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Completed

NCT Number: NCT02744170

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinikum Berchtesgadener Land

Schönau, Berchtesgardener Land, 83471, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

1 continuous flow oxygen supplementation

Device

This oxygen Supplementation is used in special order

Other names: Companion 1000 Chart Industries, Inc. Garfield Heights, USA

2 demand delivery liquid oxygen supplementation

Device

This oxygen Supplementation is used in special order

Other names: Caire Spirit 300 Chart Industries, Inc. Garfield Heights

3 demand delivery oxygen supplementation via concentrator

Device

This oxygen Supplementation is used in special order

Other names: one oxygen concentrator, Inogen, Goleta, CA, USA

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Schön Klinik Berchtesgadener Land

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 20, 2016
Registry last updated
Jan 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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