Klinikum Berchtesgadener Land, Schön Kliniken
Schönau am Königssee, Bavaria, 83471, Germany
Location status: Recruiting
NCT Number: NCT06545851
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Schönau am Königssee, Bavaria, 83471, Germany
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
During five exercise training sessions, oxygen therapy is delivered via prescribed constant oxygen flow
During five exercise sessions, oxygen therapy is delivered via an automatically titrated oxygen flow rate to maintain an SpO2 target of 90-94%.
Time frame: 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
Time frame: Day 1 to 5 and 6 to 10
SpO2 measured by continuous transcutaneous recordung via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland).
Time frame: Day 1 to 5 and 6 to 10
TcPCO2 measured by continuous transcutaneous recording via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland)
Time frame: Day 1 to 5 and 6 to 10
Heart rate measured by continuous transcutaneous recordung via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland).
Time frame: Day 1 to 5 and 6 to 10
pCO2 measured by capillary blood gases taken before and after the exercise training
Time frame: Day 1 to 5 and 6 to 10
pO2 measured by capillary blood gases taken before and after the exercise training
Time frame: Day 1 to 5 and 6 to 10
IC measured by Spirometry taken before and after exercise training via SpiroSense Pro® (Pari, Starnberg, Germany)
Time frame: Day 1 to 5 and 6 to 10
SpO2 measured by continuous transcutaneous recordung via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland)
Time frame: 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
Time frame: 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
Contact information is provided by the study sponsor or research team.
Schön Klinik Berchtesgadener Land
Other
Automatic Oxygen Titration Versus Constant Oxygen Flow Rates During Exercise Training in Hypoxemic People With Chronic Lung Disease - a Randomized, Double-blind, Controlled Cross-over Pilot Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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