Trial document





This trial has been registered retrospectively.
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  DRKS00013047

Trial Description

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Title

Intraoperative neuromonitoring of neurosurgical patients using a non-invasive tissue-photospectrometry technique

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Background:
Despite improvement in surgical techniques, intensive care, pharmacological treatment or diagnostic procedures, acute and life-threatening diseases of the central nervous system that require neurosurgical therapy have a high morbidity rate up to 66% for permanent neurological deficits and ultimately, death. Even in scheduled surgery of incidental findings, severe complications occur in up to 10% of cases. Major neurological deficits, such as paralysis, are important factors that have a major impact on treatment and recovery.

Primary Purpose:
Impairment of cerebral blood flow can lead to an insufficient oxygen supply of brain tissue. By continuous monitoring of neurological functions (“neuromonitoring”) and cerebral microcirculation, disturbances of cerebral blood flow can be detected during surgery. A novel, non-invasive combined laser-Doppler flowmetry and tissue-spectrophotometry technique could therefore predict potential blood flow impairment, which initiates specific therapy in the operating room reducing or preventing neurological deficits (“early warning system”). Additionally, the impact of accepted therapies on cerebral blood flow, oxygenation and metabolism is tested.

Study Participants
Patients undergoing scheduled intracranial surgery (group 1) or emergency surgery within 72 hours (group 2).

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Brief Summary in Scientific Language

Background:
Although neurosurgical procedures are considered safe, severe complications (i.e. cerebral ischemia, brain edema, intracranial hemorrhage, cerebral vasospasm) occurs in up to 10 %. In an emergency setting, the complication rate increases to up to 60%. Complications during surgery cause neurological deficits that require long-time care. Mechanisms that are causing damage to brain tissue are a) reduced cerebral blood flow, b) cerebral vasospasm and associated hypoxemia, and c) brain edema caused by an increased intra- or extracellular fluid accumulation, leading to a raised intracranial pressure. Here, we propose that changes in parameters of continuous neuromonitoring predict early changes of neurological complications. In this study, we will investigate the applicability of a novel non-invasive optic system used for intraoperative vascular neuromonitoring in neurosurgical patients. Furthermore, the findings will be compared to somatosensory evoked potentials (SEP) for the estimation of cerebral hypoperfusion – an established neuromonitoring technique.

Aims:
This observational study examines the intra- and extracranial application of a novel, non-invasive combined laser-Doppler flowmetry and tissue-spectrophotometry system in patients undergoing scheduled surgery (group 1) and emergency surgery (group 2) in cases with an expected high rate of life-threatening neurosurgical diseases (e.g. cerebral aneurysm, intracranial hemorrhage, cerebral ischemia). This device quantifies capillary-venous oxygen saturation, relative hemoglobin amount, blood cell velocity, and blood flow. These parameters will be correlated with the patient´s functional neurological outcome after surgery and during follow-up. We will thus test if non-invasive vascular neuromonitoring can be used for intraoperative risk stratification system to detect pathological changes in microcirculation as early as possible. In addition, this method is used to investigate the impact of standard therapy on local cerebral blood flow, oxygen supply, and metabolism to develop new therapeutic approaches in the future.

Study Participants:
Patients undergoing scheduled intracranial surgery (group 1) and patients, which are operated in an emergency setting within 72 hours (group 2).
Study Endpoints:
Primary endpoint (at the time of discharge/ max. 14 days after surgery): death or severe disability according to the modified Rankin Scale (mRS score 4, 5 or 6)
Secondary Endpoints:
1. Median time of survival
2. Degree of disability according the the Karnofsky Peformance Scale or the modified Rankin Scale.
3. Overall mortaility
4. Surgery-related complications

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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

  •   DRKS00013047
  •   2017/10/02
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  •   yes
  •   Approved
  •   4570, Ethik-Kommission der Friedrich-Alexander-Universität Erlangen-Nürnberg
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Secondary IDs

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Health Condition or Problem studied

  •   cerebral aneurysm, intracranial hemorrhage, cerebral ischemia, brain edema
  •   I67.1 -  Cerebral aneurysm, nonruptured
  •   I61.1 -  Intracerebral haemorrhage in hemisphere, cortical
  •   I63.9 -  Cerebral infarction, unspecified
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Interventions/Observational Groups

  •   A non-invasive combined Laser-Doppler-flowmeter and tissue-spectrophotometer is used in patients undergoing scheduled intracranial surgery (group 1) to record local cerebral microcirculation intraoperatively. At the same time, somatosensory evoked potentials (SEP) as an established neuromonitoring technique were measured.
  •   A non-invasive combined Laser-Doppler-flowmeter and tissue-spectrophotometer is used in patients which underwent neurosurgery in an emergency setting within 72 hours (group 2). Pathological changes of local cerebral microcirculation during intraoperative measurements are compared to changes of somatosensory evoked potentials (SEP), which are recorded at the same time.
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Diagnostic
  •   Other
  •   N/A
  •   No
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Primary Outcome

Primary endpoint (at the time of discharge/ max. 14 days after surgery): death or severe disability according to the modified Rankin Scale (mRS score 4, 5 or 6)

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Secondary Outcome

Secondary Endpoints (after 3, 6 an 12 months):
1. Median time of survival
2. Degree of disability according the the Karnofsky Perormance Scale or the modified Rankin Scale.
3. Overall mortaility
4. Surgery-related complications

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/10/04
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

a) All participants of this study have to be either fully competent or provide a legal guardian for medical concerns
b) Written informed consent of the participant or his/her legal guardian
c) Age of 18 to 85 years, both genders.
d) Depending on the study phase, two groups are investigated:

Group 1: Patients undergoing a scheduled neurosurgical operation such as resection of a supra- or infratentorial lesion (meningeoma, vestibular schwannoma, pituitary adenoma, arachnoid cyst)

Group 2: Patients with life-threatening neurosurgical disease which requires emergency surgery within 72 hours such as intracranial hemorrhage or brain tumors with mass effect.

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Exclusion Criteria

a) decompensated liver- or renal disease
b) acute coronary syndrome
c) severe comorbidity (mRS ≥ 3)
d) pregnancy
e) last participation in a trial <6 months

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Addresses

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    • Neurochirurgische Klinik, Universitätsklinikum Erlangen
    • Mr.  Prof. Dr. med.  Michael  Buchfelder 
    • Schwabachanlage 6
    • 91054  Erlangen
    • Germany
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    • Anästhesiologische Klinik, Universitätsklinikum Erlangen
    • Mr.  Prof. Dr. med.  Hubert  Schmitt 
    • Krankenhausstraße 12
    • 91054  Erlangen
    • Germany
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    • Paracelsus-Klinik Osnabrück, Neurochirurgische Abteilung
    • Mr.  Dr. med.  Björn  Sommer 
    • Am Natruper Holz 69
    • 49076  Osnabrück
    • Germany
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    • Paracelsus-Klinik Osnabrück, Neurochirurgische Abteilung
    • Mr.  Dr. med.  Björn  Sommer 
    • Am Natruper Holz 69
    • 49076  Osnabrück
    • Germany
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Sources of Monetary or Material Support

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    • Vorsitzender der Vergabekomission derJohannes und Frieda Marohn-Stiftung an der Friedrich-Alexander-Universität Erlangen-Nürnberg
    • Mr.  Prof. Dr.  Christian  Alzheimer 
    • Universitätsstrasse 19
    • 91054  Erlangen
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2017/10/21
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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.