A Study Evaluate Aqueduct's Smart External Drain

Completed · Not applicable

Conditions studied: Hydrocephalus, Hydrocephalus in Children, Tumor, Brain

In brief

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.

Key facts

Study ID

NCT03113799

Run by

Aqueduct Critical Care

People needed

56

Starts

2017-04-12

Expected to finish

2019-01-29

Last updated by the study team

2019-01-31

Who can join

Age: 5 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Stable Neuro - examination on standard EVD assessed as Not Clinically Significant (NCS) by PI or delegated Sub-I prior to study treatment.
• GCS > 13 (minimum of E3V5M5) prior to study treatment.
• 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)
• Age 5-80.
• 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)
• Able to perform and follow simple commands (ex: sit up in bed, lay down in bed)
• Pre-Study CT/MRI Imaging stable per PI Sub-I Assessment post ventriculostomy.
• Able to stand
• Able to obtain consent

You may not qualify if…

• Refractory ICP or needing active ICP management
• Unable to tolerate brief clamping of EVD (<5min)
• Unable to follow simple commands
• Unconscious
• Anticoagulant Therapy
• Known bleeding diathesis
• Scalp Infection
• In the opinion of the Investigator the subject is not a good study candidate

Where it is running

• Seattle Children's Hospital — Seattle, Washington, United States
• University of Washington School of Medicine / Harborview Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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