Comparison of mobile oxygenconcentrators: fixed Minute volume System vs. constant Bolus System

Not Applicable

Recruiting

• Conditions: J44.8; Other specified chronic obstructive pulmonary disease

• Registration Number: DRKS00017000
• Lead Sponsor: Kliniken der Stadt Köln

Brief Summary

Both portable oxygen-conserving devices met the success criteria in 96% of patients in the 6MWT when they were titrated to the correct level. The constant-bolus device required a significantly lower operating level to achieve the success criteria, hereby reducing energy consumption. Individual titration of the respective device is recommended, which can be facilitated by the novel titration algorithm described here.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-01
• Results First Posted: 2023-11-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Patients with COPD GOLD IV (FEV1<30%; FEV1/IVC < LLN) and/or respiratory insufficiency
Recommended oxygensupplementation during exercise <3l/min
Written consent
Patients >18 years

Exclusion Criteria

Patients < 18 years
Breathing frequency at rest >25
acute exacerbation of COPD defined as acute worsening of respiratory Symptoms which require a Change of therapy [Christian Viniol, Claus F. Vogelmeie r- European Respiratory Review 2018 27: 170103]
no written consent
absolute contraindication for arterial BGA

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Final operating Level of the OCD device Zen O Lite and final operating Level of the OCD device Inogen One.

Secondary Outcome Measures

Name	Time	Method
- Comparison of 6 MWT with each OCD device after first 6MWT (Walking distance, BORG Dyspnoea, Desaturation >4% to <90%, Breathing frequency before and after Intervention)<br>- Comparison of 6 MWT without any Oxygen Supplementation and each device on final operating level (Walking distance, BORG Dyspnoea, Desaturation >4% to <90%, Breathing frequency before and after Intervention)<br>- Comparison of 6 MWT without any Oxygen Supplementation and each device on after first 6MWT (Walking distance, BORG Dyspnoea, Desaturation >4% to <90%, Breathing frequency before and after Intervention)<br>- highest setting necessary of OCD <br>- Preference of patients<br>- pneumologic Standard diagnostics such as spirometry, bodyplethysmography and diffusion<br>