Effects of Supplemental Oxygen Delivered by a Portable Oxygen Concentrator Compared to a Liquid Oxygen Device in COPD
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      The aim of this study is to investigate the effects of supplemental oxygen on blood
      oxygenation at rest in Patients with severe to very severe COPD comparing the portable oxygen
      concentrator (Activox™ 4L) to a liquid continuous oxygen device (Companion®).
    

Detailed description: 
      It has been proven that supplemental oxygen increases oxygen saturation and reduces dyspnea
      in hypoxemic COPD Patients. There are different oxygen delivery systems available, some of
      them operating with liquid oxygen and others by concentrating the ambient air
      (concentrators). An advantage of the concentrator system is, that there is no refill
      required, but only a power plug and plug socket, enabling the patient for higher mobility and
      to be more autonomous. There are only few publications about whether portable oxygen
      concentrators have a comparable efficiency on oxygen saturation to liquid oxygen devices with
      continuous flow (LOD) or not. Until now there are no official recommendations about how to
      convert the oxygen flow rate for LOD (liter per minute) into the corresponding level of the
      POC.

      Therefore, we investigate the comparability of the portable oxygen concentrator Activox™ 4L
      (POC) to a liquid oxygen device (Companion®) in 30 hypoxemic COPD patients at rest.

      As a baseline assessment, the patients will receive a bodyplethysmography, blood gas analysis
      without using supplemental oxygen and an evaluation of the diffusion capacity of the lung for
      CO.

      The study will be conducted on 2 consecutive days. 15 patients will be randomized into two
      different groups: First group will start with POC and will continue the following day with
      LOD; The second group will start with LOD and continue with POC (cross-over design). All
      patients will use the same oxygen devices during the study assessments (LOD: Companion 1000
      (CE 0050), Chart Industries Inc., Garfiel Heights, OH, USA; POC: Activox™ 4L, Inovalabs Inc.,
      Texas, USA). On both days of the study, patients will be connected to one of the two systems
      via nasal cannula for a total time period of 40 minutes, while the patient remains in a
      sitting position without talking. The oxygen flow rate starts at 1liter/min (LOD) or Level 1
      (POC) and will be increased every 10 minutes to the next higher level until the maximum of
      4l/min (LOD) or level 4 (POC) is reached. Blood gases were taken and breathing frequency will
      be recorded at the end of each Oxygen Level.
    

Intervention name(s): liquid oxygen device (LOD); portable oxygen concentrator (POC)
Intervention type(s): Device; Device
Intervention description(s): 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; Activox™ 4L, Inovalabs Inc., Texas, USA
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: patients will be randomized into two different Groups (prospective cross-over design)
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: COPD; supplemental oxygen; oxygen concentrator