Pupillometry in Pediatric Intensive Care Unit (PICU)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-02

Study Completion Date

2019-07-02

Brief Summary

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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.

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Detailed Description

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Conditions

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Pediatric Intensive Care

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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pediatric intensive care

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.

Group Type EXPERIMENTAL

pupillometry

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No