate their level of dyspnea using Borg Dyspnea Scale
Arm Title
Automated oxygen dose
Arm Type
Experimental
Arm Description
A Glittre-ADL tests will be performed and the patients will use automated oxygen titration set at an SpO2-target of 90 to 94 % and an oxygen flow of 0 - 8 liters/min. Pulse rate, oxygen flow rate and saturation will continuously be registered during the test. Before, and after the Glittre-ADL, the patients will be asked the rate their level of dyspnea using Borg Dyspnea Scale
Intervention Type
Other
Intervention Name(s)
Automated oxygen titration based on the oxygen saturation during activity
Intervention Description
A device will be used, which automatically adjusts the oxygen flow to the dosage necessary for keeping the saturation at the recommended level (90-94%). If the saturation falls below 90%, oxygen flow will increase, and if the saturation increases above 94%, oxygen flow decreases in order to stay on target.
Primary Outcome Measure Information:
Title
Time used for the Glittre-ADL test
Description
Change in time used to complete the Glittre-ADL test with automated titration compared to fixed-dose treatment
Time Frame
Immediately after intervention (control arm test and automated oxygen titration arm) on the same day
Secondary Outcome Measure Information:
Title
Dyspnea
Description
Change in Dyspnea Borg (in units from 0-10) scores after performing Glittre ADL test between arms
Time Frame
Immediately after the intervention
Title
Saturation
Description
Change in time spent within acceptable SpO2-interval (SpO2 90 - 94 %) and time spent with moderate hypoxemia (SpO2 < 88 %) and severe hypoxemia (SpO2 < 85 %) in the two Glittre-ADL tests
Time Frame
Immediately after the intervention
Title
Oxygen consumption
Description
Change in average oxygen consumption between the two tests
Time Frame
Immediately after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Verified history of COPD with FEV1/FVC < 0.70 and FEV1 < 50 % Hypoxemic at rest (SpO2≤ 90 %) and fulfilment of general national criteria for LTOT Partial pressure of Oxygen (PaO2) (without oxygen supplement) ≤7.3 kPa in clinically stable and optimally treated condition Increase in PaO2 after oxygen supplementation (to 8.0-9.0 kPa) without decrease in arterial pH (> 0.03 kPa) The oxygen is used at least 15 hours daily (optimally 24 hours daily) The treatment is handled by hospital departments with lung medical expertise. Able to walk at least 30 meters Age >18, Cognitively able to participate in the study and willing to give informed consent Exclusion Criteria: Pulmonary or cardiac condition other than COPD limiting physical performance Unstable heart condition or stenotic aortic valve disease A physical condition including paralysis, lower extremity pain, or back problem limiting physical performance Exacerbation in COPD treated with either antibiotics or prednisolone within the last 3 weeks
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Linette M Kofod, PT
Phone
+45 38621619
Email
linette.marie.kofod@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Elisabeth Westerdahl, PhD
Email
elisabeth.westerdahl@regionorebrolan.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linette M Kofod
Organizational Affiliation
Hvidovre University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Copenhagen University Hospital, Hvidovre
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linette M Kofod, PT
Phone
+4538621619

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data could be available on reasonable request, but needs to follow the rules set by the danish Data Protection Agency.

Learn more about this trial

Automated Oxygen Titration in Daily Life in Patients With COPD on Home Oxygen

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