Clinical trial NCT06545851: Effects of an Automatic Oxygen Titration System in People With Hypoxemia During Exercise Training
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypoxaemia
Chronic Lung Disease
Lead sponsor: Schön Klinik Berchtesgadener Land
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

- Acute exacerbation of underlying pulmonary disease requiring cessation of exercise training.

Primary outcomes:
measure: Dyspnea
timeFrame: Day 1 to 5 and 6 to 10
Secondary outcomes:
measure: Change of oxygen saturation (SpO2) during exercise training
timeFrame: Day 1 to 5 and 6 to 10
measure: Change of transcutaneous partial CO2 pressure (TcPCO2) during exercise training
timeFrame: Day 1 to 5 and 6 to 10
measure: Change of heart rate during exercise training
timeFrame: Day 1 to 5 and 6 to 10
measure: Change of capillary partial pressure of CO2 (pCO2) during exercise training
timeFrame: Day 1 to 5 and 6 to 10
measure: Change of capillary partial pressure of O2 (pO2) during exercise training
timeFrame: Day 1 to 5 and 6 to 10
measure: Change of inspiratory capacity (IC) during exercise training
timeFrame: Day 1 to 5 and 6 to 10
measure: Time to desaturation (SpO2 <=90%) and to severe desaturation (SpO2 <=85%) during exercise training
timeFrame: Day 1 to 5 and 6 to 10
measure: Assessment of leg fatigue via BORG scale
timeFrame: Day 1 to 5 and 6 to 10
measure: Patients sensation regarding the oxygen delivery system
timeFrame: Day 5 and 10
Other outcomes:
Locations:
city: Schönau a.Königssee
country: Germany
facility: Klinikum Berchtesgadener Land, Schön Kliniken
state: Bavaria
Study officials:
affiliation: Philipps University Marburg
name: Andreas Rembert Koczulla, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kofod LM, Westerdahl E, Kristensen MT, Brocki BC, Ringbaek T, Hansen EF. Effect of Automated Oxygen Titration during Walking on Dyspnea and Endurance in Chronic Hypoxemic Patients with COPD: A Randomized Crossover Trial. J Clin Med. 2021 Oct 20;10(21):4820. doi: 10.3390/jcm10214820.
citation: 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.
citation: Vivodtzev I, L'Her E, Vottero G, Yankoff C, Tamisier R, Maltais F, Lellouche F, Pepin JL. Automated O2 titration improves exercise capacity in patients with hypercapnic chronic obstructive pulmonary disease: a randomised controlled cross-over trial. Thorax. 2019 Mar;74(3):298-301. doi: 10.1136/thoraxjnl-2018-211967. Epub 2018 Aug 30.