Intraoperative neuromonitoring of neurosurgical patients using a non-invasive tissue-photospectrometry technique
- Conditions
- cerebral aneurysm, intracranial hemorrhage, cerebral ischemia, brain edemaI67.1I61.1I63.9Cerebral aneurysm, nonrupturedIntracerebral haemorrhage in hemisphere, corticalCerebral infarction, unspecified
- Registration Number
- DRKS00013047
- Lead Sponsor
- eurochirurgische Klinik, Universitätsklinikum Erlangen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 74
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.
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Secondary Endpoints (after 3, 6 an 12 months):<br>1. Median time of survival<br>2. Degree of disability according the the Karnofsky Perormance Scale or the modified Rankin Scale.<br>3. Overall mortaility<br>4. Surgery-related complications