Smart External Drain - SED
DeviceSubject 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.
NCT Number: NCT03113799
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.
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Notify Me5 year–80 year
All sexes
Interventional
Not applicable
Seattle Children's Hospital, Seattle, Washington, United States
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Two Days
Average number of staff interactions per patient with standard EVD compared to intervention, the Smart External Drain (SED)
Time frame: Two Days
Total minutes spent by staff interacting with standard EVD compared to SED
Time frame: Two Days
Number of Participants with Adverse Events That Are Related to Treatment
Aqueduct Critical Care
Industry
A Study to Evaluate the Performance and Safety of Aqueduct's Smart External Device (SED) Compared to Standard EVD Drains
Acronym: SED
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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