Effects of an Automatic Oxygen Titration System in People With Hypoxemia During Exercise Training

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-14

Study Completion Date

2024-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hypoxaemia Chronic Lung Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

The participant and investigator is blinded to the type of oxygen supply (constant flow or automatic titrating flow).

Study Groups

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Excercise Training Order A and B

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.

Group Type EXPERIMENTAL

Oxygen therapy - constant oxygen flow

Intervention Type OTHER

During five exercise training sessions, oxygen therapy is delivered via prescribed constant oxygen flow

Oxygen therapy - automatic titrating oxygen flow

Intervention Type OTHER

During five exercise sessions, oxygen therapy is delivered via an automatically titrated oxygen flow rate to maintain an SpO2 target of 90-94%.

Excercise Training Order B and A

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).

Group Type EXPERIMENTAL

Oxygen therapy - constant oxygen flow

Intervention Type OTHER

During five exercise training sessions, oxygen therapy is delivered via prescribed constant oxygen flow

Oxygen therapy - automatic titrating oxygen flow

Intervention Type OTHER

During five exercise sessions, oxygen therapy is delivered via an automatically titrated oxygen flow rate to maintain an SpO2 target of 90-94%.

Interventions

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Oxygen therapy - constant oxygen flow

During five exercise training sessions, oxygen therapy is delivered via prescribed constant oxygen flow

Intervention Type OTHER

Oxygen therapy - automatic titrating 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%.

Intervention Type OTHER

Eligibility Criteria

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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