A Study Evaluate Aqueduct's Smart External Drain

NCT ID: NCT03113799

Last Updated: 2019-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-12
• Study Completion Date: 2019-01-29

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

Conditions

Hydrocephalus; Hydrocephalus in Children; Tumor, Brain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single Arm study

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).

Group Type: OTHER

Smart External Drain - SED

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aqueduct Critical Care

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sam Browd, MD, PhD

Role: STUDY_DIRECTOR

Aqueduct Critical Care, Inc

Locations

Seattle Children's Hospital

Seattle, Washington, United States

University of Washington School of Medicine / Harborview Medical Center

Seattle, Washington, United States

Countries

United States

Other Identifiers

ASSESSED SED1

Identifier Type: -

Identifier Source: org_study_id