Dynamic Trajectories of Pupillary Light Reflex Parameters and Prognosis in Critically Ill Patients: A Multicenter Prospective Cohort Study

NCT07616518 | Not Yet Recruiting

• 1 other identifier: 20260245
• Study Type: observational
• Target: 700
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Critical Illness; Pupillometry; Prognosis

Keywords

Pupillary light reflex; Critically ill patients; Dynamic trajectory; Prognosis; Constriction Velocity

Outcome Measures

Primary Outcomes (1)

• 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.

  90 days after disease onset

Secondary Outcomes (1)

• Discharge Outcome

  From EICU admission to hospital discharge; indeterminate transfers will be followed up to 90 days when feasible

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang Provincial People's Hospital: collaborator
• Jinhua Municipal Central Hospital: collaborator
• Lishui Country People's Hospital: collaborator
• Ningbo Medical Center Lihuili Hospital: collaborator
• The Second Affiliated Hospital of Jiaxing University: collaborator
• The Fourth Affiliated Hospital of Zhejiang University School of Medicine: collaborator
• The Third Affiliated Hospital of Wenzhou Medical University: collaborator
• Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University: collaborator
• People's Hospital of Quzhou: collaborator
• First People's Hospital of Hangzhou: collaborator
• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Zhejiang Provincial Tongde Hospital: collaborator
• Huzhou Central Hospital: collaborator
• Lishui Municipal Central Hospital: collaborator

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mao Zhang, MD

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Danni Jin, MD

CONTACT

+8615825512455; 670251925@qq.com

Study Design

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

Study Record Dates

• First Submitted: May 24, 2026
• First Posted: June 1, 2026
• Study Start: June 6, 2026
• Primary Completion (Estimated): October 13, 2026
• Study Completion (Estimated): October 13, 2026
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share