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OpenTrials
Completed

NCT Number: NCT03823430

Pupillometry : Predictive Indicator in External Ventricular Drain Clamping ?

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Clermont Ferrand, Clermont-Ferrand, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Pupillometry

Diagnostic Test

Pupillar diameter variation measurement

Primary outcomes

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

    Time frame: 24 hours after clamping

    Pupillar diameter variation twenty-four hours after external ventricular drain clamping

Sponsors and collaborators

Lead sponsor

Association Pro-arte

Other

Registry information

Acronym: CLAMP

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jan 30, 2019
Registry last updated
Feb 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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