Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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%. |
| Measure | Description | Time Frame |
|---|---|---|
| Endurance time | Change of Walking Duration during the ESWT | Day 1 and Day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Time to desaturation (SpO2 <=90%) and to severe desaturation (SpO2 <=85%) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Klaus Kenn, Prof. Dr. | Philipps University Marburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schoen Klinik Berchtesgadener Land | Schönau am Königssee | Bavaria | 83471 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27794080 | Background | 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. | |
| 34656996 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D000860 | Hypoxia |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
Not provided
Not provided
| ID | Term |
|---|---|
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
Not provided
Not provided
Not provided
Not provided
Not provided
The Partcipant and Investigator is blinded to the type of oxygen supply (constant flow or auto-regulated flow).
SpO2 measured by continuous transcutaneous recordung via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland) and FreeO2 Device. |
| Day 1 and Day 2 |
| 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 |
| 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 |
| 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 |
| 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 |
| Change of breathing frequency during endurance shuttle walk test | Breathing frequency during the ESWT measured by ApneaLink Air™ (ResMed, ...) | Day 1 and Day 2 |
| Patients Preference due to oxygen delivery system | Patients will be asked to rate their experienced comfort after each ESWT | Day 1 and Day 2 |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D001519 | Behavior |