Pupillometry : Predictive Indicator in External Ventricular Drain Clamping ?

NCT ID: NCT03823430

Last Updated: 2022-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-11

Study Completion Date

2021-03-11

Brief Summary

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Pupillar diameter variation to predict success or failure of external ventricular derivation clamping.

Pupillometry utilisation as a diagnostic tool in external ventricular clamping test in neurological ICU should improve patients care in several ways :

* earlier use of ventriculo-peritoneal or ventriculo-atrial shunts to shorten the external ventricular treatment duration and thus reduce risks of infection and hospital stay duration
* limit the medical imagery prescription and radiation exposition
* avoid neurological deterioration linked to the external ventricular drain clamping in case of the pupillometric parameters variation would be earlier than clinical signs

Detailed Description

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Conditions

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Brain Damage External Ventricular Drain Hydrocephalus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Pupillometry

Pupillar diameter variation measurement

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Neurologic ICU hospitalization
* Traumatic brain injury
* External ventricular drain

Exclusion Criteria

* Legal protection
* refusal
* therapeutics limitation
* craniectomy
* pupillar anomaly
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Association Pro-arte

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Clermont Ferrand

Clermont-Ferrand, , France

Site Status

Chu Grenoble Alpes

Grenoble, , France

Site Status

Countries

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France

Other Identifiers

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3-2018-CLAMP

Identifier Type: -

Identifier Source: org_study_id

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