Effects of Supplemental Oxygen Delivery Via Demand Versus Continuous Flow in Hypoxemic COPD Patients
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      Oxygen supplementation has been proven to be effective in hypoxemic COPD patients by
      increasing oxygenation and reducing dyspnea. In clinical practice there are three common
      oxygen delivery systems used: continuous oxygen flow (CF), demand oxygen delivery with liquid
      oxygen (DDL) and demand oxgen delivery with portable oxygen concentrator (DDC). The CF
      involves considerable wastage of oxygen because oxygen is supplied during in- and exhalation.
      Demand oxygen delivery saves oxygen and results in a comparable oxygen saturation at rest in
      COPD patients. However, it is unknown, if oxygen supplementation via demand oxygen delivery
      is also sufficient during exercise in hypoxemic COPD patients. In addition, it has to be
      considered that the lower weight of demand oxygen delivery system might enable patients for
      higher physical activity level and mobility in daily life.

      The effects of These three oxygen delivery systems shall be investigated by a randomized,
      controlled cross-over Trial. Every patient has to perform an Incremental Shuttle Walk Test
      and three Endurance Shuttle Walk Tests with three different oxygen supplementation (via CF,
      DDL or DDK) in randomized order.
    

Detailed description: 
      The Principal Investigator will inform each patient about procedure, content and measurements
      of the study. It is obligatory that each patient participating in the study gives a written
      informed consent.

      Following an initial incremental shuttle walk test (ISWT) in order to determine the
      individual maximum capacity, patients will perform three endurance shuttle walk tests (ESWT)
      at 85% of the maximal pace. In randomized order, patients will complete one ESWT on CF, one
      on DDL (liquid oxygen) and one on DDC (portable oxygen concentrator). The time between the
      three ESWTs will be 24 hours in order to give enough time for regeneration. All patients will
      use the same oxygen devices (CF: Companion 1000 (CE 0050), Chart Industries, Inc. Garfield
      Heights, Ohio, USA; DD [liquid oxygen]: Caire Spirit 300 (CE 0029), Chart Industries, Inc.
      Garfield Heights, Ohio, USA), DD [portable concentrator]: Inogen G2, California, USA) and
      will carry the oxygen device in a backpack. Continuous oxygen flow in liter per minute will
      be compared to the level of demand delivery (e.g.: 2 l/min CF will be compared to DD level
      2).
    

Intervention name(s): 1 continuous flow oxygen supplementation; 2 demand delivery liquid oxygen supplementation; 3 demand delivery oxygen supplementation via concentrator
Intervention type(s): Device; Device; Device
Intervention description(s): This oxygen Supplementation is used in special order; This oxygen Supplementation is used in special order; This oxygen Supplementation is used in special order
Other intervention name(s): Companion 1000 Chart Industries, Inc. Garfield Heights, USA; Caire Spirit 300 Chart Industries, Inc. Garfield Heights; one oxygen concentrator, Inogen, Goleta, CA, USA
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: COPD; Incremental Shuttle Walk Test; Endurance Shuttle Walk Test; oxygen therapy