Trial document




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  DRKS00011650

Trial Description

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Title

Regional lung function testing by electrical impedance tomography (EIT) in invasive mechanical ventilation in Asthma and COPD

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Trial Acronym

[---]*

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URL of the Trial

http://

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Brief Summary in Lay Language

The number of patients treated for severe exacerbation of obstructive lung diseases such as Asthma or COPD is currently rising. Especially patients suffering from COPD in advanced stages of the disease often require respiratory support by mechanical ventilation. In case of invasive mechanical ventilation the settings of the ventilator are frequently challenging because of the constricted airways with severe airflow obstruction and hyperinflation. With electric impedance tomography (EIT) the regional ventilation of the lung in Asthma and COPD can be made visible and the expiratory time constant of the respiratory system can be measured on regional levels. The primary goal of the study is a better understanding of the obstruction of the airways and of the regional ventilation of the lungs with different ventilator pressure settings in correlation with blood gas analysis. This is a diagnostic study without intervention.

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Brief Summary in Scientific Language

In acute exacerbation of Asthma bronchiale or COPD requiring invasive mechanical ventilation the regional ventilation of the lung is measured by electrical impedance tomography (EIT). So far it is not possible to assess the true ventilation of the lung on a regional level. With EIT the regional lung function can be made visible and the ventilation can be measured with different ventilator pressure settings. These measurements are correlated with the results of blood gas analysis and the clinical presentation of the patient. Especially a correlation with the regional exspiratory time constant is generated.

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Organizational Data

  •   DRKS00011650
  •   2017/01/31
  •   [---]*
  •   yes
  •   Approved
  •   149/2016, Ethik-Kommission der Universität Witten/Herdecke
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Secondary IDs

  •   U1111-1192-0396 
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Health Condition or Problem studied

  •   J44.9 -  Chronic obstructive pulmonary disease, unspecified
  •   J46 -  Status asthmaticus
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Interventions/Observational Groups

  •   Observational study of patients with acute exacerbation of asthma or COPD requiring invasive mechanical ventilation. All patients receive an EIT belt around the thorax to determine regional lung function testing, including stretch and the expiratory time constant.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   No
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Primary Outcome

Measurement of the changes in impedance and consequently of the regional ventilation and the exspiratory time constant (absolute in sec.) by EIT in invasive mechanical ventilation
in acute exacerbation

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Secondary Outcome

•Correlation of blood gas analysis with the regional Ventilation in EIT
•Correlation of blood gas analysis with the expiratory time constant in EIT
•Correlation of volume waveforms of the ventilator with EIT Data

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2017/02/06
  •   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

• acute exacerbation of asthma or COPD, requiring invasive mechanical ventilation
• Age ≥ 18 years
• placement of EIT belt technically possible

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Exclusion Criteria

• pacemaker or implanted defibrillator
• Combination with other devices measuring impedance
• larger wounds in the area of potential placement of the EIT belt

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Lungenklinik Köln-MerheimARDS und ECMO-Zentrum
    • Mr.  Prof. Dr.  Christrian  Karagiannidis 
    • Ostmerheimer Str. 200
    • 51109  Köln
    • Germany
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    • Lungenklinik Köln-MerheimARDS und ECMO-Zentrum
    • Mr.  Prof. Dr.  Christrian  Karagiannidis 
    • Ostmerheimer Str. 200
    • 51109  Köln
    • Germany
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    • Lungenklinik Köln-MerheimARDS und ECMO-Zentrum
    • Mr.  Prof. Dr.  Christrian  Karagiannidis 
    • Ostmerheimer Str. 200
    • 51109  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Lungenklinik Köln-Merheim
    • Mr.  Prof. Dr.  Christrian  Karagiannidis 
    • Ostmerheimer Str. 200
    • 51109  Köln
    • Germany
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    • Swisstom AG
    • Mr.  Dr.  Stephan  Böhm 
    • Schulstrasse 1
    • 7302  Landquart
    • Switzerland
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Status

  •   Recruiting ongoing
  •   [---]*
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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.