Critical IllnessPUPILNCT07616518
Dynamic Trajectories of Pupillary Light Reflex Parameters and Prognosis in Critically Ill Patients: A Multicenter Prospective Cohort Study
An observational study of Critical Illness and Pupillometry, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
This multicenter prospective observational cohort study aims to investigate the association between early dynamic trajectories of pupillary light reflex parameters and clinical outcomes in critically ill patients admitted to emergency intensive care units. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Pupillometry, Prognosis
- How many people
- 700 participants
- Where
- No sites listed yet
- Study dates
- 6 Jun 2026to 13 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Adult critically ill patients admitted to emergency intensive care units at participating tertiary hospitals will be screened for eligibility. Eligible patients are those expected to stay in the EICU for more than 48 hours and for whom reliable quantitative pupillometry can be performed. Written informed consent will be obtained from the participant or a legally authorized representative before enrollment.
Who may be able to join
- Age 18 years or older.
- Admission to the emergency intensive care unit.
- Critically ill patients with an expected EICU stay longer than 48 hours.
- Written informed consent obtained from the participant or legally authorized representative.
Who cannot join
- Severe ocular disease, severe ocular trauma, postoperative ocular status, or other conditions that prevent reliable pupillary measurement.
- Known neuro-ophthalmic disorders that may affect the pupillary light reflex, such as oculomotor nerve palsy.
- Use of topical ophthalmic medications during the study period that may significantly affect pupillary response, when their effects cannot be accurately recorded or evaluated.
- Pregnancy or breastfeeding.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This multicenter prospective observational cohort study aims to investigate the association between early dynamic trajectories of pupillary light reflex parameters and clinical outcomes in critically ill patients admitted to emergency intensive care units. Quantitative pupillometry will be performed during the first 7 days after EICU admission. Constriction velocity will be the primary parameter for trajectory analysis, while dilation velocity, pupil diameter, constriction percentage, maximum constriction velocity, and latency will be analyzed as supplementary parameters. The study will evaluate whether these dynamic pupillary trajectories are associated with discharge outcome and 90-day functional outcome assessed by the Glasgow Outcome Scale-Extended.
Read the detailed description
Critically ill patients admitted to emergency intensive care units often have complex underlying conditions, rapid changes in disease severity, fluctuating organ function, and multiple therapeutic influences. Conventional assessment tools, including vital signs, Glasgow Coma Scale, RASS, CPOT, APACHE II, laboratory tests, and imaging examinations, are important in clinical practice but may be limited by subjectivity, intermittent availability, or reduced reliability in patients receiving sedation, analgesia, mechanical ventilation, or organ support.
The pupillary light reflex is a classic component of neurological examination. Automated quantitative pupillometry provides objective and reproducible measurements of pupillary light reflex parameters, including pupil diameter, constriction velocity, dilation velocity, constriction percentage, maximum constriction velocity, and latency. These parameters may reflect brainstem reflex function, autonomic nervous system activity, medication effects, pain, circulatory status, and systemic stress responses in critically ill patients.
This study will enroll adult critically ill patients admitted to participating emergency intensive care units. After written informed consent is obtained from the participant or a legally authorized representative, baseline demographic data, primary diagnosis, disease severity scores, treatment information, organ support, sedation and analgesia status, vasoactive medication use, and vital signs will be collected. Pupillary light reflex parameters will be measured using a handheld automated quantitative pupillometer once daily during the first 7 days after EICU admission, or until EICU discharge or death, whichever occurs first. Additional measurements may be performed when clinically indicated.
The primary analysis will focus on the dynamic trajectory of constriction velocity during the early EICU period. Dilation velocity, pupil diameter, constriction percentage, maximum constriction velocity, and latency will be analyzed as supplementary pupillary light reflex parameters. Group-based trajectory modeling will be used to identify distinct longitudinal trajectory patterns of pupillary light reflex parameters.
The primary outcome is 90-day functional outcome assessed by the Glasgow Outcome Scale-Extended. Unfavorable functional outcome is defined as a GOS-E score of 4 or lower, and death during follow-up will be included in the GOS-E scoring system. The secondary outcome is discharge outcome, which will be analyzed primarily as a binary outcome. Favorable discharge outcome is defined as discharge home or transfer to a rehabilitation facility. Unfavorable discharge outcome is defined as in-hospital death, discharge to hospice or long-term care facility, or discharge against medical advice. Transfer to a higher-level hospital or another medical institution for continued treatment will be recorded as an indeterminate disposition and further followed when feasible.
This study will further evaluate whether dynamic trajectories of pupillary light reflex parameters provide additional prognostic value beyond conventional static measurements and clinical variables. No treatment assignment or intervention will be performed as part of this study. All clinical management decisions will be made by the treating physicians according to routine clinical practice.
