A Study Evaluate Aqueduct's Smart External Drain (SED)

Aqueduct Critical Care

Status: Completed

Conditions: Hydrocephalus; Hydrocephalus in Children; Tumor, Brain

Treatments: Device: Smart External Drain - SED

Study type: Interventional

Funder types: Industry

Identifiers

NCT03113799

ASSESSED SED1

Details and patient eligibility

About

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.

Full 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

Enrollment: 56 patients

Sex: All

Ages: 5 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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56 participants in 1 patient group

Single Arm study

Other group

Description:

Single Arm study In this study, the subject will act as their own control. On Day 1 of the two day study, the subject will be observed while treated on their standard EVD. On Day 2, the subject will be treated with the Smart External Drain (SED).

Treatment:

Device: Smart External Drain - SED