NCT06733207

Brief Summary

This prospective, non interventionneal, mono-centric study aims to evaluate the accuracy and quality of pupil assessment among three different groups: senior physicians, anesthesiology residents, and nurses. Pupil assessment is a critical component in anesthesia and emergency medicine, providing essential information about a patient's neurological status and response to medications.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 13, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

February 17, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2025

Completed
Last Updated

January 12, 2026

Status Verified

January 1, 2026

Enrollment Period

10 months

First QC Date

December 10, 2024

Last Update Submit

January 9, 2026

Conditions

Keywords

Intensive CarePupil assessmentPupillometryNeurological ExaminationClinical CompetenceNursing AssessmentDiagnostic Techniques and ProceduresComparative Effectiveness ResearchInterprofessional RelationsObserver Variation

Outcome Measures

Primary Outcomes (1)

  • pupil examination

    comparison of pupil examination through an intraclass correlation coefficient for each category of healthcare professional to measure the concordance between the subjective pupillary examination and pupillometry

    Day 1

Study Arms (1)

Patients in Intensive Care

This prospective diagnostic study involves a single cohort of patients undergoing pupil assessment. Within this cohort, the evaluations will be performed by three distinct sub-cohorts of healthcare providers: * Senior physicians : Experienced anesthesiologists or critical care specialists with extensive training in pupil evaluation and neurological assessment. * Anesthesiology Residents: Trainees responsible for assessing the pupils of the patients, focusing on their developing assessment skills. * Nurses: Registered nurses involved in the assessment of patients' pupils as part of their routine care.

Other: Pupil examination

Interventions

Pupil assessment : bilateral clinical examination of the patient's pupils, assessed in qualitative data : mydriasis, myosis, pupillary light reflex, anisocoria or isochoria.

Patients in Intensive Care

Eligibility Criteria

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

Adults hospitalized in the Surgical Intensive Care Unit at CHU de Reims who have consented to participate in the study, or for whom a designated trusted person has provided consent for their participation

You may qualify if:

  • Hospitalized in Intensive Care
  • Patients who gave their consent to participate to the study, or, if incapable of giving their consent, for whom their designated trusted person has provided their consent.

You may not qualify if:

  • Aged under 18 years
  • Undergoing ocular surgery
  • Unable to evaluate both pupils
  • Not affiliated with a social security scheme

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Damien JOLLY

Reims, France

Location

Study Design

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

Study Record Dates

First Submitted

December 10, 2024

First Posted

December 13, 2024

Study Start

February 17, 2025

Primary Completion

December 19, 2025

Study Completion

December 19, 2025

Last Updated

January 12, 2026

Record last verified: 2026-01

Locations