Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06545851

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinikum Berchtesgadener Land, Schön Kliniken

Schönau am Königssee, Bavaria, 83471, Germany

Location status: Recruiting

Location contact

Tessa Schneeberger, PhD

CONTACT

[email protected]

0049 - 8652 - 932730

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oxygen therapy - constant oxygen flow

Other

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

Oxygen therapy - automatic titrating oxygen flow

Other

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

Primary outcomes

  1. Dyspnea

    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

Secondary outcomes

  1. Change of oxygen saturation (SpO2) during 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).

  2. Change of transcutaneous partial CO2 pressure (TcPCO2) during exercise training

    Time frame: Day 1 to 5 and 6 to 10

    TcPCO2 measured by continuous transcutaneous recording via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland)

  3. Change of heart rate during exercise training

    Time frame: Day 1 to 5 and 6 to 10

    Heart rate measured by continuous transcutaneous recordung via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland).

  4. Change of capillary partial pressure of CO2 (pCO2) during exercise training

    Time frame: Day 1 to 5 and 6 to 10

    pCO2 measured by capillary blood gases taken before and after the exercise training

  5. Change of capillary partial pressure of O2 (pO2) during 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

  6. Change of inspiratory capacity (IC) during 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)

  7. Time to desaturation (SpO2 <=90%) and to severe desaturation (SpO2 <=85%) during 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)

  8. Assessment of leg fatigue via BORG scale

    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

  9. Patients sensation regarding the oxygen delivery system

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Andreas Rembert Koczulla, Prof. Dr.

CONTACT

[email protected]

0049-8652-932730

Sponsors and collaborators

Lead sponsor

Schön Klinik Berchtesgadener Land

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 9, 2024
Registry last updated
Aug 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Published trials that share one or more normalized conditions with this study.