A New Multi-parameter Monitoring System Applying Near Infrared Spectroscopy and Indocyanine Green to Detect Cerebrovascular Events in Patients With Subarachnoid Hemorrhage
NeMo Probe
Brain Diseases+8
+ Cardiovascular Diseases
+ Central Nervous System Diseases
Diagnostic Study
Summary
Study start date: March 1, 2013
Actual date on which the first participant was enrolled.To assess the feasibility of a new brain tissue probe for multi-parameter neuromonitoring (NeMo Probe) and the accuracy of measurement values. To demonstrate the ability of the NeMo probe to detect changes in cerebral hemodynamics and oxygenation during cerebrovascular events monitored with established methods including brain tissue oxygenation tension and microdialysis
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.3 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Diagnostic Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: Males and females aged 18-75 years (inclusive) Patients with high-grade subarachnoid hemorrhage (WFNS 4-5) Decreased level of consciousness with the need for intracranial pressure monitoring Successful exclusion of the ruptured aneurysm with clipping or coiling Women of childbearing potential must have a negative serum pregnancy test Written informed consent obtained by a legal representative Exclusion Criteria: Significant kidney and/or liver disease Any severe unstable concomitant condition or disease (e.g. cancer, coronary disease) or chronic condition (e.g. psychiatric disorder, chronic obstructive pulmonary disease Grade II, chronic heart failure > NYHA II) Cerebrospinal fluid infection or signs of meningoencephalitis Acute respiratory distress syndrome (ARDS), pulmonary edema Preexisting coagulation disorder Patients with current alcohol or drug abusus or dependence Patients with a history of hypersensitivity against indocyanine green or sodium iodine Patients with thyroid disease causing hyperthyroidism Breast-feeding women Patients committed to an institution based on official directive or court order
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Department of Neurosurgery, University Hospital Heidelberg
Heidelberg, GermanyOpen Department of Neurosurgery, University Hospital Heidelberg in Google Maps