Non-invasive Intracranial Pressure (ICP) Monitoring in Pediatric Patients
Withdrawn before enrolling · Not applicable
Conditions studied: Intracranial Hypertension
In brief
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.
Key facts
- Study ID
- NCT02695264
- Run by
- HeadSense Medical
- People needed
- 0
- Starts
- 2016-08-01
- Expected to finish
- 2016-12-01
- Last updated by the study team
- 2016-12-23
Who can join
Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.
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)
Where it is running
- Akron Children's Hospital — Akron, Ohio, United States
Full record on ClinicalTrials.gov
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