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

February 15, 2022 updated by: Association Pro-arte

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France
        • CHU Clermont Ferrand
      • Grenoble, France
        • CHU Grenoble Alpes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 hours after clamping

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Association Pro-arte

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 11, 2018

Primary Completion (ACTUAL)

January 2, 2021

Study Completion (ACTUAL)

March 11, 2021

Study Registration Dates

First Submitted

January 4, 2019

First Submitted That Met QC Criteria

January 29, 2019

First Posted (ACTUAL)

January 30, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 16, 2022

Last Update Submitted That Met QC Criteria

February 15, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3-2018-CLAMP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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