Frontal Bone Window in ICUF (FBW-ICU) | NCT02832895

Studies
Frontal Bone Window in ICUF (FBW-ICU)

NCT02832895

Sponsor

University Hospital, Montpellier

Status

Terminated

Last Update Posted

Jan 18, 2018Actual

Enrollment

150Actual

Phase

Not Applicable

Conditions

Acute Brain Injury

Interventions

Transcranial doppler examination

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2014-A01436-41	Registry Identifier	ID RCB

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Conducting an interim analysis that allowed with the number of patients included of 150 to meet the objectives of this research

Expanded Access Info

Start Date

Jul 2015

Primary Completion Date

Sep 30, 2016Actual

Completion Date

Dec 30, 2016Actual

First Submitted Date

Jul 12, 2016

First Submission Date that Met QC Criteria

Jul 12, 2016

First Posted Date

Jul 14, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 17, 2018

Last Update Posted Date

Jan 18, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Transcranial doppler (TCD) is an established tool for monitoring flows in intracranial cerebral arteries. Its use is recommanded in the last guidelines on traumatic brain injury. The temporal bone window (TBW) is limited in evaluating flow in the anterior cerebral arteries (ACA) because of an unfavorable insonation angle. Thereby TCD could be unfit to detect a segmental lesion on the anterior cerebral arteries (ACA).

The frontal bone window (FBW) is a promising approach in evaluating flows in the ACA. However, the utility of the FBW for patients with acute brain injury (ABI) in ICU has not been yet determined.

The goal of the present study is to determine the rate of detection of the ACA by using the FBW in patients with ABI in ICU.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Transcranial Doppler examination	Experimental	Transcranial Doppler examination	Other: Transcranial doppler examination

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transcranial doppler examination	Other	Assessment of frontal bone window for transcranial doppler	Transcranial Doppler examination

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
measures of ACA flow velocities threw the frontal bone window		up to 72 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Membership in a health insurance scheme
Patients with an acute cerebral pathology
Hospitalized patients in a supportive care unit of Montpellier University Hospital
Be able to benefit from transcranial doppler within 3 days of admission

Exclusion Criteria:

Clinical suspicion of encephalic death
Known allergy to ultrasound gel

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Camille CM Maury, MD	Montpellier University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Montpellier University Hospital		Montpellier		34295	France

Condition Browse Module

MeSH Terms

ID	Term
D001930	Brain Injuries

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D006259	Craniocerebral Trauma

Browse Leaves

Not provided

Browse Branches

Not provided