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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

700 Participants
are grouped into 1 trial group
Group A: Adult critically ill patients admitted to the EICU

Trial outcomes

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.

Time frame
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.

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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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