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Completed

NCT Number: NCT02998515

Effects of Different Oxygen Devices in Hypoxemic COPD Patients

Taken recent literature together, there is a sufficient number of trials investigating the effect of different oxygen devices. However, studies comparing oxygen delivery via portable oxygen concentrator (POC) and liquid oxygen device (LOD) with appropriate exercise testing and sufficient power are missing.

Given that walking is the most important activity of daily life to preserve the maintenance and to participate in social life, we aim to investigate the effects of two different oxygen delivery systems during walking in hypoxemic COPD patients (POC vs. LOD).

The endurance shuttle walk test (ESWT) is well validated for measuring endurance walking capacity in COPD patients with good repeatability. The advantage of this test over the 6MWT is that the ESWT is performed at 85% of the individual maximum which is close to the intensity of typical daily activities. Due to the fact that the ESWT enables us to determine the maximum duration of exercise and to compare values at isotime (at the point of time when the shortest of the 3 ESWTs ends), we use the ESWT as exercise test in our trial.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Severe

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Schön Klinik Berchtesgadener Land

Schönau am Königssee, 83471, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • COPD patients (GOLD stage III to IV) with hypoxemia at rest or during exercise (paO2<60mmHg)
  • Participation in an inpatient pulmonary rehabilitation program (Schön Klinik BGL)
  • Written informed consent

Exclusion criteria

  • General exclusion criteria for exercise tests, e.g. acute coronary syndrome, acute myo- or pericarditis, acute lung embolism, pulmonary infarction, acute uncontrolled heart insufficiency
  • Signs of acute exacerbation
  • Any orthopedic or neurological disabilities that prevent patient from walking

Treatment and study plan

Companion (Liquid oxygen device)

Device

Other names: Device: Companion

Activox (concentrator)

Device

Other names: Device: Activox

Primary outcomes

  1. Change in oxygen Saturation during endurance shuttle walk test (ESWT) compared between POC (concentrator) and LOD (liquid oxygen)

    Time frame: Change from baseline to the individual end of ESWT (until exhaustion, max. 20 minutes)

    ESWT is designed to assess the Maximum Walking Duration that can be sustained at 85% of individual Maximum capacity. Therefore, outcome Parameter will also be assessed at the individual end of the ESWT.

Secondary outcomes

  1. Change in Breathing frequency

    Time frame: Change from baseline to the individual end of ESWT (until exhaustion, max. 20 minutes)

    ESWT is designed to assess the Maximum Walking Duration that can be sustained at 85% of individual Maximum capacity. Therefore, outcome Parameter will also be assessed at the individual end of the ESWT.

  2. Change in Inspiratory capacity

    Time frame: Change from baseline to the individual end of ESWT(until exhaustion, max. 20 minutes)

    ESWT is designed to assess the Maximum Walking Duration that can be sustained at 85% of individual Maximum capacity. Therefore, outcome Parameter will also be assessed at the individual end of the ESWT.

    Inspiratory capacity will be measured by a mobile spirometry (SpiroPalm mask).

  3. Endurance shuttle walk distance

    Time frame: at the end of ESWT (until exhaustion, max. 20 minutes)

    ESWT is designed to assess the Maximum Walking Duration that can be sustained at 85% of individual Maximum capacity.

  4. Change in perceived Dyspnea

    Time frame: Change from baseline to the individual end of ESWT (until exhaustion, max. 20 minutes)

    ESWT is designed to assess the Maximum Walking Duration that can be sustained at 85% of individual Maximum capacity. Therefore, outcome Parameter will also be assessed at the individual end of the ESWT. Dyspnea will be rated by the Patient on a 10-point Borg scale.

  5. Change in partial pressure of carbon dioxide

    Time frame: Change from baseline to the individual end of ESWT (until exhaustion, max. 20 minutes)

    ESWT is designed to assess the Maximum Walking Duration that can be sustained at 85% of individual Maximum capacity. Therefore, outcome Parameter will also be assessed at the individual end of the ESWT.

Sponsors and collaborators

Lead sponsor

Schön Klinik Berchtesgadener Land

Other

Collaborators

  • ResMed

Registry information

Official study title

Effects of Supplemental Oxygen Delivery Via Portable Oxygen Concentrator (Activox™4L) vs. Liquid Oxygen Device in Hypoxemic COPD Patients - a Non-inferiority Study

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 20, 2016
Registry last updated
Aug 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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