NCT02773862

Brief Summary

Patients with severe traumatic brain injury (TBI) are admitted to the intensive care unit (ICU). Under certain condition (such as a impaired consciousness) the intracranial pressure (ICP) is measured. An increase in the intracranial pressure might suggest secondary neurological deterioration and is considered an alarming symptom. Current practice is to insert an invasive monitor through a burr hole in the skull with the risk of bleeding and infection. Using a new type of ICP monitor (HeadSense) it is possible to measure ICP non-invasively through an acoustic signal.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 16, 2016

Completed
Last Updated

May 17, 2016

Status Verified

May 1, 2016

Enrollment Period

1.3 years

First QC Date

May 12, 2016

Last Update Submit

May 13, 2016

Conditions

Brain InjuriesIntracranial Hypertension

Keywords

brain injuriesnoninvasive monitoringintracranial pressure

Outcome Measures

Primary Outcomes (1)

  • Number of ICP values obtained by the HS device that correlate to ICP using current standards

    30 minutes

Study Arms (1)

HS-1000 recording

EXPERIMENTAL

ICP monitoring will be done in parallel for both HS-1000 and ICP monitoring via an invasive monitoring device (per clinical protocol without any change in the patient's management). HS-1000 ICP monitoring intervals will last from 30 minutes to 48 hours, continuously depending on the patient's clinical condition.

Device: HS-1000

Interventions

HS-1000DEVICE
HS-1000 recording

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have an invasive ICP monitoring
  • Male or Female in the age range of 18 years and older

You may not qualify if:

  • Local infection in the ear.
  • Pregnant/lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Elisabeth Ziekenhuis

Tilburg, Netherlands

Location

MeSH Terms

Conditions

Brain InjuriesIntracranial Hypertension

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Guus Schoonman, MD, PhD

    St. Elisabeth/Tweesteden Hospital Tilburg

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 12, 2016

First Posted

May 16, 2016

Study Start

June 1, 2014

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

May 17, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)