Effects of an Automatic Oxygen Titration System in People With Hypoxemia During Exercise Training
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSchön Klinik Berchtesgadener Land
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Design model
Crossover
Treatments tested in this trial
Oxygen therapy - constant oxygen flow
Other interventionDuring five exercise training sessions, oxygen therapy is delivered via prescribed constant oxygen flow
Oxygen therapy - automatic titrating oxygen flow
Other interventionDuring five exercise sessions, oxygen therapy is delivered via an automatically titrated oxygen flow rate to maintain an SpO2 target of 90-94%.
Treatment groups
15 Participants
are divided into 2 treatment groupsGroup A: Excercise Training Order A and BExperimental treatment 2 interventions
Group B: Excercise Training Order B and AExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Dyspnea
Change of dyspnea sensation rated by modified Borg scale (0 to 10) taken before and after exercise training
Time frame
Day 1 to 5 and 6 to 10Secondary outcomes
1
Change of oxygen saturation (SpO2) during exercise training
SpO2 measured by continuous transcutaneous recordung via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland).
Time frame
Day 1 to 5 and 6 to 102
Change of transcutaneous partial CO2 pressure (TcPCO2) during exercise training
TcPCO2 measured by continuous transcutaneous recording via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland)
Time frame
Day 1 to 5 and 6 to 103
Change of heart rate during exercise training
Heart rate measured by continuous transcutaneous recordung via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland).
Time frame
Day 1 to 5 and 6 to 104
Change of capillary partial pressure of CO2 (pCO2) during exercise training
pCO2 measured by capillary blood gases taken before and after the exercise training
Time frame
Day 1 to 5 and 6 to 10Sponsors and contacts
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Source ClinicalTrials.gov