Effects of an Automatic Oxygen Titration System in People With Hypoxemia During Exercise Training
- Conditions
- HypoxaemiaChronic Lung Disease
- Interventions
- Other: Oxygen therapy - constant oxygen flowOther: Oxygen therapy - automatic titrating oxygen flow
- Registration Number
- NCT06545851
- Lead Sponsor
- Schön Klinik Berchtesgadener Land
- Brief 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.
- Detailed Description
Rationale:
Hypoxaemia is common in people with chronic lung disease and can affect exercise tolerance. Oxygen therapy is then recommended.
Oxygen supplementation is usually delivered at constant oxygen flow rates. Only a few studies have investigated the short-term effects of automated oxygen delivery compared to a constant oxygen flow rate during exercise tests (e.g. 6-minute walk test, shuttle walk tests). These studies have shown that automatic oxygen delivery can lead to an acute increase in exercise capacity, including an improvement in the perception of breathlessness. The use of automated oxygen delivery during endurance exercise has not been studied. The most common reason for stopping prolonged exercise in patients with chronic lung disease is dyspnoea. Therefore, the use of automatic oxygen delivery in a pulmonary rehabilitation clinic could be beneficial in the context of personalised therapy for patients requiring oxygen if it further reduces dyspnoea, potentially enabling the patient to train their endurance even better.
Therefore, the primary aim of this study was to investigate whether the use of automatic oxygen supplementation versus constant oxygen supplementation has a different effect on the perception of dyspnoea in patients with hypoxaemia during endurance exercise.
Design:
This study is designed as a randomised, double-blind, controlled cross-over trial. Participants will first undergo a cycle-based peak work rate test to determine their individual maximal peak work rate. They then take part in two sets of five endurance training sessions. One set is performed with a constant oxygen flow prescribed for each participant, while the other uses automatic oxygen titration. The order in which these two sessions are performed is randomised.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 15
- Chronic lung disease
- Hypoxemia (pO2< 55mmHg) under room air conditions (rest or during exercise) or SpO2<88% during exercise
- established Long-term oxygen therapy or given indication for a Long-term oxygen therapy/ supplemental oxygen therapy for exercise
- Age: 18 to 80 years
- Participation in an inpatient pulmonary rehabilitation program (Schoen Klinik BGL, Germany)
- Written informed consent
- Acute exacerbation of underlying pulmonary disease requiring cessation of exercise training.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Excercise Training Order B and A Oxygen therapy - automatic titrating oxygen flow The first series of five exercise trainings employs supplemental oxygen therapy with constant flow rates (B), as prescribed.The second five series of five exercise trainings involves supplemental oxygen therapy, with automatically titrated oxygen flow rates to maintain an oxygen saturation of 90-94% (A). Excercise Training Order A and B Oxygen therapy - constant oxygen flow The first series of five exercise trainings (A) involves supplemental oxygen therapy, with automatically titrated oxygen flow rates to maintain an oxygen saturation of 90-94% (A). The second series of five exercise trainings employs supplemental oxygen therapy with constant flow rates (B), as prescribed. Excercise Training Order A and B Oxygen therapy - automatic titrating oxygen flow The first series of five exercise trainings (A) involves supplemental oxygen therapy, with automatically titrated oxygen flow rates to maintain an oxygen saturation of 90-94% (A). The second series of five exercise trainings employs supplemental oxygen therapy with constant flow rates (B), as prescribed. Excercise Training Order B and A Oxygen therapy - constant oxygen flow The first series of five exercise trainings employs supplemental oxygen therapy with constant flow rates (B), as prescribed.The second five series of five exercise trainings involves supplemental oxygen therapy, with automatically titrated oxygen flow rates to maintain an oxygen saturation of 90-94% (A).
- Primary Outcome Measures
Name Time Method Dyspnea Day 1 to 5 and 6 to 10 Change of dyspnea sensation rated by modified Borg scale (0 to 10) taken before and after exercise training
- Secondary Outcome Measures
Name Time Method Change of capillary partial pressure of CO2 (pCO2) during exercise training Day 1 to 5 and 6 to 10 pCO2 measured by capillary blood gases taken before and after the exercise training
Change of inspiratory capacity (IC) during exercise training Day 1 to 5 and 6 to 10 IC measured by Spirometry taken before and after exercise training via SpiroSense Pro® (Pari, Starnberg, Germany)
Patients sensation regarding the oxygen delivery system Day 5 and 10 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
Change of oxygen saturation (SpO2) during exercise training Day 1 to 5 and 6 to 10 SpO2 measured by continuous transcutaneous recordung via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland).
Change of transcutaneous partial CO2 pressure (TcPCO2) during exercise training Day 1 to 5 and 6 to 10 TcPCO2 measured by continuous transcutaneous recording via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland)
Change of heart rate during exercise training Day 1 to 5 and 6 to 10 Heart rate measured by continuous transcutaneous recordung via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland).
Change of capillary partial pressure of O2 (pO2) during exercise training Day 1 to 5 and 6 to 10 pO2 measured by capillary blood gases taken before and after the exercise training
Time to desaturation (SpO2 <=90%) and to severe desaturation (SpO2 <=85%) during exercise training Day 1 to 5 and 6 to 10 SpO2 measured by continuous transcutaneous recordung via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland)
Assessment of leg fatigue via BORG scale Day 1 to 5 and 6 to 10 Change of leg fatigue assessed by modified Borg scale (0 to 10) taken before and after exercise training
Trial Locations
- Locations (1)
Klinikum Berchtesgadener Land, Schön Kliniken
🇩🇪Schönau a.Königssee, Bavaria, Germany