- Conditions
- Critical Illness, Pupillometry, Prognosis
- Keywords
- Pupillary light reflex, Critically ill patients, Dynamic trajectory, Prognosis, Constriction Velocity
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adult critically ill patients admitted to the EICU | Adult critically ill patients admitted to emergency intensive care units who meet the eligibility criteria will be enrolled in a single prospective observational cohort. Participants will undergo quantitative pupillometry during the first 7 days after EICU admission, or until EICU discharge or death, whichever occurs first. Clinical information, treatment data, discharge outcome, and 90-day functional outcome will be collected. |
What is being measured
The primary outcome is the main question the study is designed to answer.
90-Day Functional Outcome Assessed by the Glasgow Outcome Scale-Extended
Functional outcome will be assessed using the Glasgow Outcome Scale-Extended at 90 days after disease onset. Unfavorable functional outcome is defined as a GOS-E score of 4 or lower. Participants who die during follow-up will be included in the GOS-E scoring system, and the 90-day mortality rate will be reported separately.
Measured: 90 days after disease onset
Secondary outcomes (1)
Discharge Outcome
Discharge outcome will be analyzed primarily as a binary outcome: favorable versus unfavorable discharge outcome. Favorable discharge outcome is defined as discharge home or transfer to a rehabilitation facility. Unfavorable discharge outcome is defined as in-hospital death, discharge to hospice, transfer to a long-term care facility, or discharge against medical advice. Transfer to a higher-level hospital or another medical institution for continued treatment will be recorded as an indeterminate disposition and further followed when feasible.
Measured: From EICU admission to hospital discharge; indeterminate transfers will be followed up to 90 days when feasible
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start6 Jun 2026 (estimated)
- Primary completion13 Oct 2026 (estimated)
- Study completion13 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- 700 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang Provincial People's Hospital, Zhejiang Provincial Tongde Hospital, Jinhua Municipal Central Hospital, Huzhou Central Hospital, Lishui Country People's Hospital, Lishui Municipal Central Hospital, Ningbo Medical Center Lihuili Hospital, The Second Affiliated Hospital of Jiaxing University, The Fourth Affiliated Hospital of Zhejiang University School of Medicine, The Third Affiliated Hospital of Wenzhou Medical University, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, People's Hospital of Quzhou, First People's Hospital of Hangzhou
- Responsible party
- Sponsor
- Investigators
- Mao Zhang, MD, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07616518
- Sponsor's protocol ID
- 20260245
- Acronym
- PUPIL
- Status last verified
- May 2026
- First submitted
- 24 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study involves sensitive clinical data from critically ill patients and data sharing is not currently covered by the informed consent or ethics approval. De-identified aggregate results will be reported in publications.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Trajectories of Pupillary Light Reflex Parameters and Prognosis in Critically Ill Patients: A Multicenter Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07616518
- Acronym / sponsor ID
- PUPIL / 20260245
- Conditions
- Critical Illness, Pupillometry, Prognosis
- Keywords
- Pupillary light reflex, Critically ill patients, Dynamic trajectory, Prognosis, Constriction Velocity
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Zhejiang Provincial People's Hospital, Zhejiang Provincial Tongde Hospital, Jinhua Municipal Central Hospital, Huzhou Central Hospital, Lishui Country People's Hospital, Lishui Municipal Central Hospital, Ningbo Medical Center Lihuili Hospital, The Second Affiliated Hospital of Jiaxing University, The Fourth Affiliated Hospital of Zhejiang University School of Medicine, The Third Affiliated Hospital of Wenzhou Medical University, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, People's Hospital of Quzhou, First People's Hospital of Hangzhou
- Study start
- 6 Jun 2026 (estimated)
- Primary completion
- 13 Oct 2026 (estimated)
- Study completion
- 13 Oct 2026 (estimated)
- First posted
- 1 Jun 2026 (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 multicenter prospective observational cohort study aims to investigate the association between early dynamic trajectories of pupillary light reflex parameters and clinical outcomes in critically ill patients admitted to emergency intensive care units. Quantitative pupillometry will be performed during the first 7 days after EICU admission. Constriction velocity will be the primary parameter for trajectory analysis, while dilation velocity, pupil diameter, constriction percentage, maximum constriction velocity, and latency will be analyzed as supplementary parameters. The study will evaluate whether these dynamic pupillary trajectories are associated with discharge outcome and 90-day functional outcome assessed by the Glasgow Outcome Scale-Extended.
Detailed description
Critically ill patients admitted to emergency intensive care units often have complex underlying conditions, rapid changes in disease severity, fluctuating organ function, and multiple therapeutic influences. Conventional assessment tools, including vital signs, Glasgow Coma Scale, RASS, CPOT, APACHE II, laboratory tests, and imaging examinations, are important in clinical practice but may be limited by subjectivity, intermittent availability, or reduced reliability in patients receiving sedation, analgesia, mechanical ventilation, or organ support.
