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

NCT06545851 | Recruiting

• 1 other identifier: O2matic exercise training
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoxaemia; Chronic Lung Disease

Outcome Measures

Primary Outcomes (1)

• Dyspnea

  Change of dyspnea sensation rated by modified Borg scale (0 to 10) taken before and after exercise training

  Day 1 to 5 and 6 to 10

Secondary Outcomes (9)

• Change of oxygen saturation (SpO2) during exercise training

  Day 1 to 5 and 6 to 10

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

  Day 1 to 5 and 6 to 10

• Change of heart rate during exercise training

  Day 1 to 5 and 6 to 10

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

  Day 1 to 5 and 6 to 10

• Change of capillary partial pressure of O2 (pO2) during exercise training

  Day 1 to 5 and 6 to 10

Study Arms (2)

Excercise Training Order A and B

EXPERIMENTAL

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.

Other: Oxygen therapy - constant oxygen flow; Other: Oxygen therapy - automatic titrating oxygen flow

Excercise Training Order B and A

EXPERIMENTAL

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).

Other: Oxygen therapy - constant oxygen flow; Other: Oxygen therapy - automatic titrating oxygen flow

Interventions

Oxygen therapy - constant oxygen flow OTHER

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

Excercise Training Order A and B; Excercise Training Order B and A

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%.

Excercise Training Order A and B; Excercise Training Order B and A

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Schön Klinik Berchtesgadener Land: lead

Study Sites (1)

Klinikum Berchtesgadener Land, Schön Kliniken

Schönau am Königssee, Bavaria, 83471, Germany

RECRUITING

Related Publications (3)

• 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.

  PMID: 34768338 BACKGROUND

• 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.

  PMID: 34656996 BACKGROUND

• 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.

  PMID: 30166425 BACKGROUND

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Andreas Rembert Koczulla, Prof. Dr.

  Philipps University Marburg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andreas Rembert Koczulla, Prof. Dr.

CONTACT

0049-8652-932730; rkoczulla@schoen-klinik.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The participant and investigator is blinded to the type of oxygen supply (constant flow or automatic titrating flow).
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: August 9, 2024
• Study Start: August 14, 2023
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: August 13, 2024

Record last verified: 2024-08

Locations

DE (1)