A Study Evaluate Aqueduct's Smart External Drain (NCT03113799) | Clinical Trial Compass
CompletedNot Applicable
A Study Evaluate Aqueduct's Smart External Drain
United States56 participantsStarted 2017-04-12
Plain-language summary
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.
Who can participate
Age range5 Years ā 80 Years
SexALL
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Inclusion criteria
ā. Stable Neuro - examination on standard EVD assessed as Not Clinically Significant (NCS) by PI or delegated Sub-I prior to study treatment.
ā. GCS \> 13 (minimum of E3V5M5) prior to study treatment.
ā. Subject must be scheduled to have an EVD placed as part of routine management and for a length of at least 48 hours. (e.g. in the setting of a tumor removal or treatment of hydrocephalus)
ā. Age 5-80.
ā. Stable Vital Signs - Blood pressure (Systolic and Diastolic), Heart Rate, Respiratory Rate and weight assessed as not clinically significant (NCS) and afebrile as per PI/Sub-assessment. (Stable Vital signs will be re-assessed again prior to treatment with the SED on Day 2)
ā. Able to perform and follow simple commands (ex: sit up in bed, lay down in bed)
ā. Pre-Study CT/MRI Imaging stable per PI Sub-I Assessment post ventriculostomy.
ā. Able to stand
Exclusion criteria
ā. Refractory ICP or needing active ICP management
ā. Unable to tolerate brief clamping of EVD (\<5min)