A Study Evaluate Aqueduct's Smart External Drain

Hydrocephalus Clinical Trial

— SED  

Official title:

A Study to Evaluate the Performance and Safety of Aqueduct's Smart External Device (SED) Compared to Standard EVD Drains

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03113799
• Other study ID #: ASSESSED SED1
• Status: Completed
• Phase: N/A
• Start date: April 12, 2017
• Est. completion date: January 29, 2019

Study information

• Verified date: January 2019
• Source: Aqueduct Critical Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: January 29, 2019
• Est. primary completion date: August 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Hydrocephalus
• Hydrocephalus in Children
• Tumor, Brain

Intervention

Device:
• Smart External Drain - SED
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.

Locations

Country	Name	City	State
United States	Seattle Children's Hospital	Seattle	Washington
United States	University of Washington School of Medicine / Harborview Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Aqueduct Critical Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Staff interactions	Average number of staff interactions per patient with standard EVD compared to intervention, the Smart External Drain (SED)	Two Days
Secondary	Staff Time	Total minutes spent by staff interacting with standard EVD compared to SED	Two Days
Secondary	Safety	Number of Participants with Adverse Events That Are Related to Treatment	Two Days