To evaluate the performance characteristics of the Smart External Drain (SED) compared with standard EVD drains in the hospital setting, specifically: * Number, type and duration of staff interactions. * Regulating and controlling ICP and CSF drainage. * Maintaining system control with patient movement.
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
56
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.
Seattle Children's Hospital
Seattle, Washington, United States
University of Washington School of Medicine / Harborview Medical Center
Seattle, Washington, United States
Staff interactions
Average number of staff interactions per patient with standard EVD compared to intervention, the Smart External Drain (SED)
Time frame: Two Days
Staff Time
Total minutes spent by staff interacting with standard EVD compared to SED
Time frame: Two Days
Safety
Number of Participants with Adverse Events That Are Related to Treatment
Time frame: Two Days
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