Automated Pupillometry and Delirium in Patients on Mechanical Ventilation in Intensive Care-intensive Care
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 209
- Locations
- 1
- Primary Endpoint
- Measurement of the parameters of the automated pupillometry
Study Overview
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.
Detailed Description
Automated pupillometry is an easy-to-use device that allows for accurate objective assessment of the photomotor reflex.
AP it allows the acquisition of dynamic parameters in addition to pupillary diameter, such as quantitative measurement of pupillary reactivity, speed, or latency of pupil contraction after a standardized light stimulus.
Automated pupillometry has been evaluated in ICU, in a monocentric study in non-brain-damaged patients, AP was used for the first time to predict the occurrence of delirium. Interestingly, the decrease in pupillary diameter variation at day 0 after 48h of IMV (D0) was independently associated with the occurrence of delirium during the ICU stay. This seems promising but requires a validation study in order to recommend its routine use.
The hypothesis is the AP parameters predict the risk of delirium in ICU-patients ventilated for more than 48 hours. Specifically, AP parameters on the D3 of mechanical ventilation allow predicting the occurrence of delirium during the first 14 days of resuscitation. This will allow early change of patient management, by identifying patients at risk of delirium and serious short-term adverse events.
This is a prospective, observational, multicenter cohort study involving 5 ICU in the Paris area.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults ≥ 18 years
- •mechanical ventilation since 48h
- •Information and no opposition of patient or close person if he is present at the time of inclusion, otherwise urgent inclusion
Exclusion Criteria
- •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)
Arms & Interventions
Patient
Adult patient hospitalized in ICU for a duration of mechanical ventilation longer than 48 hours
Intervention: Adult patient hospitalized in ICU (Other)
Outcomes
Primary Outcomes
Measurement of the parameters of the automated pupillometry
Time Frame: at day 0
Secondary Outcomes
- Number of days in intensive care(until day90)
- Death rate(at day90)
- Measurement of the parameters of the automated pupillometry in the subgroup of patients hospitalized for cardiogenic shock under veno-arterial circulatory support(day0)
- 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)
- Number of days of mechanical ventilation(until D14 or stopping invasive ventilation)
- Accidental catheter ablation rate(up to day14 resuscitation or resuscitation discharge)
- Early PREdiction of DELIRium in ICu patients (E-PRE-DELIRIC) score(at day 0)
- Measurement of the parameters of the automated pupillometry in the subgroup of patients hospitalized for sepsis(day0)
- Measurement of the parameters of the automated pupillometry(until 7 days)