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Effects of Supplemental Oxygen Delivery Via Demand Versus Continuous Flow in Hypoxemic COPD Patients

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
1 continuous flow oxygen supplementation
2 demand delivery liquid oxygen supplementation
3 demand delivery oxygen supplementation via concentrator
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, Incremental Shuttle Walk Test, Endurance Shuttle Walk Test, oxygen therapy

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • COPD patients (GOLD stage III to IV) with hypoxemia at rest or during exercise (paO2<60mmHg)
  • Participation in an inpatient pulmonary rehabilitation program (Schön Klinik BGL)
  • Written informed consent

Exclusion Criteria:

  • General exclusion criteria for exercise tests, e.g. acute coronary syndrome, acute myo- or pericarditis, acute lung embolism, pulmonary infarction, acute uncontrolled heart insufficiency
  • Signs of acute exacerbation
  • Any orthopedic or neurological disabilities that prevent patient from walking

Sites / Locations

  • Klinikum Berchtesgadener Land

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

COPD patients with delivery order 1, 2, 3

COPD patients with delivery order 2,3, 1

COPD patients with delivery order 3, 2, 1

COPD patients with delivery order 1, 3, 2

COPD patients with delivery order 2, 1, 3

COPD patients with delivery order 3, 1, 2

Arm Description

Patients on long-term oxygen therapy will perform 3 Endurance Shuttle Walk Tests on three consecutive days with one of three different Oxygen delivery devices.

Patients on long-term oxygen therapy will perform 3 Endurance Shuttle Walk Tests on three consecutive days with one of three different Oxygen delivery devices.

Patients on long-term oxygen therapy will perform 3 Endurance Shuttle Walk Tests on three consecutive days with one of three different Oxygen delivery devices.

Patients on long-term oxygen therapy will perform 3 Endurance Shuttle Walk Tests on three consecutive days with one of three different Oxygen delivery devices.

Patients on long-term oxygen therapy will perform 3 Endurance Shuttle Walk Tests on three consecutive days with one of three different Oxygen delivery devices.

Patients on long-term oxygen therapy will perform 3 Endurance Shuttle Walk Tests on three consecutive days with one of three different Oxygen delivery devices.

Outcomes

Primary Outcome Measures

Oxygen saturation at isotime of the endurance shuttle walk test (ESWT), compared between CF (liquid oxygen) and DD (liquid oxygen)
continuous transcutaneous recording during ESWT by Sentec-Digital-Monitor

Secondary Outcome Measures

Breathing frequency
measured by Visionox
Inspiratory capacity
measured by Spiropalm
Heart rate
continuous transcutaneous recording during ESWT by Sentec-Digital-Monitor
Walking distance during ESWT
total distance walked during ESWT
dyspnea
assessed by modified Borg scale (0 to 10)
partial pressure of carbon dioxide
continuous transcutaneous recording during ESWT by Sentec-Digital-Monitor

Full Information

First Posted
March 8, 2016
Last Updated
January 18, 2019
Sponsor
Schön Klinik Berchtesgadener Land
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1. Study Identification

Unique Protocol Identification Number
NCT02744170
Brief Title
Effects of Supplemental Oxygen Delivery Via Demand Versus Continuous Flow in Hypoxemic COPD Patients
Official Title
Effects of Supplemental Oxygen Delivery Via Demand Versus Continuous Flow in Hypoxemic COPD Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
October 2018 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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).

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, Incremental Shuttle Walk Test, Endurance Shuttle Walk Test, oxygen therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
COPD patients with delivery order 1, 2, 3
Arm Type
Experimental
Arm Description
Patients on long-term oxygen therapy will perform 3 Endurance Shuttle Walk Tests on three consecutive days with one of three different Oxygen delivery devices.
Arm Title
COPD patients with delivery order 2,3, 1
Arm Type
Experimental
Arm Description
Patients on long-term oxygen therapy will perform 3 Endurance Shuttle Walk Tests on three consecutive days with one of three different Oxygen delivery devices.
Arm Title
COPD patients with delivery order 3, 2, 1
Arm Type
Experimental
Arm Description
Patients on long-term oxygen therapy will perform 3 Endurance Shuttle Walk Tests on three consecutive days with one of three different Oxygen delivery devices.
Arm Title
COPD patients with delivery order 1, 3, 2
Arm Type
Experimental
Arm Description
Patients on long-term oxygen therapy will perform 3 Endurance Shuttle Walk Tests on three consecutive days with one of three different Oxygen delivery devices.
Arm Title
COPD patients with delivery order 2, 1, 3
Arm Type
Experimental
Arm Description
Patients on long-term oxygen therapy will perform 3 Endurance Shuttle Walk Tests on three consecutive days with one of three different Oxygen delivery devices.
Arm Title
COPD patients with delivery order 3, 1, 2
Arm Type
Experimental
Arm Description
Patients on long-term oxygen therapy will perform 3 Endurance Shuttle Walk Tests on three consecutive days with one of three different Oxygen delivery devices.
Intervention Type
Device
Intervention Name(s)
1 continuous flow oxygen supplementation
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)
2 demand delivery liquid oxygen supplementation
Other Intervention Name(s)
Caire Spirit 300 Chart Industries, Inc. Garfield Heights
Intervention Description
This oxygen Supplementation is used in special order
Intervention Type
Device
Intervention Name(s)
3 demand delivery oxygen supplementation via concentrator
Other Intervention Name(s)
one oxygen concentrator, Inogen, Goleta, CA, USA
Intervention Description
This oxygen Supplementation is used in special order
Primary Outcome Measure Information:
Title
Oxygen saturation at isotime of the endurance shuttle walk test (ESWT), compared between CF (liquid oxygen) and DD (liquid oxygen)
Description
continuous transcutaneous recording during ESWT by Sentec-Digital-Monitor
Time Frame
at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT
Secondary Outcome Measure Information:
Title
Breathing frequency
Description
measured by Visionox
Time Frame
at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT
Title
Inspiratory capacity
Description
measured by Spiropalm
Time Frame
at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT
Title
Heart rate
Description
continuous transcutaneous recording during ESWT by Sentec-Digital-Monitor
Time Frame
at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT
Title
Walking distance during ESWT
Description
total distance walked during ESWT
Time Frame
at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT
Title
dyspnea
Description
assessed by modified Borg scale (0 to 10)
Time Frame
at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT
Title
partial pressure of carbon dioxide
Description
continuous transcutaneous recording during ESWT by Sentec-Digital-Monitor
Time Frame
at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: COPD patients (GOLD stage III to IV) with hypoxemia at rest or during exercise (paO2<60mmHg) Participation in an inpatient pulmonary rehabilitation program (Schön Klinik BGL) Written informed consent Exclusion Criteria: General exclusion criteria for exercise tests, e.g. acute coronary syndrome, acute myo- or pericarditis, acute lung embolism, pulmonary infarction, acute uncontrolled heart insufficiency Signs of acute exacerbation Any orthopedic or neurological disabilities that prevent patient from walking
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus Kenn, Prof. Dr.
Organizational Affiliation
Philipps University Marburg Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinikum Berchtesgadener Land
City
Schönau
State/Province
Berchtesgardener Land
ZIP/Postal Code
83471
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Supplemental Oxygen Delivery Via Demand Versus Continuous Flow in Hypoxemic COPD Patients

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