Trial document




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  DRKS00003276

Trial Description

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Title

new diagnosis and scoring system for patients with cystic fibrosis: feasibility study based on electrical impedance tomography (EIT) compared to computer tomography (CT)

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Electrical impedance tomography (EIT) is a non-invasive, radiation-free imaging technique for continuously monitoring air distribution in the lung. In previous studies, EIT was proved to be reliable and able to examine respiration in a dynamic way.
Up to now, there is no EIT study on cystic fibrosis patients. Therefore, we planed this feasibility study in order to answer three main questions: is the information obtained with EIT comparable to that obtained with CT in respect of cystic fibrosis assessment? Can additional information about lung function of the patients be obtained through the dynamic components of EIT analysis? Would this finding lead to a more accurate and robust description of patients’ condition?
The patients with cystic fibrosis will be recruited, who have a scheduled or emergent CT examination. Within 24 hours, the EIT measurement will be performed. During the routine lung function examination, an extra elastic belt with ECG electrodes will be placed around the patients' thorax. The changes in regional air content and regional blood flow modify the electrical impedance of lung tissue and these changes are measured through the electrodes.
The patients will not feel anything uncomfortable during the measurement and there will be no risk with EIT examination. On the contrary, additional dynamic information about the condition of the lung can be obtained.

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Brief Summary in Scientific Language

In order to recognize an exacerbation in patients with cystic fibrosis precisely, imaging techniques such as conventional radiography and computed tomography (CT) are often employed. CT is considered as gold standard for assessment of tidal volume distribution in injured lungs. Unfortunately, due to radiation, CT is inadequate for long term monitoring of disease progression.
Electrical impedance tomography (EIT) is a noninvasive, radiation-free imaging technique, which can monitor regional lung ventilation and tidal volume distribution. However, there is no study on CF patients with EIT up to now. The aim of this pilot study was to examine the feasibility of EIT as an alternative clinical tool for CF patients.

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Organizational Data

  •   DRKS00003276
  •   2011/09/26
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  •   yes
  •   Approved
  •   294/10, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
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Secondary IDs

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Health Condition or Problem studied

  •   E84.0 -  Cystic fibrosis with pulmonary manifestations
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Interventions/Observational Groups

  •   The participants of this study will be recruited from the center for cystic fibrosis during their scheduled clinical visits. The patients should have received low-dose CT scan in the last 24 hours.
  •   During the clinical visit, the EIT examination is performed simultaneously with the lung function test. The additional time effort is limited to approx. 5 minutes. About 30 seconds will be required for the instrumentation and approx. 4:30 minutes for a baseline measurement during unexcited normal breathing.
    To achieve a higher power and to monitor disease progression, the same patients will be asked to take the same EIT examination by their next scheduled clinical visits.
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Diagnostic
  •   Other
  •   N/A
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Primary Outcome

Is the information obtained with electrical impedance tomography comparable to that obtained with computer tomography in respect of cystic fibrosis assessment?

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Secondary Outcome

Can additional information about lung function of the patients be obtained through the dynamic components of electrical impedance tomography analysis? Would this finding lead to a more accurate and robust description of patients’ condition during disease progression?

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2011/10/05
  •   12
  •   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

1. secured cystic fibrosis
2. scheduled or emergent CT examinations are presented.

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Exclusion Criteria

1. no secured cystic fibrosis
2. pregnancy and lactation period, and any contraindication to the use of EIT (pacemaker, automatic implantable cardioverter defibrillator, and implantable pumps).

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinikum der Ludwig-Maximilians-Universität
    • Mr.  Dr. med.  Rainald  Fischer 
    • Ziemssenstr. 1
    • 80338  München
    • Germany
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    • Hochschule Furtwangen
    • Mr.  Prof. Dr.  Knut  Möller 
    • Jakob Kienzle Str. 17
    • 78054  VS-Schwenningen
    • Germany
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  • start of 1:1-Block address scientific-contact
    • Klinikum der Ludwig-Maximilians-Universität
    • Mr.  Dr. med.  Rainald  Fischer 
    • Ziemssenstr. 1
    • 80336  München
    • Germany
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    • Klinikum der Ludwig-Maximilians-Universität
    • Mr.  Dr. med.  Rainald   Fischer 
    • Ziemssenstr. 1
    • 80336  München
    • Germany
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Sources of Monetary or Material Support

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    • Hochschule Furtwangen
    • Jakob-Kienzle Str. 17
    • 78054  VS-Schwenningen
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
  •   2011/11/01
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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.