Pupillometry in Pediatric Intensive Care Unit (PICU) (Pupillomètre)

Civil Hospices of Lyon

Status: Completed

Conditions: Pediatric Intensive Care

Treatments: Device: pupillometry

Study type: Interventional

Funder types: Other

Identifiers

NCT02847195

69HCL15_0642

2013-A01600-45 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• children (age < 18 years) hospitalized in PICU
• sedated because they are receiving mechanical ventilation,
• for whom parents (or their representatives) have given their oral consent after written information.

Exclusion criteria

• children receiving curare drugs
• with congenital or acquired neurological,
• with ophthalmologic pathology
• or who does not benefit from social insurance coverage.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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66 participants in 1 patient group

pediatric intensive care

Experimental group

Description:

When aspiration is planned, pain assessment will be performed thrice : 3-5 minutes before aspiration, during aspiration, and 3-5 minutes after aspiration. Pain assessment will be performed with both methods: * COMFORT B scale (routinely performed by nurses, and lasts less than one minute) * Simultaneously pupillometry is assessed using the device (Neurolight) (one measurement per eye, this also lasts less than one minute) These measurements can occur at any time during stay in ICU, and can be repeated.

Treatment:

Device: pupillometry