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

NCT05553847 | Completed DMC

• 1 other identifier: Fys1977
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Keywords

Activity; Automated oxygen titration; ADL; long term oxygen treatment

Outcome Measures

Primary Outcomes (1)

• 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

  Immediately after intervention (control arm test and automated oxygen titration arm) on the same day

Secondary Outcomes (3)

• Dyspnea

  Immediately after the intervention

• Saturation

  Immediately after the intervention

• Oxygen consumption

  Immediately after the intervention

Study Arms (2)

Usual oxygen dose

NO INTERVENTION

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

Automated oxygen dose

EXPERIMENTAL

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

Other: Automated oxygen titration based on the oxygen saturation during activity

Interventions

Automated oxygen titration based on the oxygen saturation during activity OTHER

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.

Automated oxygen dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hvidovre University Hospital: lead
• Örebro University, Sweden: collaborator
• University Hospital Bispebjerg and Frederiksberg: collaborator

Study Sites (1)

Copenhagen University Hospital, Hvidovre

Hvidovre, 2650, Denmark

Location

Related Publications (1)

• Kofod LM, Hansen EF, Brocki BC, Kristensen MT, Roberts NB, Westerdahl E. Optimised oxygenation improves functional capacity during daily activities in patients with COPD on long-term oxygen therapy: a randomised crossover trial. Thorax. 2025 Oct 15;80(11):803-809. doi: 10.1136/thorax-2024-221883.

  PMID: 40473413 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Linette M Kofod

  Hvidovre University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist, Primary investigator

Model Details: multicentre double blinded randomized crossover trial

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: September 23, 2022
• Study Start: October 30, 2022
• Primary Completion: November 14, 2023
• Study Completion: November 14, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)