About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
Locations
Sponsors and contacts
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Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead sponsor
Zhejiang Provincial People's Hospital
Collaborator
Zhejiang Provincial Tongde Hospital
Collaborator
Jinhua Municipal Central Hospital
Collaborator
Huzhou Central Hospital
Collaborator
Lishui Country People's Hospital
Collaborator
Lishui Municipal Central 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
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