Trial document




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  DRKS00017000

Trial Description

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Title

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

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Trial Acronym

[---]*

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URL of the Trial

http://[---]*

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Brief Summary in Lay Language

Long term Oxygen therapy describes the application of Oxygen for at least 15h/day. Mobile Oxygen therapy describes Oxygen therapy under the use of a mobile Oxygen delivery System. In General there are three different application Systems, mobile liquid Oxygen, mobile Oxygen concentrators and mobile Oxygen tanks. In order to reduce Oxygen consumption with the aim to prolong the application time manufacturers produced special Oxygen conserving devices (OCD).
These usually applicate Oxygen only during Inspiration, therefore saving up to 2/3 of Oxygen application.
Some devices deliver a constant Bolus of Oxygen per breath, others deliver a constant amount of Oxygen per Minute.
The aim of this study is to compare both These Systems in their daily life Usability. The participants will be tested for necessity of Long term Oxygen therapy before inclusion and will afterwards, after getting used to the Oxygen System, fulfill 6-Minute Walk Tests with each device separately. Afterwards we will allocate the data from Experiments and the participants will be asked for preferences.

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Brief Summary in Scientific Language

The participants will be included in the study, after being checked for inclusion criteria and giving written consent. The measurements are part of usual clinical Routine practice for patients with respiratory insufficiency. In a randomized controlled Trial hypoxemic COPD patients will be equipped with a fixed pulse volume and a fixed Minute volume Oxygen concentrator.
Patients will be evaluated for necessity of Oxygen therapy through arterial blood gas Analysis. Afterwards the participants will perform a 6-minute walk Tests with constant Monitoring of SpO2, heart rate and respiratory rate before and after.
After completion of the walk test participants will be seated and rest for approximately 20 minutes, while meanwhile getting used to one of the Oxygen concentrators. Afterwards they will complete another 6 Minute walk test with the new concentrator with the same Monitoring.
After another 20 minutes rest with the second concentrator participants will perform a third 6 Minute walk test with the second device

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Organizational Data

  •   DRKS00017000
  •   2019/04/01
  •   [---]*
  •   yes
  •   Approved
  •   21/2019, Ethik-Kommission der Universität Witten/Herdecke
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   J44.8 -  Other specified chronic obstructive pulmonary disease
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Interventions/Observational Groups

  •   Examination of patients with COPD (chronic obstructive pulmonary disease) Gold IV in a stable state of their disease. An arterial BGA (Arterial blood gas test) will be performed the necessity of Oxygen therapy. Afterwards a first 6-minute walk test (6MWT) will be performed to assess the Performance without Oxygen Supplementation. After a pause patients will be randomized to one of the Oxygen concentrators with a second 6MWT. If Titration of Oxygen support is necessary another 6MWT with the higher or lower Level of Oxygen support will be performed. Afterwards the participant will be seated and trained in the use of the second Oxygen concentrator. After an adequate time of rest of at least 20 minutes the Patient will now perform a 6MWT with the second device, also with the possibility of Titration. A maximum of 5 6MWT´s per day will be performed. Before finishing the study patients will be asked for their personal preference.
  •   Examination of patients with COPD Gold IV in a stable state of their disease. An arterial BGA will be performed the necessity of Oxygen therapy. Afterwards a first 6-minute walk test (6MWT) will be performed to assess the Performance without Oxygen Supplementation. After a pause patients will be randomized to one of the Oxygen concentrators with a second 6MWT. If Titration of Oxygen support is necessary another 6MWT with the higher or lower Level of Oxygen support will be performed. Afterwards the participant will be seated and trained in the use of the second Oxygen concentrator. After an adequate time of rest of at least 20 minutes the Patient will now perform a 6MWT with the second device, also with the possibility of Titration. A maximum of 5 6MWT´s per day will be performed. Before finishing the study patients will be asked for their personal preference.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Treatment
  •   Crossover
  •   N/A
  •   N/A
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Primary Outcome

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

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Secondary Outcome

- 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)
- 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)
- 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)
- highest setting necessary of OCD
- Preference of patients
- pneumologic Standard diagnostics such as spirometry, bodyplethysmography and diffusion

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2019/07/17
  •   25
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   99   Years
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Additional 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

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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

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Addresses

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    • Kliniken der Stadt Köln
    • Mr.  Prof. Dr.  Wolfram  Windisch 
    • Ostmerheimer Str.200
    • 51109  Köln
    • Germany
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    • Kliniken der Stadt Köln
    • Ms.  Dr. med  Friederike  Magnet 
    • Ostmerheimer Str. 200
    • 51109  Köln
    • Germany
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    • Kliniken der Stadt - Lungenklinik
    • Mr.  Prof.  Wolfram  Windisch 
    • Ostmerheimer Straße 200
    • 51109  Köln
    • Germany
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Sources of Monetary or Material Support

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    • GCE Ltd
    • 100 Empress Park Penny Lane Haydock ST HELENS WA11 9DB.
    • WA11 9DB  St Helens
    • United Kingdom
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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