The pupillary light reflex is a classic component of neurological examination. Automated quantitative pupillometry provides objective and reproducible measurements of pupillary light reflex parameters, including pupil diameter, constriction velocity, dilation velocity, constriction percentage, maximum constriction velocity, and latency. These parameters may reflect brainstem reflex function, autonomic nervous system activity, medication effects, pain, circulatory status, and systemic stress responses in critically ill patients.
This study will enroll adult critically ill patients admitted to participating emergency intensive care units. After written informed consent is obtained from the participant or a legally authorized representative, baseline demographic data, primary diagnosis, disease severity scores, treatment information, organ support, sedation and analgesia status, vasoactive medication use, and vital signs will be collected. Pupillary light reflex parameters will be measured using a handheld automated quantitative pupillometer once daily during the first 7 days after EICU admission, or until EICU discharge or death, whichever occurs first. Additional measurements may be performed when clinically indicated.
The primary analysis will focus on the dynamic trajectory of constriction velocity during the early EICU period. Dilation velocity, pupil diameter, constriction percentage, maximum constriction velocity, and latency will be analyzed as supplementary pupillary light reflex parameters. Group-based trajectory modeling will be used to identify distinct longitudinal trajectory patterns of pupillary light reflex parameters.
The primary outcome is 90-day functional outcome assessed by the Glasgow Outcome Scale-Extended. Unfavorable functional outcome is defined as a GOS-E score of 4 or lower, and death during follow-up will be included in the GOS-E scoring system. The secondary outcome is discharge outcome, which will be analyzed primarily as a binary outcome. Favorable discharge outcome is defined as discharge home or transfer to a rehabilitation facility. Unfavorable discharge outcome is defined as in-hospital death, discharge to hospice or long-term care facility, or discharge against medical advice. Transfer to a higher-level hospital or another medical institution for continued treatment will be recorded as an indeterminate disposition and further followed when feasible.
This study will further evaluate whether dynamic trajectories of pupillary light reflex parameters provide additional prognostic value beyond conventional static measurements and clinical variables. No treatment assignment or intervention will be performed as part of this study. All clinical management decisions will be made by the treating physicians according to routine clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult critically ill patients admitted to the EICU | – | –Adult critically ill patients admitted to emergency intensive care units who meet the eligibility criteria will be enrolled in a single prospective observational cohort. Participants will undergo quantitative pupillometry during the first 7 days after EICU admission, or until EICU discharge or death, whichever occurs first. Clinical information, treatment data, discharge outcome, and 90-day functional outcome will be collected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult critically ill patients admitted to emergency intensive care units at participating tertiary hospitals will be screened for eligibility. Eligible patients are those expected to stay in the EICU for more than 48 hours and for whom reliable quantitative pupillometry can be performed. Written informed consent will be obtained from the participant or a legally authorized representative before enrollment.
Key inclusion criteria (4 listed)
- Age 18 years or older.
- Admission to the emergency intensive care unit.
- Critically ill patients with an expected EICU stay longer than 48 hours.
- Written informed consent obtained from the participant or legally authorized representative.
Key exclusion criteria (4 listed)
- Severe ocular disease, severe ocular trauma, postoperative ocular status, or other conditions that prevent reliable pupillary measurement.
- Known neuro-ophthalmic disorders that may affect the pupillary light reflex, such as oculomotor nerve palsy.
- Use of topical ophthalmic medications during the study period that may significantly affect pupillary response, when their effects cannot be accurately recorded or evaluated.
- Pregnancy or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
90-Day Functional Outcome Assessed by the Glasgow Outcome Scale-Extended
Time frame: 90 days after disease onset
Functional outcome will be assessed using the Glasgow Outcome Scale-Extended at 90 days after disease onset. Unfavorable functional outcome is defined as a GOS-E score of 4 or lower. Participants who die during follow-up will be included in the GOS-E scoring system, and the 90-day mortality rate will be reported separately.
1 secondary outcome
Discharge Outcome
Time frame: From EICU admission to hospital discharge; indeterminate transfers will be followed up to 90 days when feasible
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study involves sensitive clinical data from critically ill patients and data sharing is not currently covered by the informed consent or ethics approval. De-identified aggregate results will be reported in publications.
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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.
Mao Zhang, MD principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Pupillometry, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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 4 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: opening soon, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Danni Jin, MD (+8615825512455, 670251925@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
90-Day Functional Outcome Assessed by the Glasgow Outcome Scale-Extended (time frame: 90 days after disease onset). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jun 2026.