Clinical trial NCT03803384: Effects of an Auto-Regulating Oxygen System Compared to Constant-Flow Oxygen During Walking in Hypoxemic COPD Patients
Official title: Effects of an Auto-Regulating Oxygen System Compared to Constant-Flow Oxygen During Walking in Hypoxemic COPD Patients - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: hypoxemia, exercise, oxygen, automatic oxygen-titration
Lead sponsor: Schön Klinik Berchtesgadener Land
Sponsor class: OTHER
First posted: 2019-01-14
Enrollment: 55
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Detailed description: Rationale:

Hypoxemia is frequently observed in COPD and thus can negatively impact exercise tolerance. Supplemental oxygen or long-term oxygen therapy is recommended to ensure that the patient is still able to manage his daily life. Usually, oxygen supplementation is delivered using constant flow rates during day- and nighttime or as needed. However, studies have shown, that auto-regulated oxygen flow systems (FreeO2) may enhance the patients endurance, lower the time in severe hypoxemia and increase the time spent within the SpO2 target range.

Aim of this study is to investigate the effects off an auto-regulated oxygen flow system in hypoxemic COPD patients on the patient´s endurance, the oxygen saturation, the pCO2 blood level as well as on heart rate and breathing frequency compared to the effects off the prescribed constant flow (according to the British Thoracic Society Guidelines for Home Oxygen Use in Adults) during an endurance shuttle walk test (ESWT). Additionally, patients experience, e.g. comfort and Preference of the Oxygen-delivery System will be documented.

Design:

This study is a randomized, controlled cross-over trial. Following an initial incremental shuttle walk test (ISWT) in order to determine the participants individual maximal walking capacity, the participant will perform 2 endurance shuttle walk tests (ESWT) at 85% of the maximal walking rate. In randomized order, the participants will perform one ESWT with constant flow as prescribed and one ESWT with the auto-regulated oxygen flow system.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Endurance time
timeFrame: Day 1 and Day 2
Secondary outcomes:
measure: Change of oxygen saturation during the endurance shuttle walk test.
timeFrame: Day 1 and Day 2
measure: Time to desaturation (SpO2 <=90%) and to severe desaturation (SpO2 <=85%)
timeFrame: Day 1 and Day 2
measure: Change of capillary partial pressure of CO2 (pCO2) during endurance shuttle walk test
timeFrame: Day 1 and Day 2
measure: Change of capillary partial pressure of O2 (pO2) during endurance shuttle walk test
timeFrame: Day 1 and Day 2
measure: Change of partial pressure of CO2 (pCO2) during endurance shuttle walk test
timeFrame: Day 1 and Day 2
measure: Change of heart rate during endurance shuttle walk test
timeFrame: Day 1 and Day 2
measure: Change of breathing frequency during endurance shuttle walk test
timeFrame: Day 1 and Day 2
measure: Patients Preference due to oxygen delivery system
timeFrame: Day 1 and Day 2
Other outcomes:
Locations:
city: Schönau Am Königssee
country: Germany
facility: Schoen Klinik Berchtesgadener Land
state: Bayern
Study officials:
affiliation: Philipps University Marburg
name: Klaus Kenn, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.