Effects of Supplemental Oxygen Delivered by a Portable Oxygen Concentrator Compared to a Liquid Oxygen Device in COPD

Effects of Supplemental Oxygen Delivered by a Portable Oxygen Concentrator Compared to a Liquid Oxygen Device in Hypoxemic COPD Patients at Rest

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®).

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Device: liquid oxygen device (LOD); Device: portable oxygen concentrator (POC)

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Schoenau Am Koenigssee, Germany
    • Schoen Klinik Berchtesgadener Land

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• COPD patients with hypoxemia at rest (paO2 < 55 or 60 mmHg, according to the recent supplemental oxygen guidelines [Hadringe, M., et al., British Thoracic Society guidelines for home oxygen use in adults. Thorax, 2015. 70 Suppl 1: p. i1-43.]
• Participation in an inpatient pulmonary rehabilitation program (Schön Klinik BGL)
• Written informed consent

Exclusion Criteria:

• The Need of more than 4 Liter/min Oxygen at rest to achieve PaO2 > 55 or 60mmHg
• Signs of acute exacerbation
• General exclusion criteria for exercise tests, e.g. acute coronary syndrome, acute myo- or pericarditis, acute lung embolism, pulmonary infarction, acute uncontrolled heart insufficiency

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: COPD patients with delivery order 1, 2; Patients will use two different Oxygen devices at rest (1.liquid oxygen device (Companion R), 2. portable Oxygen concentrator (Activox TM 4L))	Device: liquid oxygen device (LOD); This oxygen Supplementation is used in special order; Other Names: Companion 1000 Chart Industries, Inc. Garfield Heights, USA; Device: portable oxygen concentrator (POC); This oxygen Supplementation is used in special order; Other Names: Activox™ 4L, Inovalabs Inc., Texas, USA
Experimental: COPD patients with delivery order 2,1; Patients will use two different Oxygen devices at rest (1. portable Oxygen concentrator (Activox TM 4L), 2. liquid oxygen device (Companion R))	Device: liquid oxygen device (LOD); This oxygen Supplementation is used in special order; Other Names: Companion 1000 Chart Industries, Inc. Garfield Heights, USA; Device: portable oxygen concentrator (POC); This oxygen Supplementation is used in special order; Other Names: Activox™ 4L, Inovalabs Inc., Texas, USA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference between LOD and POC in Partial pressure of oxygen levels	PO2 values between LOD and POC at comparable Levels of oxygen supply (1liter/minute LOD will be compared to Level 1 of POC until 4liters/Minute LOD to Level 4 of POC)	after 10 minutes of each LOD step compared to 10 minutes of each POC step

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference between LOD and POC in Partial pressure of carbon dioxide levels	PCO2 values between LOD and POC at comparable Levels of oxygen supply (1liter/minute LOD will be compared to Level 1 of POC until 4liters/Minute LOD to Level 4 of POC)	after 10 minutes of each LOD step compared to 10 minutes of each POC step
Change of partial pressure of Oxygen from one POC step to the next step	Change in PO2 values from e.g. POC step 1 to POC step 2, step 2 to 3 etc.	after 10 minutes of one POC step compared to after 10 minutes of the next POC step
Change of partial pressure of carbon dioxide from one POC step to the next step	Change in PCO2 values between e.g. POC step 1 to POC step 2, step 2 to 3 etc.	after 10 minutes of one POC step compared to after 10 minutes of the next POC step

Collaborators and Investigators

• Sponsor: Schön Klinik Berchtesgadener Land

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2017
• Primary Completion (Actual): September 15, 2017
• Study Completion (Actual): September 15, 2017

Study Registration Dates

• First Submitted: May 30, 2017
• First Submitted That Met QC Criteria: May 30, 2017
• First Posted (Actual): June 2, 2017

Study Record Updates

• Last Update Posted (Actual): February 15, 2018
• Last Update Submitted That Met QC Criteria: February 14, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: COPD; supplemental oxygen; oxygen concentrator
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: ActivoxTitration

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No