Quantitative Pupillometry

Critical Care Clinical Trial

— HYDRO-NiP  

Official title:

Quantitative Pupillometry During External Ventricular Drain Weaning - An Observational Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05386303
• Other study ID #: RC21_0078
• Status: Not yet recruiting
• Start date: May 31, 2022
• Est. completion date: September 1, 2024

Study information

• Verified date: May 2021
• Source: Nantes University Hospital
• Contact: Jérôme DAUVERGNE, IDE
• Phone: 33 (0) 2.40.16.52.89
• Email: jerome.dauvergne[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to assess the diagnostic ability of quantitative pupillometry for the early detection of hydrocephalus during the weaning process of the external ventricular drain.

Description:

Acute hydrocephalus is an emergency often requiring the insertion of an external ventricular drain (EVD). In the aftermath, the patient is transferred to an intensive care unit (ICU) for close monitoring. Ensuring optimal cerebral perfusion through efficient drainage of cerebrospinal fluid while minimizing drainage duration are the objectives of care. Assessing pupillary light reflex is a key test for the detection of neurological deterioration. For long, this assessment has been grossly performed via a qualitative approach (present/absence of pupillary light reflex). For a more precise assessment, quantitative pupillometry has been proposed. Pupil size and constriction speed in response to a standard light are recorded by an automatic portable and user-friendly device. This device is increasingly used in the ICU, mostly for prognostication after acute brain injury. We hypothesized that quantitative pupillometry parameters may vary when hydrocephalus occurs. The aim of this study is to assess whether quantitative pupillometry parameters vary when hydrocephalus occurs. The investigators focused on the early detection of hydrocephalus during the EVD weaning process.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria :

• Patient older than 18 years old
• Admitted to the ICU
• With an external ventricular drain
• Consenting to participate (or consent from his/her next of kin, if unable to consent).

Exclusion Criteria :

• Patient with pre-existing bilateral pupillary pathology
• Pregnant or breast-feeding patient
• Moribund patient or patient with decision of withholding or withdrawing life-sustaining treatment
• Patient with no health insurance
• Patient under guardianship

Related Conditions & MeSH terms

• Critical Care
• Hydrocephalus

Locations

Country	Name	City	State
France	Nantes University Hospital	Nant	Loire-Atlantique
France	CHU de Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NPi (Neurological Pupil index) and EVD (external ventricular drain)occlusion test	NPi will be compared between two groups of patients (constituted a posteriori): success and failure of the EVD occlusion test.; Independently of this study, the EDV occlusion test starts as soon as prescribed by the physician as a prerequisite before its withdrawal.; Failing an occlusion test is defined by the need for reopening the EVD.	5 days
Secondary	Diagnostic evaluation	Pupillometer ability to detect an EDV occlusion test failure will be studied. The area under the ROC curve (AUCROC) will be determined. We define, a priori, that the detection performance will be, respectively, honorable, good or excellent if the AUCROC is higher than 0.70, 0.80 and 0.90.	5 days
Secondary	Pupillometry and EVD occlusion test	Constriction velocity will be compared between two groups of patients (constituted a posteriori): success and failure of the occlusion test.	5 days
Secondary	Dilatation velocity	Dilation velocity will be compared between two groups of patients (constituted a posteriori): success and failure of the occlusion test.	5 days
Secondary	Maximum constriction velocity	Maximum constriction velocity will be compared between two groups of patients (constituted a posteriori): success and failure of the occlusion test.	5 days
Secondary	Latency of contraction	Latency of contraction will be compared between two groups of patients (constituted a posteriori): success and failure of the occlusion test.	5 days
Secondary	Pupil size variation	Pupil size variation will be compared between two groups of patients (constituted a posteriori): success and failure of the occlusion test.	5 days
Secondary	Pupillometry and clinical scores	The association between pupillometry parameters and clinical scores (Glasgow Coma Scale, FOUR score, RASS and CAM-ICU) will be studied	5 days
Secondary	The association between pupillometry parameters and ventricular volume will be studied.	A relationship between, measurements of ventricular volumes (via brain imaging examinations performed regardless of this study) and pupillometry parameters will be sought	5 days