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Pupillometry : Predictive Indicator in External Ventricular Drain Clamping ? (CLAMP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03823430
Recruitment Status : Completed
First Posted : January 30, 2019
Last Update Posted : February 16, 2022
Sponsor:
Information provided by (Responsible Party):
Association Pro-arte

Study Description
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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

Condition or disease Intervention/treatment
Brain Damage External Ventricular Drain Hydrocephalus Diagnostic Test: Pupillometry

Study Design
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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pupillometry : Predictive Indicator in External Ventricular Drain Clamping ?
Actual Study Start Date : July 11, 2018
Actual Primary Completion Date : January 2, 2021
Actual Study Completion Date : March 11, 2021
Groups and Cohorts
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Intervention Details:
  • Diagnostic Test: Pupillometry
    Pupillar diameter variation measurement

Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any patient with an external ventricular drain in neurologic ICU can be recruited in the study if all the eligibility criteria are met.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Legal protection
  • refusal
  • therapeutics limitation
  • craniectomy
  • pupillar anomaly
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03823430


Locations
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France
CHU Clermont Ferrand
Clermont-Ferrand, France
Chu Grenoble Alpes
Grenoble, France
Sponsors and Collaborators
Association Pro-arte
More Information
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Responsible Party: Association Pro-arte
ClinicalTrials.gov Identifier: NCT03823430    
Other Study ID Numbers: 3-2018-CLAMP
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: February 16, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hydrocephalus
Brain Injuries
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries