Clinical trial NCT02744170: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Incremental Shuttle Walk Test
Endurance Shuttle Walk Test
oxygen therapy
Lead sponsor: Schön Klinik Berchtesgadener Land
Sponsor class: OTHER
First posted: 2016-04-20
Enrollment: 70
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Oxygen saturation at isotime of the endurance shuttle walk test (ESWT), compared between CF (liquid oxygen) and DD (liquid oxygen)
timeFrame: at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT
Secondary outcomes:
measure: Breathing frequency
timeFrame: at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT
measure: Inspiratory capacity
timeFrame: at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT
measure: Heart rate
timeFrame: at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT
measure: Walking distance during ESWT
timeFrame: at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT
measure: dyspnea
timeFrame: at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT
measure: partial pressure of carbon dioxide
timeFrame: at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT
Other outcomes:
Locations:
city: Schönau
country: Germany
facility: Klinikum Berchtesgadener Land
state: Berchtesgardener Land
Study officials:
affiliation: Philipps University Marburg
name: Klaus Kenn, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: