Effects of an Auto-Regulating Oxygen System Compared to Constant-Flow Oxygen During Walking in Hypoxemic COPD Patients
Condition: COPD
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Oxygen therapy
Intervention type(s): Other
Intervention description(s): 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%.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: hypoxemia, exercise, oxygen, automatic oxygen-titration