Hydrocephalus, Hydrocephalus in Children, Tumor, Brain
Conditions
Brief 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.
Detailed description
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
Interventions
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.
Sponsors
Aqueduct Critical Care
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
5 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Stable Neuro - examination on standard EVD assessed as Not Clinically Significant (NCS) by PI or delegated Sub-I prior to study treatment. 2. GCS \> 13 (minimum of E3V5M5) prior to study treatment. 3. 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) 4. Age 5-80. 5. 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) 6. Able to perform and follow simple commands (ex: sit up in bed, lay down in bed) 7. Pre-Study CT/MRI Imaging stable per PI Sub-I Assessment post ventriculostomy. 8. Able to stand 9. Able to obtain consent
Exclusion criteria
1. Refractory ICP or needing active ICP management 2. Unable to tolerate brief clamping of EVD (\<5min) 3. Unable to follow simple commands 4. Unconscious 5. Anticoagulant Therapy 6. Known bleeding diathesis 7. Scalp Infection 8. In the opinion of the Investigator the subject is not a good study candidate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Staff interactions | Two Days | Average number of staff interactions per patient with standard EVD compared to intervention, the Smart External Drain (SED) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Staff Time | Two Days | Total minutes spent by staff interacting with standard EVD compared to SED |
| Safety | Two Days | Number of Participants with Adverse Events That Are Related to Treatment |
Countries
United States
Outcome results
None listed