Evaluation of pupillometrY for External Ventricular Drains Stop

All Indication for External Ventricular Drain Clamping Clinical Trial

— EYES  

Official title:

Evaluation of pupillometrY for External Ventricular Drains Stop

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04643717
• Other study ID #: 2018/CHU/01
• Status: Completed
• Start date: November 2, 2018
• Est. completion date: November 2, 2020

Study information

• Verified date: November 2020
• Source: Centre Hospitalier Universitaire de la Réunion
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Placement of an external ventricular shunt is one of the most common neurosurgical procedures in neuro-resuscitation. However, the modalities of its withdrawal are not, the subject of recommendations but rather of service habits. It has been recently demonstrated that pupillary monitoring by an electronic pupillometer was more reliable than standard clinical monitoring in brain injury patients. This tool provides access to a rich pupillary semiology at the patient's bed.

So the goal is to study the evolution of the various pupillary parameters analyzed by the electronic pupillometer during the external ventricular shunt weaning tests and to highlight the predictive factors of failure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: November 2, 2020
• Est. primary completion date: November 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients for whom the doctor orders an external ventricular bypass clamp test

• Neuro-injured patients and non-neuro-injured patients whose state of health requires sedation and mechanical ventilation

Exclusion Criteria:

• Ophthalmological pathology making impossible to carry out measurements by the pupillometer (chemosis, eyelid edema, enucleation, etc.).

• Pregnant woman.

Related Conditions & MeSH terms

• All Indication for External Ventricular Drain Clamping

Intervention

Other:
• Electronic pupillometer analysis
Electronic pupillometer analysis

Locations

Country	Name	City	State
France	Hôpital La Timone	Marseille
France	CHU de la Réunion	Saint-Pierre

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de la Réunion

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference in pupillary contraction speed during the photomotor reflex measured by electronic pupillometer as a function of the outcome of the External ventricular lead clamping test		48 HOURS
Secondary	Comparison of the pupillometry parameters between neuro wronged's patients and not neuro wronged's patients (parameters measured by pupillometer)		48 HOURS