Trial document




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  DRKS00009991

Trial Description

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Title

Regional ventilation distribution in patients with severe emphysema determined by electrical impedance tomography before and after endoscopic valve therapy for lung volume reduction

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Chronic obstructive lung diseases can aim to emphysema and breathing impairment. In order to improve lung function, exercise capacity and quality of life in patients with emphysema, special respiratory valves are placed in bronchial tubes for reduction of emphysematous lung regions.
In addition to this indicated procedure, an examination using the new imaging modality called electrical impedance tomography will be carried out before and after the placement of the endobronchial valves.
Electrical impedance tomography is a non-invasive regional imaging modality working in contrast to the well known X-ray and computed tomography without exposure to radiation. The measuring principle is based the determination of bioelectrical properties of the lung. For the measurement of the regional ventilation distribution, 16 conventional ECG electrodes will be placed around the chest. The electrical impedance tomography can determine the regional lung ventilation and its changes during spontaneous breathing.
The aim of the study is to check whether the valve effects affecting the regional ventilation distribution can be detected without radiation exposure, non-invasively and without time delay on the bedside after the therapeutic procedure using electrical impedance tomography. This could provide optimal monitoring during the procedure and optimize the treatment for patients with emphysema.

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Brief Summary in Scientific Language

Emphysema is a chronic pulmonary disease. The reasons are similar to those of chronic obstructive pulmonary disease (COPD): smoking, genetic predisposition (Alpha-1 antitrypsin deficiency), recurrent infections and chemical irritants. All medical treatments are used to reduce the symptoms. A cure is not possible at this time, unless there is the possibility of lung transplantation. One of the options for the treatment of emphysema is the surgical lung volume reduction, where 20-35% of the emphysematous lungs can be removed by surgery. This intervention may improve lung function, exercise capacity and quality of life but it is also associated with increased mortality. The high mortality occurs particularly in patients with homogeneous emphysema, very low values of the lung function parameter: forced expiratory volume in 1 second (FEV1) and very low levels of carbon monoxide (CO) diffusion capacity. These patients will not benefit from the surgery. Benefits show patients with heterogeneous emphysema and those with emphysema in the apical regions of the lungs.
Non-invasive treatment alternatives are the physiotherapy with appropriate breathing techniques, oxygen therapy and non-invasive home ventilation. In recent years, a new method has been introduced, thanks to the advancement of endoscopic technology, which represents an alternative to the surgical procedure. It is the endoscopic lung volume reduction. It has several options: the endobronchial valve or coils therapy, bronchoscopic thermal vapour ablation therapy and polymetric lung volume reduction. Only the endobronchial valve therapy is reversible. Which patient benefits mostly from which endoscopic method can only be decided on the basis of preliminary investigations. For this reason, the patients need a computed tomography (CT), a lung scintigraphy and a plethysmography. CT is associated with radiation exposure. Lung scintigraphy is a consuming investigation and it requires the inhalation of a gas mixture that includes a radioactive component. Plethysmography is non-invasive but it requires necessarily a good cooperation of patients.
Currently, there is a lack of a method that can non-invasively, radiation-free and bedside accompany endobronchial valve intervention for the determination of the regional ventilation distribution. For this reason, we want to check in our study whether the electrical impedance tomography - a functional imaging and non-invasive method for detection of regional dynamic volume and flow changes within the lungs - could be a useful application accompanying the endoscopic lung volume reduction intervention.
EIT could find an application in the immediate supervision of the regional ventilation, their effectiveness and the early detection of complications. This method relies on the detection of the bioelectric characteristics of the lungs. These properties vary depending on the expiration and inspiration and are recorded with the EIT as a relative impedance change. Thus, EIT is harmless for the examined subjects. We know from many studies that EIT can detect the regional ventilation distribution in children and in adults during spontaneous breathing and during mechanical ventilation. But there are no studies in patients with emphysema.
EIT could detect and monitor the regional ventilation distribution during endoscopi lung volume reduction. We want to use EIT immediately before and after the intervention. We hope the we could be able to detect lung volume changes and changes in the ventilation distribution without time delay and on the bedside.


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Organizational Data

  •   DRKS00009991
  •   2017/01/24
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  •   yes
  •   Approved
  •   D445/16, Ethikkommission der Christian-Albrechts-Universität zu Kiel
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Secondary IDs

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Health Condition or Problem studied

  •   J43 -  Emphysema
  •   J44 -  Other chronic obstructive pulmonary disease
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Interventions/Observational Groups

  •   Electical impedance tomography before and after endoscopic valve therapy in patients with severe emphysema
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Detection of the possible regional change in ventilation distribution after endoscopic valve therapy using electrical imepdance tomography (EIT) in patients with emphysema

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Secondary Outcome

Determination of regional heterogeneity of ventilation distribution after endoscopic valve therapy using new developped regional EIT-parameters in patients with emphysema

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2017/02/01
  •   20
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
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Additional Inclusion Criteria

- Written informed consent
- already authorised indication and information to patient about the endoscopic valve therapy
- Age ≥ 18 and ≤ 80 years
- COPD with emphysema requiring intervention

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Exclusion Criteria

- Withdrawal of informed consent
- Severe obesity
- Chest deformities
- Severe instable comorbidities
- Severe pulmonary hypertension
- Post lung resection condition
- Suspected tumour in the lungs
- Suspected pulmonary adhesions, scarring and bronchiectasis
- Collateral ventilation
- Incapacitated patients

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Addresses

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    • Klinik für Anästhesiologie und Operative Intensivmedizin, Universitätsklinikum Schleswig-Holstein, Campus Kiel
    • Arnold-Heller-Str. 3, Haus 12
    • 24105  Kiel
    • Germany
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    • Klinik für Anästhesiologie und Operative Intensivmedizin, Universitätsklinikum Schleswig-Holstein, Campus Kiel
    • Mr.  Dr. med.  Barbara  Vogt 
    • Arnold-Heller-Str. 3, Haus 12
    • 24105  Kiel
    • Germany
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    • Klinik für Innere Medizin I, Abteilung Pneumologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel
    • Mr.  Dr. med.  Lorenz  Balke 
    • Arnold-Heller-Str. 3, Haus 6
    • 24105  Kiel
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum S-H, Campus Kiel, Klinik für Anästhesiologie und Operative Intensivmedizin
    • Arnold-Heller-Str. 3, Haus 12
    • 24105  Kiel
    • 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.