PupillOmetry for Prediction of DelirIUM

NCT05248035 | Active Not Recruiting

• 2 other identifiers: APHP2011652020-A03517-32
• Study Type: observational
• Target: 213
• Locations: 1 country
• Sites: 1

Brief Summary

Delirium in intensive care unit (ICU) is a serious event. It is associated with short-term complications (agitation, self-extubation, accidental removal of catheters, prolonged length of stay and ventilation), excess mortality, functional and cognitive impairment. It is particularly frequent in patients requiring mechanical ventilation but diagnosis is not easy. There are screening scales, but it is insufficiently used in clinical practice: Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) or Intensive Care Delirium Screening Checklist (ICDSC). These scales are time consuming and require trained personnel. Automated pupillometry (AP) is a new device to objectively, rapidly, and reproducibly identify acute brain dysfunction. Recent data suggest that AP could be used to predict delirium in the ICU. This would need to be validated for routine use in the ICU. Evaluate AP parameters on day 3 of invasive mechanical ventilation as a predictive tool for CAM-ICU diagnosed delirium during the first 14 days of ICU stay. Study design: Prospective, multicenter, non-interventional cohort Measurement of the AP parameters at day 3 after ICU admission and their predictive performance for delirium: pupillary diameter, variation of the pupillary diameter, pupillary constriction speed, pupillary dilatation speed, photomotor reflex latency, NPi and symmetry of pupillary responses.

Conditions

Delirium; ICU

Keywords

Automated Pupillometry Delirium ICU

Outcome Measures

Primary Outcomes (1)

• Measurement of the parameters of the automated pupillometry

  at day 0

Secondary Outcomes (10)

• Measurement of the parameters of the automated pupillometry

  until 7 days

• Rate of agitated patients (agitation is defined by a Richmond Agitation-Sedation Scale > +1(RASS score: +4; -5 with 0= better outcome) requiring use of neuroleptics or dexmedetomidine)

  until day14 of resuscitation or discharge from resuscitation

• Self-extubation rate

  until day14 or stop invasive ventilation

• Accidental catheter ablation rate

  up to day14 resuscitation or resuscitation discharge

• Number of days of mechanical ventilation

  until D14 or stopping invasive ventilation

Study Arms (1)

Patient

Adult patient hospitalized in ICU for a duration of mechanical ventilation longer than 48 hours

Other: Adult patient hospitalized in ICU

Interventions

Adult patient hospitalized in ICU OTHER

acquisition of dynamic parameters in addition to pupillary diameter, such as . pupillary diameter, variation of the pupillary diameter, pupillary constriction speed, pupillary dilatation speed, photomotor reflex latency, NPi and symmetry of pupillary responses after a standardized light stimulus

Patient

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 patient hospitalized in ICU for a duration of mechanical ventilation longer than 48 hours

You may qualify if:

• Adults ≥ 18 years
• mechanical ventilation since 48h

You may not qualify if:

• Patient diagnosed confused by CAM-ICU on D0
• Ophthalmological pathology modifying the photomotor reflex
• Acute or chronic neurological pathology: Cerebro-injured patients (head trauma, stroke, cardiopulmonary arrest, hypoglycemic coma, meningitis / encephalitis / brain abscess), dementia with MMSE \<24
• Duration of stay in intensive care\> 72h or duration of ventilation\> 72h
• Readmission in intensive care
• Moribund patient
• Patient under guardianship or curatorship
• No affiliation to social security (beneficiary or assignee)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Bichat-Claude Bernard

Paris, 75018, France

Location

Related Publications (1)

• Jaquet P, Couffignal C, Tardivon C, Godard V, Bellot R, Assouline B, Benghanem S, Da Silva D, Decavele M, Dessajan J, Hermann B, Rambaud T, Voiriot G, Sonneville R; PODIUM Study Group. PupillOmetry for preDIction of DeliriUM in ICU (PODIUM): protocol for a prospective multicentre cohort study. BMJ Open. 2023 Jul 12;13(7):e072095. doi: 10.1136/bmjopen-2023-072095.

  PMID: 37438060 DERIVED

MeSH Terms

Conditions

Delirium

Interventions

Intensive Care Units

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Hospital Units; Health Facilities; Health Care Facilities Workforce and Services

Study Officials

• Pierre Jaquet, MD

  Assistance Publique Hopitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 9, 2021
• First Posted: February 21, 2022
• Study Start: April 15, 2022
• Primary Completion: November 15, 2024
• Study Completion: March 1, 2026
• Last Updated: January 12, 2026

Record last verified: 2026-01

Locations

FR (1)