NCT03823430

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2018

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 11, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2019

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 30, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2021

Completed
Last Updated

February 16, 2022

Status Verified

February 1, 2022

Enrollment Period

2.5 years

First QC Date

January 4, 2019

Last Update Submit

February 15, 2022

Conditions

Brain DamageExternal Ventricular DrainHydrocephalus

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

PupillometryDIAGNOSTIC_TEST

Pupillar diameter variation measurement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU Clermont Ferrand

Clermont-Ferrand, France

Location

Chu Grenoble Alpes

Grenoble, France

Location

MeSH Terms

Conditions

Brain InjuriesHydrocephalus

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2019

First Posted

January 30, 2019

Study Start

July 11, 2018

Primary Completion

January 2, 2021

Study Completion

March 11, 2021

Last Updated

February 16, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)