Pupillometry Use & Professional's Inspection : Leveling Subjectivity (PUPILS)

Comparison of Clinical Pupillary Assessment by Healthcare Professionals With Pupillometry

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.

Study Overview

• Status: Completed
• Conditions: Intensive Care; Interprofessional Relations; Comparative Effectiveness Research; Clinical Competence; Diagnostic Techniques and Procedures; Nursing Assessment; Pupil Assessment; Pupillometry; Neurological Examination; Observer Variation
• Intervention / Treatment: Other: Pupil examination

Detailed Description

This study aims to assess if there is a significant differences in the accuracy and reliability of pupil evaluations between senior physicians, residents, and nurses when compared to the gold standard of pupillometry, an objective and precise measurement technique.

The study will involve a series of assessments where each participant will evaluate patients' pupils under controlled conditions. The results will be compared against the measurements obtained from pupillometry to determine how closely each group aligns with this standard.

By identifying any discrepancies in pupil assessment skills among the different professional groups, we hope to highlight areas for improvement in training and practice. Ultimately, this research aims to enhance patient care by ensuring that pupil evaluations are performed accurately and consistently across all levels of healthcare providers.

The findings from this study could lead to improved training protocols and potentially influence guidelines for pupil assessment in clinical practice, contributing to better patient outcomes in anesthesia and emergency settings.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• France
  • Reims, France
    • Damien JOLLY

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: CHU de Reims

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2025
• Primary Completion (Actual): December 19, 2025
• Study Completion (Actual): December 19, 2025

Study Registration Dates

• First Submitted: December 10, 2024
• First Submitted That Met QC Criteria: December 10, 2024
• First Posted (Actual): December 13, 2024

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: January 9, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Intensive Care; Comparative Effectiveness Research; Diagnostic Techniques and Procedures; Neurological Examination; Pupillometry; Observer Variation; Clinical Competence; Interprofessional Relations; Pupil assessment; Nursing Assessment
• Other Study ID Numbers: PO24112

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No