Effects of an Auto-Regulating Oxygen System Compared to Constant-Flow Oxygen During Walking in Hypoxemic COPD Patients

NCT03803384 | Completed

• 1 other identifier: COPD FreeO2-Study
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

Oxygen therapy is a cornerstone in treating patients with severe chronic obstructive pulmonary disease. Usually, oxygen supplementation is delivered using constant-flow rates. Varying oxygenation levels may occur throughout patients´ changing activity. There is some evidence available that an auto-regulating oxygen flow system (FreeO2), which adjusts the oxygen flow automatically to prevent desoxygenation could be beneficial in comparison to a constant oxygen dose of 2 liter/min during walking. However, these possible benefits are unknown if the FreeO2 is compared to a constant oxygen dose according to the individual prescription. Therefore, the primary aim of this study is to investigate the effects of auto-regulated oxygen flow rates compared to constant oxygen flow rates as prescribed according to international guidelines on walking capacity in patients with COPD.

Conditions

COPD

Keywords

hypoxemia, exercise, oxygen, automatic oxygen-titration

Outcome Measures

Primary Outcomes (1)

• Endurance time

  Change of Walking Duration during the ESWT

  Day 1 and Day 2

Secondary Outcomes (8)

• Change of oxygen saturation during the endurance shuttle walk test.

  Day 1 and Day 2

• Time to desaturation (SpO2 <=90%) and to severe desaturation (SpO2 <=85%)

  Day 1 and Day 2

• Change of capillary partial pressure of CO2 (pCO2) during endurance shuttle walk test

  Day 1 and Day 2

• Change of capillary partial pressure of O2 (pO2) during endurance shuttle walk test

  Day 1 and Day 2

• Change of partial pressure of CO2 (pCO2) during endurance shuttle walk test

  Day 1 and Day 2

Study Arms (2)

ESWT Order A and B

EXPERIMENTAL

First Endurance Shuttle walk test (A) with supplemental Oxygen therapy via auto-regulated oxygen flow rates (FreeO2) to maintain a oxygen saturation of 92% and second Endurance Shuttle walk (B) test with supplemental Oxygen therapy via constant oxygen flow rates

Other: Oxygen therapy

ESWT Order B and A

EXPERIMENTAL

First Endurance Shuttle walk test (B) with supplemental Oxygen therapy via constant oxygen flow rates and second Endurance Shuttle walk (A) test with supplemental Oxygen therapy via auto-regulated oxygen flow rates (FreeO2) to maintain a oxygen saturation of 92%

Other: Oxygen therapy

Interventions

Oxygen therapy OTHER

Oxygen supply during ESWT, once with the prescribed constant oxygen flow and once using an auto-regulated oxygen flow system setting the SpO2 target at 92%.

ESWT Order A and B; ESWT Order B and A

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• GOLD III/ IV
• Hypoxemia (PaO2\<55 mmHg) under roomair conditions (rest or during exercise) or SpO2 \<88% during exercise
• established Long-term oxygen therapy or given indication for a Long-term oxygen therapy
• Age: 40 to 80 years
• Participation in an inpatient pulmonary rehabilitation program (Schoen Klinik BGL, Germany)
• Written informed consent

You may not qualify if:

• Acute Exacerbation of COPD
• Clinical signs of any acute cardiac comorbidity
• Not able to walk

Sponsors & Collaborators

• Schön Klinik Berchtesgadener Land: lead

Study Sites (1)

Schoen Klinik Berchtesgadener Land

Schönau am Königssee, Bavaria, 83471, Germany

Location

Related Publications (2)

• Lellouche F, L'Her E, Bouchard PA, Brouillard C, Maltais F. Automatic Oxygen Titration During Walking in Subjects With COPD: A Randomized Crossover Controlled Study. Respir Care. 2016 Nov;61(11):1456-1464. doi: 10.4187/respcare.04406. Epub 2016 Oct 18.

  PMID: 27794080 BACKGROUND

• Schneeberger T, Jarosch I, Leitl D, Gloeckl R, Hitzl W, Dennis CJ, Geyer T, Criee CP, Koczulla AR, Kenn K. Automatic oxygen titration versus constant oxygen flow rates during walking in COPD: a randomised controlled, double-blind, crossover trial. Thorax. 2023 Apr;78(4):326-334. doi: 10.1136/thoraxjnl-2020-216509. Epub 2021 Oct 16.

  PMID: 34656996 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Hypoxia; Motor Activity

Interventions

Oxygen

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• Klaus Kenn, Prof. Dr.

  Philipps University Marburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The Partcipant and Investigator is blinded to the type of oxygen supply (constant flow or auto-regulated flow).
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr. med. Klaus Kenn

Study Record Dates

• First Submitted: January 7, 2019
• First Posted: January 14, 2019
• Study Start: January 7, 2019
• Primary Completion: November 26, 2019
• Study Completion: November 26, 2019
• Last Updated: November 27, 2019

Record last verified: 2019-11

Locations

DE (1)