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NCT Number: NCT03803384

Effects of an Auto-Regulating Oxygen System Compared to Constant-Flow Oxygen During Walking in Hypoxemic COPD Patients

Oxygen therapy is a cornerstone in treating patients with severe chronic obstructive pulmonary disease. Usually, oxygen supplementation is delivered using constant-flow rates. Varying oxygenation levels may occur throughout patients´ changing activity. There is some evidence available that an auto-regulating oxygen flow system (FreeO2), which adjusts the oxygen flow automatically to prevent desoxygenation could be beneficial in comparison to a constant oxygen dose of 2 liter/min during walking. However, these possible benefits are unknown if the FreeO2 is compared to a constant oxygen dose according to the individual prescription. Therefore, the primary aim of this study is to investigate the effects of auto-regulated oxygen flow rates compared to constant oxygen flow rates as prescribed according to international guidelines on walking capacity in patients with COPD.

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Key information

Conditions

COPD Behavior Chronic Disease Disease Attributes Hypoxia Lung Diseases Lung Diseases, Obstructive Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Schoen Klinik Berchtesgadener Land

Schönau am Königssee, Bavaria, 83471, Germany

About this study

Rationale:

Hypoxemia is frequently observed in COPD and thus can negatively impact exercise tolerance. Supplemental oxygen or long-term oxygen therapy is recommended to ensure that the patient is still able to manage his daily life. Usually, oxygen supplementation is delivered using constant flow rates during day- and nighttime or as needed. However, studies have shown, that auto-regulated oxygen flow systems (FreeO2) may enhance the patients endurance, lower the time in severe hypoxemia and increase the time spent within the SpO2 target range.

Aim of this study is to investigate the effects off an auto-regulated oxygen flow system in hypoxemic COPD patients on the patient´s endurance, the oxygen saturation, the pCO2 blood level as well as on heart rate and breathing frequency compared to the effects off the prescribed constant flow (according to the British Thoracic Society Guidelines for Home Oxygen Use in Adults) during an endurance shuttle walk test (ESWT). Additionally, patients experience, e.g. comfort and Preference of the Oxygen-delivery System will be documented.

Design:

This study is a randomized, controlled cross-over trial. Following an initial incremental shuttle walk test (ISWT) in order to determine the participants individual maximal walking capacity, the participant will perform 2 endurance shuttle walk tests (ESWT) at 85% of the maximal walking rate. In randomized order, the participants will perform one ESWT with constant flow as prescribed and one ESWT with the auto-regulated oxygen flow system.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • GOLD III/ IV
  • Hypoxemia (PaO2<55 mmHg) under roomair conditions (rest or during exercise) or SpO2 <88% during exercise
  • established Long-term oxygen therapy or given indication for a Long-term oxygen therapy
  • Age: 40 to 80 years
  • Participation in an inpatient pulmonary rehabilitation program (Schoen Klinik BGL, Germany)
  • Written informed consent

Exclusion criteria

  • Acute Exacerbation of COPD
  • Clinical signs of any acute cardiac comorbidity
  • Not able to walk

Treatment and study plan

Oxygen therapy

Other

Oxygen supply during ESWT, once with the prescribed constant oxygen flow and once using an auto-regulated oxygen flow system setting the SpO2 target at 92%.

Primary outcomes

  1. Endurance time

    Time frame: Day 1 and Day 2

    Change of Walking Duration during the ESWT

Secondary outcomes

  1. Change of oxygen saturation during the endurance shuttle walk test.

    Time frame: Day 1 and Day 2

    SpO2 measured by continuous transcutaneous recordung via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland).

  2. Time to desaturation (SpO2 <=90%) and to severe desaturation (SpO2 <=85%)

    Time frame: Day 1 and Day 2

    SpO2 measured by continuous transcutaneous recordung via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland) and FreeO2 Device.

  3. Change of capillary partial pressure of CO2 (pCO2) during endurance shuttle walk test

    Time frame: Day 1 and Day 2

    pCO2 measured by capillary blood gases taken before and after the ESWT.

  4. Change of capillary partial pressure of O2 (pO2) during endurance shuttle walk test

    Time frame: Day 1 and Day 2

    pO2 measured by capillary blood gases taken before and after the ESWT.

  5. Change of partial pressure of CO2 (pCO2) during endurance shuttle walk test

    Time frame: Day 1 and Day 2

    pCO2 measured by continuous transcutaneous recording via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland)

  6. Change of heart rate during endurance shuttle walk test

    Time frame: Day 1 and Day 2

    Heart rate measured by continuous transcutaneous recordung via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland).

  7. Change of breathing frequency during endurance shuttle walk test

    Time frame: Day 1 and Day 2

    Breathing frequency during the ESWT measured by ApneaLink Air™ (ResMed, ...)

  8. Patients Preference due to oxygen delivery system

    Time frame: Day 1 and Day 2

    Patients will be asked to rate their experienced comfort after each ESWT

Sponsors and collaborators

Lead sponsor

Schön Klinik Berchtesgadener Land

Other

Registry information

Official study title

Effects of an Auto-Regulating Oxygen System Compared to Constant-Flow Oxygen During Walking in Hypoxemic COPD Patients - a Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 14, 2019
Registry last updated
Nov 27, 2019

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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