Back to resultsA New Minimal-invasive Brain Tissue Probe Applying Near Infrared Spectroscopy
Primary Purpose
Spontaneous Subarachnoid Hemorrhage
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
NeMo Probe
Sponsored by
About this trial
This is an interventional diagnostic trial for Spontaneous Subarachnoid Hemorrhage
Eligibility 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
Sites / Locations
- Department of Neurosurgery, University Hospital Heidelberg
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
NeMoProbe
Arm Description
The NeMo System is used for intracranial pressure (ICP) and brain temperature monitoring, as well as the determination of the brain tissue oxygenation saturation (SbtO2) and cerebral blood flow. The sensors for NIRS are implemented into a conventional brain tissue probe for ICP monitoring (NeMo Probe).
Outcomes
Primary Outcome Measures
To assess the feasibility of the neuromonitoring system and accuracy of the measurement values
Feasibility: User acceptance rate in comparison to conventional probes for ICP-monitoring. The following parameters will be analysed:
Incidence of concerns of users in relation to the installation of the NeMo System
Incidence of concerns of users in relation to the function of the NeMo System Incidence of concerns of users in relation to the removal of the NeMo System
User-friendliness with a 3-graded scale (equal, better, worse) compared to conventional probes for ICP monitoring Accuracy of measurement values: Results from repeated measurements of mttICG, CBV, and CBF.
Safety endpoints:
-Adverse events profile (including adverse device effects): Incidence of complications (infections, brain tissue damage, hemorrhage) in comparison to historical series (conventional probes for ICP-monitoring):
Secondary Outcome Measures
To demonstrate the ability of the neuromonitoring system to detect cerebrovascular events in patients with subarachnoid hemorrhage
Results concerning the response to cortical spreading depolarization (CSD) monitored with electrocorticography (ECoG):
Increase of brain tissue oxygenation (SbtO2), total hemoglobin (dHbtotal, aHbtotal), CBV, CBV Hb and CBF >20% Decrease of SbtO2, dHbtotal, aHbtotal, CBV, CBV Hb and CBF >20% Changes of SbtO2, dHbtotal, aHbtotal, CBV, CBV Hb and CBF <20%
Results concerning the sensitivity and specificity to detect delayed cerebral ischemia (DCI) monitored with ptiO2 and MD:
Correlation of CBF values <15 ml/100g/min with defined criteria for DCI (ptiO2 <15 mmHg, Gluc brain<0.7 mmol/l, Lactate-Pyruvate-Ratio >40), number of false negative and false positive events, Receiver Operating Characteristic (ROC) curve.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01801306
Brief Title
A New Minimal-invasive Brain Tissue Probe Applying Near Infrared Spectroscopy
Official Title
A New Multi-parameter Monitoring System Applying Near Infrared Spectroscopy and Indocyanine Green to Detect Cerebrovascular Events in Patients With Subarachnoid Hemorrhage
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NeMoDevices AG
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spontaneous Subarachnoid Hemorrhage
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NeMoProbe
Arm Type
Other
Arm Description
The NeMo System is used for intracranial pressure (ICP) and brain temperature monitoring, as well as the determination of the brain tissue oxygenation saturation (SbtO2) and cerebral blood flow. The sensors for NIRS are implemented into a conventional brain tissue probe for ICP monitoring (NeMo Probe).
Intervention Type
Device
Intervention Name(s)
NeMo Probe
Intervention Description
A new minimal-invasive brain tissue probe applying near infrared spectroscopy
Primary Outcome Measure Information:
Title
To assess the feasibility of the neuromonitoring system and accuracy of the measurement values
Description
Feasibility: User acceptance rate in comparison to conventional probes for ICP-monitoring. The following parameters will be analysed:
Incidence of concerns of users in relation to the installation of the NeMo System
Incidence of concerns of users in relation to the function of the NeMo System Incidence of concerns of users in relation to the removal of the NeMo System
User-friendliness with a 3-graded scale (equal, better, worse) compared to conventional probes for ICP monitoring Accuracy of measurement values: Results from repeated measurements of mttICG, CBV, and CBF.
Safety endpoints:
-Adverse events profile (including adverse device effects): Incidence of complications (infections, brain tissue damage, hemorrhage) in comparison to historical series (conventional probes for ICP-monitoring):
Time Frame
Day 90 after Removal of Medical Device
Secondary Outcome Measure Information:
Title
To demonstrate the ability of the neuromonitoring system to detect cerebrovascular events in patients with subarachnoid hemorrhage
Description
Results concerning the response to cortical spreading depolarization (CSD) monitored with electrocorticography (ECoG):
Increase of brain tissue oxygenation (SbtO2), total hemoglobin (dHbtotal, aHbtotal), CBV, CBV Hb and CBF >20% Decrease of SbtO2, dHbtotal, aHbtotal, CBV, CBV Hb and CBF >20% Changes of SbtO2, dHbtotal, aHbtotal, CBV, CBV Hb and CBF <20%
Results concerning the sensitivity and specificity to detect delayed cerebral ischemia (DCI) monitored with ptiO2 and MD:
Correlation of CBF values <15 ml/100g/min with defined criteria for DCI (ptiO2 <15 mmHg, Gluc brain<0.7 mmol/l, Lactate-Pyruvate-Ratio >40), number of false negative and false positive events, Receiver Operating Characteristic (ROC) curve.
Time Frame
Day 90 after Removal of Medical Device
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Seule, MD
Organizational Affiliation
Department of Neurosurgery, University Hospital Heidelberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurosurgery, University Hospital Heidelberg
City
Heidelberg
ZIP/Postal Code
69221
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
A New Minimal-invasive Brain Tissue Probe Applying Near Infrared Spectroscopy
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