Trial document





This trial has been registered retrospectively.
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  DRKS00010482

Trial Description

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Title

Analysis of intracranial pressure curve to determine the brain compliance and vasoreactivity in patients with implanted intracranial pressure probe to monitor the intracranial pressure

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Patients who are unconscious with brain swelling or cerebral infarction due to cerebral hemorrhage, a severe craniocerebral trauma, are supplied to monitor the intracranial pressure with brain pressure probe in the ICU. By monitoring the intracranial pressure and the arterial blood pressure curve, the optimization of the intracranial pressure therapy is possible.
Patients are usually ventilated and stored with a slightly elevated upper body (30 °) to relieve intracranial pressure.
So far, the treatment of patients who are supplied with an intracranial pressure probe due to a brain injury, is only depending on the peak value of the measured pressure in the brain. The course of the intracranial pressure curves is irrelevant during the intracranial pressure curve but it is assumed that more information is included. There are many factors influencing the curve such as the cerebral circulation, breathing and the swelling state of the brain. The aim of the study is to identify these factors.

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Brief Summary in Scientific Language

The threshold of brain pressure for the individual patient is not previously determined, the treatment of intracranial pressure is made solely dependent on the peak values ​​of the measured pressure. A peak pressure of 10 mm Hg. is considered increased. Intervenes is from a pressure of 15 mm Hg. The intracranial pressure is subject to constant fluctuations. The intracranial pressure curve is so far not included in the therapeutic considerations. but implicit are in the curve information such as the vascular resistance and compliance of the brain contain. Thus, it is expected that in the amplitude of the intracranial pressure curve implicit information on the compliance and in the amplitude over the length vascular resistance are included.

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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

  •   DRKS00010482
  •   2017/02/02
  •   [---]*
  •   yes
  •   Approved
  •   178/2015, Ethik-Kommission der Universität Witten/Herdecke
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Secondary IDs

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Health Condition or Problem studied

  •   G93 -  Other disorders of brain
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Interventions/Observational Groups

  •   Prospective , exploratory data collection (max. 10 day) and analysis on trend differences of
    - intra cranial pressure curve
    -arterial pressure curve
    -oxygen saturation
    -EKG
    -ventilation configuration
    -medications and their doses
    -therapeutic , manual intensive medical care
    - documentation of the lowering of the bed´s head rest
    -Documentation of the height difference before and after lowering the head rest of the bed
    - measurement of the blood flow ( A. cerebri media and a. carotis on both sides ) before and after changing the ventilation setting
    - Blood gas analysis (pCO2 and pO2)
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Exploratory data collection and analysis on trend differences.

Objectives:

1.Can the brain's compliance be calculated automatically from the history of brain pressure curves?
2. Can the brain´s perfusion be calculated automatically from the history of brain pressure curves?

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Secondary Outcome

1. Do the administered drugs
(incl . anthroposophic drugs) have an influence on the intracranial pressure curves and their history?
2. Do therapeutic , manual intensive medical care therapies, brightness level ( day / night) and volume level have an influence on the parameters: respiration , ECG history, art . RR, oxygen saturation, ICP?
3. Do ventilation parameters have an effect of the intracranial pressure?

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2016/06/09
  •   10
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

-Patients with brain injury and intracranial pressure tube
-Age 18-100

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Exclusion Criteria

Participation in another observational study or clinical trial

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Addresses

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    • Abteilung für Neurochirurgie, Gemeinschaftskrankenhaus Herdecke
    • Mr.  Porf. Dr.  Wolfgang  Scharbrodt 
    • Gerhard-Kienle-Weg 4
    • 58313  Herdecke
    • Germany
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    • Abteilung für Neurochirurgie, Gemeinschaftskrankenhaus Herdecke
    • Mr.  Porf. Dr.  Wolfgang  Scharbrodt 
    • Gerhard-Kienle-Weg 4
    • 58313  Herdecke
    • Germany
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    • Abteilung für Neurochirurgie, Gemeinschaftskrankenhaus Herdecke
    • Mr.  Porf. Dr.  Wolfgang  Scharbrodt 
    • Gerhard-Kienle-Weg 4
    • 58313  Herdecke
    • Germany
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Sources of Monetary or Material Support

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    • Abteilung für Neurochirurgie, Gemeinschaftskrankenhaus Herdecke
    • Mr.  Porf. Dr.  Wolfgang  Scharbrodt 
    • Gerhard-Kienle-Weg 4
    • 58313  Herdecke
    • Germany
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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.