Trial document
DRKS00021524
Trial Description
Title
Comparison of the work-of-breathing and the activity of the muscles of breathing through Surface-electromyography during non-invasive lung Ventilation
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.
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.
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
Secondary IDs
- U1111-1250-8927
Health Condition or Problem studied
- J44 - Other chronic obstructive pulmonary disease
- J84 - Other interstitial pulmonary diseases
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.
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
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.
Secondary Outcome
The influence of the work of breathing on additional data provided by the Ventilator (mouth pressure, gas-flow, FiO2, FeCO2).
Countries of Recruitment
- Germany
Locations of Recruitment
- Medical Center
Recruitment
- Planned
- 2020/05/01
- 50
- Monocenter trial
- National
Inclusion Criteria
- Both, male and female
- 18 Years
- no maximum age
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
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
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-sponsorstart of 1:1-Block address contact primary-sponsor- 074518820
- 074518822080
- info at draeger.com
- http://www.draeger.com
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-contactstart of 1:1-Block address contact scientific-contact- 075318011451
- 075318011453
- stephan.walterspacher at glkn.de
- http://www.lungenzentrum-bodensee.de
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Klinikum Konstanz II. Medizin
- Mr. Dr. med. Stephan Walterspacher
- Mainaustr. 35
- 78464 Konstanz
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- 075318011451
- 075318011453
- stephan.walterspacher at glkn.de
- http://www.lungenzentrum-bodensee.de
end of 1:1-Block address contact public-contact
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 materialSupportstart of 1:1-Block address contact materialSupport- 074518820
- 074518822080
- info at draeger.com
- http://www.draeger.com
end of 1:1-Block address contact materialSupport
Status
- Recruiting planned
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Trial Publications, Results and other Documents
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