Hydrocephalus, Hydrocephalus in Children, Subarachnoid Hemorrhage, Tumor, Brain
Conditions
Brief summary
Aqueduct's Smart External Drain (SED) will be compared to the current gold standard for temporary CSF management in a hospital setting. * Evaluate the number of subjects requiring to be switched to a standard of care EVD * Evaluate subject transport while on the SED * Evaluate SED system control from initiation of SED through discharge of external drain system
Detailed description
This clinical trial will evaluate Aqueduct's Smart External Drain (SED) upon implementation of ventriculostomy or lumbar drain placement for temporary CSF external management in a hospital setting. Subjects will remain on study from the time of SED application through discharge of the external drain or switch to standard of care extraventricular drain.
Interventions
Aqueduct's Smart External Drain (SED) is a gravity based system which utilizes a proprietary reference shroud which eliminates the need for manual adjustment of the system in the external management of CSF drainage.
Sponsors
Aqueduct Critical Care
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Subject scheduled to have an external drain (includes extra-ventricular and lumbar drains) placed as part of routine management. 2. Age 0-80. 3. Able to obtain consent or legally authorized representative (LAR) consents for subject to be treated on study.
Exclusion criteria
1. Anticoagulant therapy (does not include DVT or PE prophylaxis). 2. Known bleeding diathesis. 3. Scalp infection. 4. In the opinion of the Investigator the subject is not a good study candidate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The number of subjects which require switching to a standard of care external drain. | The study review and data collection period will begin at the time SED is connected to the ventriculostomy catheter until discharge of ventriculostomy catheter; when subject no longer requires an external drain, assessed up to 90 days. | Evaluating the number of subjects which require switching to a standard of care external drain versus the number of subjects which remain on the SED until study completion or discharge of the external drain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject transport while on the SED system. | Subject transport review and data collection will begin when the patient is moved from their primary hospital bed location until they reach a new secondary location or are returned to the primary location. Assessed up to 90 days. | Evaluating subject transport while on the SED system, specifically, the number of minutes a subject will require clamping of the drain while being transported. |
| Evaluating SED system control throughout duration of study. | The study review and data collection period will begin at the time SED is connected to the ventriculostomy catheter until discharge of ventriculostomy catheter; when subject no longer requires an external drain, assessed up to 90 days. | SED system control will be evaluated from initiation of ICP management through discharge of the subject's external drain. |
Countries
United States
Outcome results
None listed