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| Name | Class |
|---|---|
| Klinikum Stuttgart | OTHER |
| Klinikum Darmstadt | OTHER |
| University Medical Center Goettingen | OTHER |
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HS-1000 device, a proprietary new non-invasive brain monitor, is expected to safely and accurately monitor physiological signs of the brain with minimal discomfort to patients, providing information about normal or abnormal brain-related conditions and providing decision-making support for physicians. Investigators hypothesis that the HS-1000 is capable of detecting and monitoring various neuropathologies, using the acoustic raw data derived from the noninvasive procedure.
Non-invasive modality for brain monitoring can potentially serve as a major contribution to conventional monitoring techniques for patients with neuropathologies, to assure minimal discomfort to the bedbound patients, and provide information about critical physiological signs to the physicians. The lack of a precise diagnostic technique for numerous neuropathologies for patients in neurosurgical clinics can further hinder therapeutic effectiveness and, therefore, influence patient recovery and healing. Neuro-critical care involves monitoring standard vital signs and cerebral physiological signs, mainly focusing on intracranial pressure (ICP), temperature, cerebral blood flow velocity, arterial blood pressure, cerebral perfusion pressure, brain tissue oxygenation etc. The collaboration of state of the art brain monitoring vary between different intensive care units serves a significant drawback in some cases, as accuracy of diagnosis and monitoring is challenged and thereby there is an eminent need for interrelationship brain monitoring approach. That can also be leveraged by applying the monitoring noninvasively, as it particularly beneficial for clinical applications that routinely require the inevitable and dynamic transport of patients between hospital units (imaging, surgical room, etc.).
Subjects who meet the inclusion and exclusion criteria for this study, with a signed informed consent form, will be enrolled into the study. Eligible patients will be divided to 2 groups:
The non-invasive measurements recording sessions will be according to the protocol scheme per each group:
For all eligible patients, non-invasive measurements by the HS-1000 device will be conducted in parallel with the standard monitoring modalities, as used at the site without any change in the patient's management.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HS-1000 recording | Experimental | Non-invasive measurements duration with HS-1000 device will be for at least 30 minutes and up to 1 hour of aggregate recording either continuously in the event the patient's clinical condition allows it or in separate recording iterations in the event patient's condition will not allow continuous recording. For each patient, there may be several monitoring intervals from three times a day and up to as long as the patient undergoes brain monitoring, per the discretion of the investigator, patient and/or family members. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HS-1000 recording | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of recordings that correlate to neuropathology | Demonstrate the HS-1000 performance and accuracy in brain monitoring | up to 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | 48 hours from the end of monitoring with the HS-1000 | |
| Rate of ear infections/irritations graded by none/mild/moderate and severe | 48 hours from the end of monitoring with the HS-1000 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thomas Swanson | Contact | thomas@head-sense-med.com | ||
| Dana Hromyak | Contact | 216-526-8534 | dana@head-sense-med.com |
| Name | Affiliation | Role |
|---|---|---|
| Oliver Ganslandt, Prof. | Klinikum Stuttgart | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Darmstadt | Recruiting | Darmstadt | 64283 | Germany |
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| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D013345 | Subarachnoid Hemorrhage |
| D020301 | Vasospasm, Intracranial |
| D006849 | Hydrocephalus |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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| University Hospital Erlangen | Recruiting | Erlangen | Germany |
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| Universitätsklinik Göttingen | Recruiting | Göttingen | 37075 | Germany |
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| Klinikum Stuttgart | Recruiting | Stuttgart | Germany |
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| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |