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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
liquid oxygen device (LOD)
portable oxygen concentrator (POC)
Sponsored by
Schön Klinik Berchtesgadener Land
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, supplemental oxygen, oxygen concentrator

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Schoen Klinik Berchtesgadener Land

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

COPD patients with delivery order 1, 2

COPD patients with delivery order 2,1

Arm Description

Patients will use two different Oxygen devices at rest (1.liquid oxygen device (Companion R), 2. portable Oxygen concentrator (Activox TM 4L))

Patients will use two different Oxygen devices at rest (1. portable Oxygen concentrator (Activox TM 4L), 2. liquid oxygen device (Companion R))

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
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.
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.

Full Information

First Posted
May 30, 2017
Last Updated
February 14, 2018
Sponsor
Schön Klinik Berchtesgadener Land
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1. Study Identification

Unique Protocol Identification Number
NCT03174210
Brief Title
Effects of Supplemental Oxygen Delivered by a Portable Oxygen Concentrator Compared to a Liquid Oxygen Device in COPD
Official Title
Effects of Supplemental Oxygen Delivered by a Portable Oxygen Concentrator Compared to a Liquid Oxygen Device in Hypoxemic COPD Patients at Rest
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
May 2, 2017 (Actual)
Primary Completion Date
September 15, 2017 (Actual)
Study Completion Date
September 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Schön Klinik Berchtesgadener Land

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, supplemental oxygen, oxygen concentrator

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
patients will be randomized into two different Groups (prospective cross-over design)
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
COPD patients with delivery order 1, 2
Arm Type
Experimental
Arm Description
Patients will use two different Oxygen devices at rest (1.liquid oxygen device (Companion R), 2. portable Oxygen concentrator (Activox TM 4L))
Arm Title
COPD patients with delivery order 2,1
Arm Type
Experimental
Arm Description
Patients will use two different Oxygen devices at rest (1. portable Oxygen concentrator (Activox TM 4L), 2. liquid oxygen device (Companion R))
Intervention Type
Device
Intervention Name(s)
liquid oxygen device (LOD)
Other Intervention Name(s)
Companion 1000 Chart Industries, Inc. Garfield Heights, USA
Intervention Description
This oxygen Supplementation is used in special order
Intervention Type
Device
Intervention Name(s)
portable oxygen concentrator (POC)
Other Intervention Name(s)
Activox™ 4L, Inovalabs Inc., Texas, USA
Intervention Description
This oxygen Supplementation is used in special order
Primary Outcome Measure Information:
Title
Difference between LOD and POC in Partial pressure of oxygen levels
Description
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)
Time Frame
after 10 minutes of each LOD step compared to 10 minutes of each POC step
Secondary Outcome Measure Information:
Title
Difference between LOD and POC in Partial pressure of carbon dioxide levels
Description
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)
Time Frame
after 10 minutes of each LOD step compared to 10 minutes of each POC step
Title
Change of partial pressure of Oxygen from one POC step to the next step
Description
Change in PO2 values from e.g. POC step 1 to POC step 2, step 2 to 3 etc.
Time Frame
after 10 minutes of one POC step compared to after 10 minutes of the next POC step
Title
Change of partial pressure of carbon dioxide from one POC step to the next step
Description
Change in PCO2 values between e.g. POC step 1 to POC step 2, step 2 to 3 etc.
Time Frame
after 10 minutes of one POC step compared to after 10 minutes of the next POC step

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus Kenn, Prof.
Organizational Affiliation
Schoen Klinik Berchtesgadener Land
Official's Role
Principal Investigator
Facility Information:
Facility Name
Schoen Klinik Berchtesgadener Land
City
Schoenau Am Koenigssee
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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