Effects of an Automatic Oxygen Titration System in People With Hypoxemia During Exercise Training
NCT Number: NCT06545851
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hypoxaemia|Chronic Lung Disease
Interventions: OTHER: Oxygen therapy - constant oxygen flow|OTHER: Oxygen therapy - automatic titrating oxygen flow
Sponsor: Schön Klinik Berchtesgadener Land
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2023-08-14
Completion Date: 2024-11-30
Locations: Klinikum Berchtesgadener Land, Schön Kliniken, Schönau a.Königssee, Bavaria, 83471, Germany

Summary:
Long-term oxygen therapy is a fundamental treatment modality for patients with chronic hypoxaemic lung disease. Typically, oxygen is administered at a constant flow rate. However, due to fluctuating activity levels, patients' oxygenation status can vary, potentially leading to oxygen desaturation and increased dyspnoea.

Emerging evidence suggests that automatic oxygen titration - a method of adjusting oxygen flow in response to current oxygen saturation - may have acute advantages over constant oxygen flow.

The primary objective of this study is to investigate the effect of automatic oxygen titration compared to prescribed constant oxygen flow rates on patients' perceived dyspnoea during exercise endurance training.

Primary Outcome Measures: Dyspnea, Change of dyspnea sensation rated by modified Borg scale (0 to 10) taken before and after exercise training, Day 1 to 5 and 6 to 10
Secondary Outcome Measures: Change of oxygen saturation (SpO2) during exercise training, SpO2 measured by continuous transcutaneous recordung via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland)., Day 1 to 5 and 6 to 10|Change of transcutaneous partial CO2 pressure (TcPCO2) during exercise training, TcPCO2 measured by continuous transcutaneous recording via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland), Day 1 to 5 and 6 to 10|Change of heart rate during exercise training, Heart rate measured by continuous transcutaneous recordung via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland)., Day 1 to 5 and 6 to 10|Change of capillary partial pressure of CO2 (pCO2) during exercise training, pCO2 measured by capillary blood gases taken before and after the exercise training, Day 1 to 5 and 6 to 10|Change of capillary partial pressure of O2 (pO2) during exercise training, pO2 measured by capillary blood gases taken before and after the exercise training, Day 1 to 5 and 6 to 10|Change of inspiratory capacity (IC) during exercise training, IC measured by Spirometry taken before and after exercise training via SpiroSense Pro® (Pari, Starnberg, Germany), Day 1 to 5 and 6 to 10|Time to desaturation (SpO2 <=90%) and to severe desaturation (SpO2 <=85%) during exercise training, SpO2 measured by continuous transcutaneous recordung via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland), Day 1 to 5 and 6 to 10|Assessment of leg fatigue via BORG scale, Change of leg fatigue assessed by modified Borg scale (0 to 10) taken before and after exercise training, Day 1 to 5 and 6 to 10|Patients sensation regarding the oxygen delivery system, Patients will be asked to rate their experienced comfort after Session 1 and Session 2 via a 5-point Likert Skale: strongly agree, agree, neutral, disagree, strongly disagree, Day 5 and 10