A Study Evaluate Aqueduct's Smart External Drain

Not Applicable

Completed

• Conditions: Hydrocephalus in Children; Tumor, Brain; Hydrocephalus
• Interventions: Device: Smart External Drain - SED

• Registration Number: NCT03113799
• Lead Sponsor: Aqueduct Critical Care

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

Study Timeline

• Study First Submitted: 2017-03-20
• Study First Submitted QC: 2017-04-10
• Study Start: 2017-04-12
• Study First Posted: 2017-04-14
• Primary Completion: 2018-08-15
• Status Verified: 2019-01
• Study Completion: 2019-01-29
• Last Update Submitted: 2019-01-29
• Last Update Posted: 2019-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm study	Smart External Drain - SED	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).

Primary Outcome Measures

Name	Time	Method
Staff interactions	Two Days	Average number of staff interactions per patient with standard EVD compared to intervention, the Smart External Drain (SED)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Seattle Children's Hospital; 🇺🇸 Seattle, Washington, United States

University of Washington School of Medicine / Harborview Medical Center; 🇺🇸 Seattle, Washington, United States