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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02744170
• Other study ID #: O2-Demand-Study
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: October 2018

Study information

• Verified date: January 2019
• Source: Klinikum Berchtesgadener Land der Schön-Kliniken
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• 1 continuous flow oxygen supplementation
This oxygen Supplementation is used in special order
• 2 demand delivery liquid oxygen supplementation
This oxygen Supplementation is used in special order
• 3 demand delivery oxygen supplementation via concentrator
This oxygen Supplementation is used in special order

Locations

Country	Name	City	State
Germany	Klinikum Berchtesgadener Land	Schönau	Berchtesgardener Land

Sponsors (1)

Lead Sponsor	Collaborator
Klinikum Berchtesgadener Land der Schön-Kliniken

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT
Secondary	Breathing frequency	measured by Visionox	at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT
Secondary	Inspiratory capacity	measured by Spiropalm	at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT
Secondary	Heart rate	continuous transcutaneous recording during ESWT by Sentec-Digital-Monitor	at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT
Secondary	Walking distance during ESWT	total distance walked during ESWT	at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT
Secondary	dyspnea	assessed by modified Borg scale (0 to 10)	at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT
Secondary	partial pressure of carbon dioxide	continuous transcutaneous recording during ESWT by Sentec-Digital-Monitor	at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT