NCT02847195

Pupillometry in Pediatric Intensive Care Unit (PICU)

Evaluation of Pupillometry to Assess Analgesia in Children Unable to Communicate Verbally in Pediatric Intensive Care Unit (PICU)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Assess the depth of sedation and analgesia in pediatric intensive care is critical to the management of intubated patients under mechanical ventilation. The responsiveness of the pupil is changed by the sedation and analgesia. Measuring the pupil diameter is proposed in anesthesia and intensive care to assess the quality of analgesia in adult population. Visually measuring the diameter of the pupil remains very imprecise, but this measure can be accurately and quickly performed thanks to portable devices called Pupillometers. Some devices including Algiscan® device (IdMed ) can measure in addition to the pupil diameter, the variation of pupil diameter, the latency of the pupillary reflex and the maximum speed of contraction. Pupillometry was tested in adult ICU patients, during painful and painless procedures \[1\]. In this study, pupillometry was more sensitive for detecting pain compared to the change in heart rate or bispectral index. The objective of this work is to perform measurements of pupil diameter during painful procedures (e.g. tracheal aspiration) in PICU. In parallel we will continue using the Comfort B-scale (has been validated for assessment of pain in children admitted to a pediatric intensive care unit \[2-5\] and compare the results of both types of assessment pain.

Conditions

• Pediatric Intensive Care

Interventions

Type	Name	Description
DEVICE	pupillometry	This is a safe and painless examination (the device is simply placed on the orbit of the eye). The optical pupillometer is cleaned by doctors before and after each use, using cleaning wipes containing antibacterial, antiviral and antifungal drugs; such wipes are already in use in the service for cleaning equipment.

Timeline

• Start date: 2014-12-02
• Primary completion: 2019-07-02
• Completion: 2019-07-02
• First posted: 2016-07-28
• Last updated: 2020-03-30

Locations

1 site across 1 country: France