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Completed

NCT Number: NCT02847195

Pupillometry in Pediatric Intensive Care Unit (PICU)

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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Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

service de réanimation pédiatrique, Hôpital Femme Mère Enfant (HFME), Hospices Civils de Lyon, 59 Boulevard Pinel

Bron, 69500, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pupillometry

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.

Primary outcomes

  1. pupillary diameter

    Time frame: Day 1

    Estimate the performances of the variation of the pupillary diameter to assess pain in children admitted in PICU in comparison to results from the COMFORT-B scale taken as reference.

    Pupillometry is assessed using a specific device the Neurolight™ (ID MED™, France), (diagnostic test under evaluation), and compared to pain assessment using the score Comfort B scale ( hetero score assessment of pain in children sedated routinely used in PICU to evaluate pain).

  2. Comfort B Score

    Time frame: Day 1

    Estimate the performances of the variation of the pupillary diameter to assess pain in children admitted in PICU in comparison to results from the COMFORT-B scale taken as reference.

    Pupillometry is assessed using a specific device the Neurolight™ (ID MED™, France), (diagnostic test under evaluation), and compared to pain assessment using the score Comfort B scale ( hetero score assessment of pain in children sedated routinely used in PICU to evaluate pain).

Secondary outcomes

  1. Latency time

    Time frame: Day 1

    Latency time assessed by the video pupillometer

  2. pupil diameter variation

    Time frame: Day 1

    Pupil diameter variation assessed by the video pupillometer

  3. diameter variation time

    Time frame: Day 1

    Diameter variation time assessed by the video pupillometer

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: Pupillomètre

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Jul 28, 2016
Registry last updated
Mar 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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