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NCT03823430 Clinical Trial

Pupillometry : Predictive Indicator in External Ventricular Drain Clamping ?

Hydrocephalus Clinical Trial

— CLAMP  

Official title:
Pupillometry : Predictive Indicator in External Ventricular Drain Clamping ?

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03823430
Other study ID # 3-2018-CLAMP
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 11, 2018
Est. completion date March 11, 2021

Study information
Verified date February 2022
Source Association Pro-arte
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date March 11, 2021
Est. primary completion date January 2, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Neurologic ICU hospitalization - Traumatic brain injury - External ventricular drain Exclusion Criteria: - Legal protection - refusal - therapeutics limitation - craniectomy - pupillar anomaly

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Pupillometry
Pupillar diameter variation measurement

Locations
Country Name City State
France CHU Clermont Ferrand Clermont-Ferrand
France Chu Grenoble Alpes Grenoble

Sponsors (1)
Lead Sponsor Collaborator
Association Pro-arte

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pupillar diameter variation to predict success or failure of external ventricular clamping Pupillar diameter variation twenty-four hours after external ventricular drain clamping 24 hours after clamping
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