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To evaluate the performance characteristics of the Smart External Drain (SED) compared with standard EVD drains in the hospital setting, specifically:
In this two day clinical trial, subjects will be observed on Day 1 of study during their routine treatment and using their already existing EVD. On Day 2 of study; subjects will be switched to the Smart External Drain for monitoring and management of ICP and CSF
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm study | Other | Single Arm study In this study, the subject will act as their own control. On Day 1 of the two day study, the subject will be observed while treated on their standard EVD. On Day 2, the subject will be treated with the Smart External Drain (SED). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smart External Drain - SED | Device | Subject will be treated on Day 2 with the SED. ICP and CSF volumes will be recorded at prespecified intervals while subject is stationary and while subject is engaged in protocol-driven directed movements. |
| Measure | Description | Time Frame |
|---|---|---|
| Staff interactions | Average number of staff interactions per patient with standard EVD compared to intervention, the Smart External Drain (SED) | Two Days |
| Measure | Description | Time Frame |
|---|---|---|
| Staff Time | Total minutes spent by staff interacting with standard EVD compared to SED | Two Days |
| Safety | Number of Participants with Adverse Events That Are Related to Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sam Browd, MD, PhD | Aqueduct Critical Care, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States | ||
| University of Washington School of Medicine / Harborview Medical Center |
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| ID | Term |
|---|---|
| D006849 | Hydrocephalus |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016543 | Central Nervous System Neoplasms |
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In this study the subject will act as their own control and will be treated on day one with the standard of care EVD and then on Day 2 treated with the SED.
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| Two Days |
| Seattle |
| Washington |
| 98195 |
| United States |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |