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

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ClinicalTrials.gov Identifier: NCT02744170
Recruitment Status : Completed
First Posted : April 20, 2016
Last Update Posted : January 21, 2019
Sponsor:
Information provided by (Responsible Party):
Klaus Kenn, Schön Klinik Berchtesgadener Land

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.


Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Device: 1 continuous flow oxygen supplementation Device: 2 demand delivery liquid oxygen supplementation Device: 3 demand delivery oxygen supplementation via concentrator Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Supplemental Oxygen Delivery Via Demand Versus Continuous Flow in Hypoxemic COPD Patients
Actual Study Start Date : April 2016
Actual Primary Completion Date : October 2018
Actual Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Experimental: COPD patients with delivery order 1, 2, 3
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.
Device: 1 continuous flow oxygen supplementation
This oxygen Supplementation is used in special order
Other Name: Companion 1000 Chart Industries, Inc. Garfield Heights, USA

Device: 2 demand delivery liquid oxygen supplementation
This oxygen Supplementation is used in special order
Other Name: Caire Spirit 300 Chart Industries, Inc. Garfield Heights

Device: 3 demand delivery oxygen supplementation via concentrator
This oxygen Supplementation is used in special order
Other Name: one oxygen concentrator, Inogen, Goleta, CA, USA

Experimental: COPD patients with delivery order 2,3, 1
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.
Device: 1 continuous flow oxygen supplementation
This oxygen Supplementation is used in special order
Other Name: Companion 1000 Chart Industries, Inc. Garfield Heights, USA

Device: 2 demand delivery liquid oxygen supplementation
This oxygen Supplementation is used in special order
Other Name: Caire Spirit 300 Chart Industries, Inc. Garfield Heights

Device: 3 demand delivery oxygen supplementation via concentrator
This oxygen Supplementation is used in special order
Other Name: one oxygen concentrator, Inogen, Goleta, CA, USA

Experimental: COPD patients with delivery order 3, 2, 1
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.
Device: 1 continuous flow oxygen supplementation
This oxygen Supplementation is used in special order
Other Name: Companion 1000 Chart Industries, Inc. Garfield Heights, USA

Device: 2 demand delivery liquid oxygen supplementation
This oxygen Supplementation is used in special order
Other Name: Caire Spirit 300 Chart Industries, Inc. Garfield Heights

Device: 3 demand delivery oxygen supplementation via concentrator
This oxygen Supplementation is used in special order
Other Name: one oxygen concentrator, Inogen, Goleta, CA, USA

Experimental: COPD patients with delivery order 1, 3, 2
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.
Device: 1 continuous flow oxygen supplementation
This oxygen Supplementation is used in special order
Other Name: Companion 1000 Chart Industries, Inc. Garfield Heights, USA

Device: 2 demand delivery liquid oxygen supplementation
This oxygen Supplementation is used in special order
Other Name: Caire Spirit 300 Chart Industries, Inc. Garfield Heights

Device: 3 demand delivery oxygen supplementation via concentrator
This oxygen Supplementation is used in special order
Other Name: one oxygen concentrator, Inogen, Goleta, CA, USA

Experimental: COPD patients with delivery order 2, 1, 3
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.
Device: 1 continuous flow oxygen supplementation
This oxygen Supplementation is used in special order
Other Name: Companion 1000 Chart Industries, Inc. Garfield Heights, USA

Device: 2 demand delivery liquid oxygen supplementation
This oxygen Supplementation is used in special order
Other Name: Caire Spirit 300 Chart Industries, Inc. Garfield Heights

Device: 3 demand delivery oxygen supplementation via concentrator
This oxygen Supplementation is used in special order
Other Name: one oxygen concentrator, Inogen, Goleta, CA, USA

Experimental: COPD patients with delivery order 3, 1, 2
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.
Device: 1 continuous flow oxygen supplementation
This oxygen Supplementation is used in special order
Other Name: Companion 1000 Chart Industries, Inc. Garfield Heights, USA

Device: 2 demand delivery liquid oxygen supplementation
This oxygen Supplementation is used in special order
Other Name: Caire Spirit 300 Chart Industries, Inc. Garfield Heights

Device: 3 demand delivery oxygen supplementation via concentrator
This oxygen Supplementation is used in special order
Other Name: one oxygen concentrator, Inogen, Goleta, CA, USA




Primary Outcome Measures :
  1. Oxygen saturation at isotime of the endurance shuttle walk test (ESWT), compared between CF (liquid oxygen) and DD (liquid oxygen) [ Time Frame: at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT ]
    continuous transcutaneous recording during ESWT by Sentec-Digital-Monitor


Secondary Outcome Measures :
  1. Breathing frequency [ Time Frame: at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT ]
    measured by Visionox

  2. Inspiratory capacity [ Time Frame: at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT ]
    measured by Spiropalm

  3. Heart rate [ Time Frame: at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT ]
    continuous transcutaneous recording during ESWT by Sentec-Digital-Monitor

  4. Walking distance during ESWT [ Time Frame: at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT ]
    total distance walked during ESWT

  5. dyspnea [ Time Frame: at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT ]
    assessed by modified Borg scale (0 to 10)

  6. partial pressure of carbon dioxide [ Time Frame: at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT ]
    continuous transcutaneous recording during ESWT by Sentec-Digital-Monitor



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02744170


Locations
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Germany
Klinikum Berchtesgadener Land
Schönau, Berchtesgardener Land, Germany, 83471
Sponsors and Collaborators
Schön Klinik Berchtesgadener Land
Investigators
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Principal Investigator: Klaus Kenn, Prof. Dr. Philipps University Marburg Medical Center

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Responsible Party: Klaus Kenn, Prof. Dr. Klaus Kenn, Schön Klinik Berchtesgadener Land
ClinicalTrials.gov Identifier: NCT02744170     History of Changes
Other Study ID Numbers: O2-Demand-Study
First Posted: April 20, 2016    Key Record Dates
Last Update Posted: January 21, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Klaus Kenn, Schön Klinik Berchtesgadener Land:
COPD
Incremental Shuttle Walk Test
Endurance Shuttle Walk Test
oxygen therapy
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases