Intensive CarePUPILSNCT06733207
Pupillometry Use & Professional's Inspection : Leveling Subjectivity
An observational study of Intensive Care and Pupil Assessment, run by CHU de Reims at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care, Pupil Assessment, Pupillometry
- What is being tested?
- Pupil examination
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 17 Feb 2025to 19 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- Aged under 18 years
- Undergoing ocular surgery
- Unable to evaluate both pupils
- Not affiliated with a social security scheme
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Intensive Care, Pupil Assessment, Pupillometry, Neurological Examination, Clinical Competence, Nursing Assessment
- Being tested
- Pupil examination
- Keywords
- Intensive Care, Pupil assessment, Pupillometry, Neurological Examination, Clinical Competence, Nursing Assessment, Diagnostic Techniques and Procedures, Comparative Effectiveness Research, Interprofessional Relations, Observer Variation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pupil examinationOther
Pupil assessment : bilateral clinical examination of the patient's pupils, assessed in qualitative data : mydriasis, myosis, pupillary light reflex, anisocoria or isochoria.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Pupil examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start17 Feb 2025
- Primary completion19 Dec 2025
- Study completion19 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intensive CareStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06733207
- Sponsor's protocol ID
- PO24112
- Acronym
- PUPILS
- Status last verified
- Jan 2026
- First submitted
- 10 Dec 2024
- Last updated
- 12 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Arndt A, Seube-Remy PA, Floch T, Arndt C, Kanagaratnam L, Legros V. Comparison of bedside clinical pupillary assessment with automated pupillometry in sedated ICU patients. BMC Anesthesiol. 2026 Jul 28;26(1):647. doi: 10.1186/s12871-026-04124-z.
PubMed 42968011
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Clinical Pupillary Assessment by Healthcare Professionals With Pupillometry
- ClinicalTrials.gov ID
- NCT06733207
- Acronym / sponsor ID
- PUPILS / PO24112
- Conditions
- Intensive Care, Pupil Assessment, Pupillometry, Neurological Examination, Clinical Competence, Nursing Assessment
- Keywords
- Intensive Care, Pupil assessment, Pupillometry, Neurological Examination, Clinical Competence, Nursing Assessment, Diagnostic Techniques and Procedures, Comparative Effectiveness Research
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- 19 Dec 2025 (actual)
- Study completion
- 19 Dec 2025 (actual)
- First posted
- 13 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients in Intensive Care | – | Other: Pupil examinationThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- Aged under 18 years
- Undergoing ocular surgery
- Unable to evaluate both pupils
- Not affiliated with a social security scheme
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pupil examinationPupil assessment : bilateral clinical examination of the patient's pupils, assessed in qualitative data : mydriasis, myosis, pupillary light reflex, anisocoria or isochoria. | Other | Patients in Intensive Care |
Primary outcome
pupil examination
Time frame: Day 1
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Derived from this study: PubMed 42968011Arndt A, Seube-Remy PA, Floch T, Arndt C, Kanagaratnam L, Legros V. Comparison of bedside clinical pupillary assessment with automated pupillometry in sedated ICU patients. BMC Anesthesiol. 2026 Jul 28;26(1):647. doi: 10.1186/s12871-026-04124-z.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intensive Care and Pupil Assessment, run by CHU de Reims at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pupil examination (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06733207, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.