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

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03803384
• Other study ID #: COPD FreeO2-Study
• Status: Completed
• Phase: N/A
• Start date: January 7, 2019
• Est. completion date: November 26, 2019

Study information

• Verified date: November 2019
• Source: Schön Klinik Berchtesgadener Land
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: November 26, 2019
• Est. primary completion date: November 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• COPD

Intervention

Other:
• Oxygen therapy
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%.

Locations

Country	Name	City	State
Germany	Schoen Klinik Berchtesgadener Land	Schönau Am Königssee	Bayern

Sponsors (1)

Lead Sponsor	Collaborator
Schön Klinik Berchtesgadener Land

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. Epub 2016 Oct 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endurance time	Change of Walking Duration during the ESWT	Day 1 and Day 2
Secondary	Change of oxygen saturation during the endurance shuttle walk test.	SpO2 measured by continuous transcutaneous recordung via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland).	Day 1 and Day 2
Secondary	Time to desaturation (SpO2 <=90%) and to severe desaturation (SpO2 <=85%)	SpO2 measured by continuous transcutaneous recordung via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland) and FreeO2 Device.	Day 1 and Day 2
Secondary	Change of capillary partial pressure of CO2 (pCO2) during endurance shuttle walk test	pCO2 measured by capillary blood gases taken before and after the ESWT.	Day 1 and Day 2
Secondary	Change of capillary partial pressure of O2 (pO2) during endurance shuttle walk test	pO2 measured by capillary blood gases taken before and after the ESWT.	Day 1 and Day 2
Secondary	Change of partial pressure of CO2 (pCO2) during endurance shuttle walk test	pCO2 measured by continuous transcutaneous recording via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland)	Day 1 and Day 2
Secondary	Change of heart rate during endurance shuttle walk test	Heart rate measured by continuous transcutaneous recordung via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland).	Day 1 and Day 2
Secondary	Change of breathing frequency during endurance shuttle walk test	Breathing frequency during the ESWT measured by ApneaLink Air™ (ResMed, ...)	Day 1 and Day 2
Secondary	Patients Preference due to oxygen delivery system	Patients will be asked to rate their experienced comfort after each ESWT	Day 1 and Day 2