A New Multi-parameter Neuromonitoring System to Save Patients' Lives in Stroke and Brain Injury

Subarachnoid Hemorrhage Clinical Trial

Official title:

A New Multi-parameter Neuromonitoring System to Save Patients' Lives in Stroke and Brain Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01802762
• Other study ID #: P-1.000_NeMo_C001 / MUG
• Secondary ID: E!6526_OPTO-BRAI
• Status: Completed
• Phase: N/A
• First received: February 24, 2013
• Last updated: September 4, 2017
• Start date: January 2013
• Est. completion date: May 2017

Study information

• Verified date: September 2017
• Source: NeMoDevices AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess the feasibility of a new neuromonitoring system (NeMoSystem including NeMo Probe and NeMo Patch) and the accuracy of the measurement values (cerebral blood flow (CBF); cerebral blood volume (CBV)) obtained.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: May 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Adult male or female patient, = 18 and = 75 years

2. Patient with severe SAH (GCS = 12) or severe TBI (GCS = 8)

3. Decreased level of consciousness with the need for ICP monitoring for an estimated duration of more than 3 days

4. Negative pre-treatment serum pregnancy test for female patients with childbearing potential

5. In patients with severe SAH or severe TBI with need for ICP monitoring an acute emergency situation exists. The inclusion follows

Exclusion Criteria:

1. Known kidney disease, defined as plasma creatinine > 120 µmol/l

2. Known liver disease, defined as GOT > 200U/l

3. History of allergic disorders, including allergic reactions against contrast agents containing iodine, against ICG and against plasters, as well as patients with thyroid disease causing hyperthyroidism

4. Pre-existing disability and/or legal representative

5. Participation in another interventional clinical trial within the last 30 days before start of treatment

Related Conditions & MeSH terms

• Brain Injuries
• Hemorrhage
• Optical Imaging
• Subarachnoid Hemorrhage

Intervention

Device:
• NeMo Patch and NeMo Probe
A plaster based patch (NeMo Patch) and a combined probe for ICP monitoring and near infrared spectroscopy (NIRS) are applied as sensors. Data are collected by a NIRS instrument (NeMo Control Unit)

Locations

Country	Name	City	State
Austria	Dept. of Neurosurgery, Medical University of Graz	Graz
Switzerland	Neurointensive Care Unit, University Hospital Zurich	Zurich

Sponsors (3)

Lead Sponsor	Collaborator
NeMoDevices AG	Medical University of Graz, University of Zurich

Countries where clinical trial is conducted

Austria,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the feasibility of the neuromonitoring system and the accuracy of the measurement values.	Feasibility: User acceptance: For NeMo Probes in comparison to conventional probes for intracranial pressure (ICP-) monitoring; for NeMo Patch in comparison to patches for electroencephalography (EEG) monitoring.; Detailled evaluation of user acceptance: Incidence of concerns of users in relation to the installation, function and removal of the NeMo System (= NeMo Probe, NeMo Patch, NeMo Control Unit and NeMo Software pre-installed on a Medical PC); User-friendliness with a 3-graded scale (equal, better, worse) compared to conventional devices; Accuracy of measurements: -Patients: Results from repeated measurements of mean transit time of ICG (mttICG), cerebral blood flow (CBF) and cerebral blood volume (CBV); Safety parameters: Incidence of complications (infections, brain tissue damage, haemorrhage) compared to historical series (patches for EEG and for BIS measurements; conventional probes for ICP monitoring)	Day 28 after removal of medical device
Secondary	To demonstrate the ability of the neuromonitoring system to detect secondary ischemic events in patients with severe subarachnoid haemorrhage (SAH) or severe traumatic brain injury (TBI).	Results concerning sensitivity and specificity to detect symptomatic vasospasm in patients with subarachnoid hemorrhage (SAH) (correlation of events with CBF values < 15 ml/100g/min with defined criteria for vasospasm) Results concerning sensitivity and specificity to detect secondary infarctions and critical ICP values in TBI patients (correlation of events with CBF values < 15 ml/100g/min with defined criteria for secondary infarction) Results from repeated measurements for the difference between measurement values obtained with the NeMo Patch and the NeMo Probe, quantified with mathematical models	Day 28 after removal of medical device

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