Trial document




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  DRKS00009635

Trial Description

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Title

Validation of postinterventional lung ultrasound compared to chest X-ray to detect and treat a pneumothorax after bronchoscopic interventions

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Trial Acronym

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URL of the Trial

http://

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

All procedures associated with an increased risk of pneumothorax will be monitored by ultrasound. This includes any diagnostic biopsy in previously unclear ILD & ELVR with valves or RePneu-Coils.
An ultrasound scan with a 10 MHz linear transducer is initially performed immediately after the intervention in the bronchoscopy suite. As a control we use the chest X-ray recording.
If a pneumothorax can be detected, carried in the recovery room in stable vital signs, the usual conservative therapy (LTOT, bed rest, antitussives).
In the case of pneumothorax the "Lung Point", which represents the transition from pneumothorax to lung tissue, is marked with skin marks (pin or patch), and after 2 h checked before laying out of the recovery room. All investigations should be carried out by the same person.
When ultrasound progressive lesion compared to directly postinterventional setting (larger pneumothorax, clinical signs of stress component with increased HF> 10%, SO2 waste or increasing O2 demand) there is a relief by means of one-time puncture or in clinically thereafter further restriction also drainage therapy. Conservatively treated patients will be controlled by ultrasound after 24 hours again. In a CRF-sheet documentation is done.
Goals
1. Establishment of sonography in interventional setting
2. In addition to the X-ray recording the classification of sonography is to serve as a tool for risk stratification. The direct comparison of methods with the chest X-ray, if necessary, depending on the engagement, should document the importance of side-effect free sonography. It is expected an immediate detection in case of pneumothorax, so in the absence thereof omitted another chest X-ray and radiation exposure for the patient can be reduced.

Literature:

1) Alrajab et al, Crit Care 2013
2) Ding et al, Chest 2011
3) Reissig et al., Eur J Radiol 2005
4) Kumar et al, J Bronchol Intervent Pulmonol 2015

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Organizational Data

  •   DRKS00009635
  •   2015/11/25
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  •   yes
  •   Approved
  •   15-6572-BO, Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
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Secondary IDs

  •   U1111-1176-9066 
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Health Condition or Problem studied

  •   Iatrogenical Pneumothorax
  •   J93 -  Pneumothorax
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Interventions/Observational Groups

  •   In bronchoscopy with increased risk of pneumothorax transthoracic ultrasound examinations are performed immediately after the intervention and 2 h after. A comparison is made with the standard method, the chest X-ray.
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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)
  •   IV
  •   N/A
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Primary Outcome

Non-inferiority of postinterventional thoracic ultrasound in the detection of an iatrogenic pneumothorax in comparison to conventional chest-X-ray.

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/11/04
  •   100
  •   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

Bronchoscopical Interventions with increased risk of iatrogenic pneumothorax
- ELVR with valves and RePneu-Coils
- TBB with forceps or cryo

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Exclusion Criteria

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Ruhrlandklinik Essen
    • Mr.  Dr. med.  Stephan  Eisenmann 
    • Tüschener Weg 40
    • 45239  Essen
    • Germany
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    • Ruhrlandklinik Essen
    • Mr.  Dr. med.  Stephan  Eisenmann 
    • Tüschener Weg 40
    • 45239  Essen
    • Germany
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    • Ruhrlandklinik Essen
    • Mr.  Dr. med.  Stephan  Eisenmann 
    • Tüschener Weg 40
    • 45239  Essen
    • Germany
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Sources of Monetary or Material Support

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    • Ruhrlandklinik Essen
    • Mr.  PD Dr. med.  Kaid  Darwiche 
    • Tüschener Weg 40
    • 45239  Essen
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2016/08/08
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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.