Pupillometry : Predictive Indicator in External Ventricular Drain Clamping ?

Completed

• Conditions: Brain Damage; External Ventricular Drain; Hydrocephalus

• Registration Number: NCT03823430
• Lead Sponsor: Association Pro-arte

Brief Summary

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

Not available

Study Timeline

• Study Start: 2018-07-11
• Study First Submitted: 2019-01-04
• Study First Submitted QC: 2019-01-29
• Study First Posted: 2019-01-30
• Primary Completion: 2021-01-02
• Study Completion: 2021-03-11
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-15
• Last Update Posted: 2022-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

• Legal protection
• refusal
• therapeutics limitation
• craniectomy
• pupillar anomaly

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pupillar diameter variation to predict success or failure of external ventricular clamping	24 hours after clamping	Pupillar diameter variation twenty-four hours after external ventricular drain clamping

Trial Locations

Locations (2)

CHU Clermont Ferrand; 🇫🇷 Clermont-Ferrand, France

Chu Grenoble Alpes; 🇫🇷 Grenoble, France