NCT05386303

Brief Summary

The aim of this study is to assess the diagnostic ability of quantitative pupillometry for the early detection of hydrocephalus during the weaning process of the external ventricular drain.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2022

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

May 19, 2021

Completed
1 year until next milestone

First Posted

Study publicly available on registry

May 23, 2022

Completed
8 days until next milestone

Study Start

First participant enrolled

May 31, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

May 23, 2022

Status Verified

May 1, 2021

Enrollment Period

2.3 years

First QC Date

May 19, 2021

Last Update Submit

May 18, 2022

Conditions

HydrocephalusCritical Care

Keywords

PupillometryExternal ventricular drainWeaningBrain injuryPupillary reactivity

Outcome Measures

Primary Outcomes (1)

  • NPi (Neurological Pupil index) and EVD (external ventricular drain)occlusion test

    NPi will be compared between two groups of patients (constituted a posteriori): success and failure of the EVD occlusion test. Independently of this study, the EDV occlusion test starts as soon as prescribed by the physician as a prerequisite before its withdrawal. Failing an occlusion test is defined by the need for reopening the EVD.

    5 days

Secondary Outcomes (8)

  • Diagnostic evaluation

    5 days

  • Pupillometry and EVD occlusion test

    5 days

  • Dilatation velocity

    5 days

  • Maximum constriction velocity

    5 days

  • Latency of contraction

    5 days

  • +3 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult ICU patients with an EVD included at the beginning of the weaning process

You may qualify if:

  • Patient older than 18 years old
  • Admitted to the ICU
  • With an external ventricular drain
  • Consenting to participate (or consent from his/her next of kin, if unable to consent).

You may not qualify if:

  • Patient with pre-existing bilateral pupillary pathology
  • Pregnant or breast-feeding patient
  • Moribund patient or patient with decision of withholding or withdrawing life-sustaining treatment
  • Patient with no health insurance
  • Patient under guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Nantes University Hospital

Nant, Loire-Atlantique, 44093, France

Location

CHU de Nantes

Nantes, 44093, France

Location

MeSH Terms

Conditions

HydrocephalusBrain Injuries

Condition Hierarchy (Ancestors)

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

Study Officials

  • Jérôme DAUVERGNE

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jérôme DAUVERGNE, IDE

CONTACT

33 (0) 2.40.16.52.89jerome.dauvergne@chu-nantes.fr

Study Design

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

Study Record Dates

First Submitted

May 19, 2021

First Posted

May 23, 2022

Study Start

May 31, 2022

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

May 23, 2022

Record last verified: 2021-05

Locations

FR(2)