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Automated Oxygen Titration During Walking in Patients With COPD

NCT04123730 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2021-06-30

No results posted yet for this study

Summary

Purpose: to evaluate the immediate effect of automated oxygen titration compared to usual fixed-dose oxygen treatment during exercise in patients with COPD on long-term oxygen treatment.

Methods: The study will be conducted as a double blinded randomized crossover trial with two arms. 40 ambulatory patients with COPD and home oxygen treatment will be included from AHH Hospital's catchment area. The patients will conduct two Endurance Shuttle Walk Tests (ESWT) in a crossover design using an O2matic device to deliver a variable oxygen dosage set at an SpO2-target of 90-94% and an O2-flow of 0 - 15 liters/min and using the patients´ usual fixed-dose oxygen delivery, in a randomized order. In both arms O2matic will monitor pulse rate and SpO2 continuously during the test, but only in the automated oxygen titration arm will O2matic adjust oxygen flow. The patient and the physiotherapist supervising the tests will be blinded to the oxygen dose. Primary outcome is the changes in perceived dyspnea intensity using Borg CR10 scale between walking with automated titration compared to fixed-dose treatment. Secondary outcomes are differences in walking time, the average oxygen consumption between automated oxygen titration and fixed-dose treatment and difference in time spent within acceptable SpO2-interval.

Conditions

Interventions

OTHER

Fixed-dose compared to variable oxygen flow supplementation during walking

At day 1 the patients will perform Walk A and Walk B in a random order: Walk A: The patients will perform a Endurance Shuttle Walk Tests (ESWT) with the fixed-dose (FOT). O2matic will monitor pulse rate and saturation continuously during the test. Walk B: The patients will perform a Endurance Shuttle Walk Tests (ESWT) with a variable oxygen flow (AOT) depending on the saturation. O2matic will monitor pulse rate and saturation continuously during the test, and adjust oxygen flow depending on the saturation. At day 2 the patients will perform two 6 minutes walking (MWT) test in random order: Walk C: A 6 MWT with FOT Walk D; A 6 MWT with AOT

Sponsors & Collaborators

  • Region Örebro County

    collaborator OTHER

  • Aalborg University Hospital

    collaborator OTHER

  • Danmarks Lungeforening

    collaborator OTHER

  • Hvidovre University Hospital

    lead OTHER

Principal Investigators

  • Linette Marie Kofod, PT · Hvidovre University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-28
Primary Completion
2020-12-01
Completion
2020-12-01

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04123730 on ClinicalTrials.gov