Trial document




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  DRKS00015621

Trial Description

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Title

„REDUCE – re-evaluation of the diagnostic value of routine chest x-rays in intensive care environments “

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Trial Acronym

REDUCE

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Comparison of the utility of routine chest x-ray controls of patients on intensive care units compared to a more restrictive approach (according to the ACR-guidelines) with a reduced number of chest x-rays. Training of the physicians of the ICU and optimized e-filling for chest x-rays to reduce radiation exposure.

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Brief Summary in Scientific Language

A reduction of (non-ACR guideline based) chest x-ray routine controls leads to a reduction of 1) unnecessary radiation exposure 2) unnecessary potential harm for the Patient in positioning maneuvers and 3) unnecessary involvement of employees. Physicians on the ICU gain knowledge for a stricter indication for chest x-rays (according to ACR guidelines) with the structural changes implemented in our study, which reduces radiation exposure.

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Organizational Data

  •   DRKS00015621
  •   2019/02/20
  •   [---]*
  •   yes
  •   Approved
  •   18-733, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
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Secondary IDs

  •   interne StudienID  (LMU-RAD00139 )
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Health Condition or Problem studied

  •   J94 -  Other pleural conditions
  •   J93 -  Pneumothorax
  •   J95 -  Postprocedural respiratory disorders, not elsewhere classified
  •   J81 -  Pulmonary oedema
  •   R57.0 -  Cardiogenic shock
  •   R57.2 -  Septic shock
  •   J15.9 -  Bacterial pneumonia, unspecified
  •   J96.90 -  [generalization J96.9: Respiratory failure, unspecified]
  •   J96.91 -  [generalization J96.9: Respiratory failure, unspecified]
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Interventions/Observational Groups

  •   The current situation of routine chest x-rays on the ICUs ITS2, 3 and 5 is evaluated with a retrospective analysis of anonymised patient data of 3 months.
  •   In a prospective approach the e-filling of indications for chest x-rays is modified for 3 months on the ICUs ITS 2, 3 and 5 with stricter indications (according to the ACR-guidelines) leading to a reduction of chest x-rays followed by a comparison of both groups (radiation exposure, outcome and cost-effectiveness).
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Health economics
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Primary endpoints: number of chest x-rays per patient per day on ICU and radiation dose (cGy/cm2). The first group (all patients admitted to the ICU during 3 months) is evaluated retrospectively. The second group (all patients admitted to the ICU during 3 months) is prospectively included in this study. The number of chest-x-rays and the radiation dose per patient is evaluated at the end of the 3-months, there is no further follow up of included patients. The number of chest-x-rays and the radiation dose per chest-x-ray (cGy/cm2) is documented in our radiological computer system.

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Secondary Outcome

Comparison of a) mortality (outcome), b) hours on the ventilator, c) re-intubations after extubation, d) re-admission on ICU, e) necessary interventions (pleural drainage etc.) f) cost-effectiveness

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2019/03/01
  •   500
  •   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

All patients who are admitted to the ICU ITS 2, 3 or 5 during the investigation period (and for the retrospective part of our study all patients who were admitted to the ICU ITS 2, 3 or 5 during a time period of 3 months before the recuritment of patients for the prospective analysis). Patients of the prospective group are included for 3 months and the investigation ends with the last day of the prespecified time period.

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Exclusion Criteria

No admission to the ICU during that time

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Addresses

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    • Klinikum der Universität München, Campus Großhadern
    • Marchioninistraße 15
    • 81377  München
    • Germany
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    • Klinik und Poliklinik für Radiologie Klinikum der Universität München Campus Großhadern
    • Mr.  Prof.  Jens  Ricke 
    • Marchioninistr. 15
    • 81377  München
    • Germany
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    • Klinik und Poliklinik für Radiologie Klinikum der Universität München
    • Mr.  Daniel  Puhr-Westerheide 
    • Marchioninistr. 15
    • 81377  München
    • Germany
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Sources of Monetary or Material Support

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    • Klinik und Poliklinik für Radiologie Klinikum der Universität München Campus Großhadern
    • Mr.  Prof.  Jens  Ricke 
    • Marchioninistr. 15
    • 81377  München
    • Germany
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    •   (089) 4400-4400 72750
    •   [---]*
    •   [---]*
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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.