Trial document





This trial has been registered retrospectively.
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  DRKS00010428

Trial Description

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Title

Focused assessment of sonographic pathologies in the intensive care unit

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Trial Acronym

FASP-ICU

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URL of the Trial

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Brief Summary in Lay Language

In this scientific study we want to evaluate if the routine use of ultrasound in intensive care patients can have positive effects on their treatment. A new sonographic protocol that might potentially reveal pathologies early in the course of a disease and at a potentially treatable time is to be evaluated. Study participation is not associated with any hazards. Ultrasonic waves are not harmful for the human body. The Examinations will be performed by an intensive care specialist with an additional qualification in medical ultrasound in the intensive care unit. The examinations will be carried out on the day of admission and on days 3, 6, 10 and 15 of the intensive care stay. In these examinations the neuro system, heart, lungs, blood vessels and the abdomen will be thoroughly examined. If pathological findings are encountered the attending physician will be informed so that he/she might adjust the treatment accordingly. The examinations will be carried out in the supine or left lateral position. There is nothing that needs to be considered before or after the examination.

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Brief Summary in Scientific Language

Focused critical care echocardiography (CCE) and general critical care ultrasonography (GCCUS) proofed to be valuable tools in emergency and critical care medicine. Ultrasonographic techniques are increasingly employed to detect acute deteriorations of vital organ systems in intensive care unit- (ICU) patients. Recommendations and training schemes have been published to guide the implementation into clinical routine and educate intensivists in these techniques. However, with only limited data available, these recommendations and training schemes cannot yet be evidence based. Therefore, our aim is to define the range and prevalence of pathologies detectable by whole body ultrasound (WBU; CCE + GCCUS) in the ICU and to develop a simple and fast bedside examination protocol. We will evaluate WBU as a routine surveillance technique. A protocol for focused assessments of sonographic pathologies in intensive care units (FASP-ICU) was developed to evaluate 99 predefined sonographic entities on the day of admission and on days 3, 6, 10 and 15 of a patient’s stay in the ICU. Therapy changes related to findings of the FASP-ICU protocol execution will be documented.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00010428
  •   2017/04/07
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  •   yes
  •   Approved
  •   25/6/13, Ethik-Kommission der Medizinischen Fakultät der Georg-August-Universität Göttingen
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Secondary IDs

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Health Condition or Problem studied

  •   J00-J99 -  Diseases of the respiratory system
  •   I00-I99 -  Diseases of the circulatory system
  •   Patient in intensive care unit
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Interventions/Observational Groups

  •   Execution of a whole-body ultrasound protocol (neurosonography, pulmonary ultrasound, critical care echocardiography, ultrasound of the abdomen, vessel ultrasound) on the day of admission on the intensive care unit and on day 3, 6, 10 and 15 of the intensive care stay. Documentation of therapy changes based on the ultrasonographic findings detected by the FASP-ICU protocol. Completion of a questionnaire by the attending resident and attending consultant regarding usefulness, therapy changes, etc.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   IV
  •   No
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Primary Outcome

- Frequency of therapy changes after execution of the FASP-ICU protocol (day of admission to the intensive care unit and days 3, 6, 10 and 15 of the intensive care stay)
- Incidence/magnitude and frequency of sonographic ascertainable pathologies on every examination day
- Usefulness of the sonographic evaluation by the FASP-ICU protocol (questionnaire) answered by the attending resident and attending consultant

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Secondary Outcome

- Duration for executing the FASP-ICU protocol on the different examination days
- Dynamics of sonographic pathologies on the different examination days
- Sonographic image quality for different organ systems on different examination days
- Correlation of critical care parameters/scores (SAPS II, etc.) with sonograhic pathologies
- Accuracy of preexisting sonographic examinations and diagnoses
- Extensive subanalysis of the sonographic pathologies for different organ systems related to appearance/dynamic/treatment/therapeutic intervention/correlation with laboratory parameters and results of other examinations (chest x-ray, CT, etc.), etc.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/10/01
  •   111
  •   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

Consecutive patients that are admitted to two anesthesiology supervised intensive care units

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Exclusion Criteria

- no consent for study participation
- palliative treatment

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Addresses

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    • Universitätsmedizin Göttingen
    • Robert-Koch-Straße 40
    • 37099  Göttingen
    • Germany
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    • Klinik für Anästhesiologie Universitätsmedizin Göttingen
    • Mr.  Dr. med.  Stefan  Schmidt 
    • Robert-Koch-Straße 40
    • 37099  Göttingen
    • Germany
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    • Universitätsklinikum Göttingen Klinik für Anästhesiologie
    • Mr.  Dr. med.  Stefan  Schmidt 
    • Robert-Koch-Str. 40
    • 37099  Göttingen
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsmedizin Göttingen
    • Robert-Koch-Straße 40
    • 37099  Göttingen
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2014/11/10
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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.