NCT01685476

Brief Summary

In clinical practice, intracranial pressure (ICP) represents a key parameter for diagnosing and treating several conditions. Physicians having to manage cases of head trauma, stroke and hydrocephalus need to assess the time course of ICP, yet they are often unwilling to implement invasive monitoring beyond the acute stage, on account of high septic risks. Standard techniques include direct ventricular manometry or measurement in the parenchyma with electronic or fiberoptic devices. Therefore, the design of non-invasive clinical methods for gaining access to pressure changes is an important challenge. Fluctuations of ICP are transmitted to the fluid spaces of the inner ear through the cochlear aqueduct. The Biophysics Laboratory (School of Medicine of Clermont-Ferrand) described that the intra-labyrinthic pressure modify the functional activities of the outer hair cells in the cochlea. Thereby, increases in ICP are transferred to increases in intra-cochlear pressure, which is detected as modifications in cochlear activities. Cochlear activities' recording are non-invasive and technically simple. A probe is gently inserted into the outer portion of the external ear canal. The objective of this study is to assess prospectively the accuracy and the precision of a new method for ICP monitoring (using cochlear activities) compared with invasive gold standard CSF pressure monitoring.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2011

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

January 1, 2011

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 14, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

July 8, 2014

Status Verified

July 1, 2014

Enrollment Period

1.8 years

First QC Date

August 31, 2012

Last Update Submit

July 4, 2014

Conditions

Intracranial PressureTraumatic Brain InjuryStrokeIntracranial Hemorrhages

Keywords

Cochlear microphonic potentialnon invasive methodindirect monitoringintracranial pressure

Outcome Measures

Primary Outcomes (1)

  • Cochlear Microphonic Potential phase shift

    acquisition every 5minutes during 4hours

Secondary Outcomes (1)

  • IntraCranialPressure variations

    every minutes during 4 hours

Study Arms (1)

Intracranial pressure

OTHER
Device: Echodia® hand-held equipment

Interventions

Echodia® hand-held equipmentDEVICE
Intracranial pressure

Eligibility Criteria

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

You may qualify if:

  • Patients with intracranial pressure monitoring
  • Age greater than 18
  • consent form signed by a close relative (husband, wife, children, legal guardian),
  • Patient covered under French social security or being a beneficiary of such a regime under the terms of the Act of August 9, 2004

You may not qualify if:

  • Refusal by the close relative to sign a consent form
  • Impossibility of electrophysiological measurements (pathophysiological reason)
  • Technical troubles with the device
  • Patient uncovered under French social security

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Clermont Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (1)

  • Giraudet F, Longeras F, Mulliez A, Thalamy A, Pereira B, Avan P, Sakka L. Noninvasive detection of alarming intracranial pressure changes by auditory monitoring in early management of brain injury: a prospective invasive versus noninvasive study. Crit Care. 2017 Feb 21;21(1):35. doi: 10.1186/s13054-017-1616-2.

    PMID: 28219399DERIVED

MeSH Terms

Conditions

Brain Injuries, TraumaticStrokeIntracranial Hemorrhages

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesCerebrovascular DisordersVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Laurent SAKKA

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2012

First Posted

September 14, 2012

Study Start

January 1, 2011

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

July 8, 2014

Record last verified: 2014-07

Locations

FR(1)