Trial document




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  DRKS00021524

Trial Description

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Title

Comparison of the work-of-breathing and the activity of the muscles of breathing through Surface-electromyography during non-invasive lung Ventilation

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The goal of this study is to examine a method to improve patient ventilation in invasive- and non-invasive ventilation. By measuring respiratory muscle activity during non-invasive ventilation via small electrodes (comparable to those used for ECG) as well as measuring the esophageal pressure using a stomach tube, we can provide important findings about the work of breathing.

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Brief Summary in Scientific Language

The Goal of this study is to examine a new, non-invasive tool developed by the Company DRÄGER, which uses surface-electromyography (sEMG) to measure the activity of respiratory muscles at two different sites (parasternal and diaphragmatic). This tool allows measurement of muscle activity without the negative effects of an invasive measurement via an esophageal probe. This new method also potentially allows for mechanical support proportional to the patients individual needs and the improvement of patient- ventilator asynchrony.
Furthermore it provides diagnostic benefits: measuring the diaphragmatic activity could possibly be a early-warning system for prolonged weaning.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00021524
  •   2020/04/28
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  •   no
  •   Approved
  •   137/2017, Ethik-Kommission der Universität Witten/Herdecke
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Secondary IDs

  •   U1111-1250-8927 
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Health Condition or Problem studied

  •   J44 -  Other chronic obstructive pulmonary disease
  •   J84 -  Other interstitial pulmonary diseases
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Interventions/Observational Groups

  •   Measuring of sEMG (Surface-electromyography) and pressure (gastral and esophageal) in the fully awake an spontaneous breathing state and in the sedated and assisted spontaneous breathing state with different pressure-levels of assistence.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   I
  •   N/A
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Primary Outcome

The Primary Goal is to identify changes in the work of brathing and the sEMG-signal (Surface-electromyography) during invasive ventilation.
For aquiring these information we continously monitor the sEMG of the diaphragm and the intercostal muscles via small electrodes glued to the Skin as well as the esophageal pressure via a esophageal probe.

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Secondary Outcome

The influence of the work of breathing on additional data provided by the Ventilator (mouth pressure, gas-flow, FiO2, FeCO2).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Planned
  •   2020/05/01
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Indication for elective bronchoscopy:
- COPD GOLD I-IV (chronic obstructive pulmonary disease)
- Interstitial lung disease (confirmed or suspected)
- suspected lung cancer
- Age > 18 years

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Exclusion Criteria

indication for acute bronchoscopy (i.e. hemoptysis, tumor-recanalisation)
- neuromuscular diseases
- drug abuse
- anamnestic esphageal Stenosis or varices
- risk for bleeding in the laborchemistry
- pregnancy

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Addresses

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    • Drägerwerk AG & Co.KGaA
    • Moislinger Allee 53-55
    • 23558  Lübeck
    • Germany
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    • Klinikum Konstanz II. Medizin
    • Mr.  Dr. med.  Stephan  Walterspacher 
    • Mainaustr. 35
    • 78464  Konstanz
    • Germany
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    • Klinikum Konstanz II. Medizin
    • Mr.  Dr. med.  Stephan  Walterspacher 
    • Mainaustr. 35
    • 78464  Konstanz
    • Germany
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Sources of Monetary or Material Support

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    • Drägerwerk AG & Co.KGaA
    • Moislinger Allee 53-55
    • 23558  Lübeck
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.