Trial document




drksid header

  DRKS00015780

Trial Description

start of 1:1-Block title

Title

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

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

The goal of this study is to examine a method to improve patient ventilation through mechanical lung ventilators. Measuring the activity of the muscles of Respiration during mechanical assisted Ventilation via small electrodes (comparable to those used for ECG) as well as measuring the pressure using a stomach tube can provide important findings about controlling a lung ventilator.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

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 inspiratory activity of the muscles of Respiration at two different sites (parasternal and diaphragmatic). This tool allows to measure the muscle activity without negative effects of a invasive measurement via a esophageal probe. This new method potentially allows for mechanical Support proportional to the patients individual needs.
Furthermore it provides diagnostic benefits: measuring the diaphragmatic activity could possibly be a early-warning System for prolonged weaning.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00015780
  •   2018/10/23
  •   [---]*
  •   no
  •   Approved
  •   137/2017, Ethik-Kommission der Universität Witten/Herdecke
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   U1111-1222-6208 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   J44 -  Other chronic obstructive pulmonary disease
  •   J84 -  Other interstitial pulmonary diseases
end of 1:N-Block indications
start of 1:N-Block interventions

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. Active and passive movements of the patients are also documented.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   I
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

The Primary Goal is to identify changes in the work of brathing and the sEMG-signal (Surface-electromyography) during invasive ventilatkion.
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.
During assisted Ventilation the data provided by the lung Ventilator (mouth pressure, gas-flow, FiO2, FeCO2) were also documented.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Another Point of interest were the changes in the sEMG-signal provoked by movements (cough, active and passive movements of the extremities).

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2018/10/23
  •   50
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

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

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

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

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Drägerwerk AG & Co.KGaA
    • Moislinger Allee 53-55
    • 23558  Lübeck
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Klinikum Konstanz II. Medizin
    • Mr.  Dr. med.  Stephan  Walterspacher 
    • Mainaustr. 35
    • 78464  Konstanz
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Klinikum Konstanz II. Medizin
    • Mr.  Max  Kustermann 
    • Mainaustr. 35
    • 78464  Konstanz
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Drägerwerk AG & Co.KGaA
    • Moislinger Allee 53-55
    • 23558  Lübeck
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.