NCT02695264

Brief Summary

The purpose of this study is to prospectively evaluate the accuracy and safety of non-invasive intracranial pressure (ICP) measurements using the HeadSense-1000 (HS-1000) device compared to the current invasive external ventricular device (EVD) or parenchymal (bolt) monitoring devices in the pediatric population.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 1, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 23, 2016

Status Verified

December 1, 2016

Enrollment Period

4 months

First QC Date

February 22, 2016

Last Update Submit

December 21, 2016

Conditions

Intracranial Hypertension

Keywords

intracranial pressureintracranial hypertensionsevere traumatic brain injury

Outcome Measures

Primary Outcomes (1)

  • ICP recordings from the HS-1000 device compared to those from the invasive ICP monitor

    5 days of bolt insertion or 10 days of EVD insertion

Secondary Outcomes (1)

  • Safety of the HS-1000 as determined by number of reported device-related adverse events

    Up to 48hours after last recording

Study Arms (1)

HS-1000 recording

EXPERIMENTAL

ICP readings will be recorded from both the invasive and HeadSense non-invasive ICP monitor for an aggregate of 30 minutes. During the recording sessions, a webcam will take periodic snapshots of the ICP monitor and/or bedside monitor picturing the ICP values and other clinical parameters that are displayed on screen, with a focus on blood pressure and heart rate (HR). Recording sessions will be done until an aggregate of at least 30 minutes of data are collected, depending on the patient's clinical condition. Recording sessions may be repeated over several days until the 30 minute target is reached.

Device: HS-1000 recording

Interventions

HS-1000 recordingDEVICE
HS-1000 recording

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Males and females \<= 18 years old admitted to the PICU whose treatment includes a surgical ICP monitor.
  • Subject or legal authorized representative (per local regulation) is able and willing to comply with the requirements of the protocol
  • Subject or legal authorized representative (per local regulation) is able to understand and sign written informed consent to participate in the study

You may not qualify if:

  • Subject with an invasive ICP monitor placed Ten (10) days or before the date of recording for EVD monitor OR Five (5) days or before the date of recording for Bolt monitor
  • Subjects with more than one invasive ICP monitor in place at the time of recording
  • Ear disease/ear trauma
  • Subjects with severe head trauma in which the location and/or severity of the skull fracture(s), i.e. frank skull fracture or major joint dislocations with parenchyma exposed to room pressure, may jeopardize HeadSense monitoring procedure \[Post-craniotomy patients with intact dura and accurate ICP values from the invasive EVD are eligible.\]
  • Severe TBI that jeopardizes HS-1000 monitoring procedure
  • Cerebral spinal fluid (CSF) otorrhea
  • Allergy/Hypersensitivity to test materials
  • Pregnant or breast feeding
  • Current enrollment (or within 30 days) in another investigational device or drug study, OR receiving an investigational agent
  • Any condition that jeopardizes study participation (abnormal clinical/lab finding)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akron Children's Hospital

Akron, Ohio, 44308, United States

Location

MeSH Terms

Conditions

Intracranial HypertensionBrain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesBrain InjuriesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Michael L Forbes, MD

    Akron Children's Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2016

First Posted

March 1, 2016

Study Start

August 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

December 23, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)