Pupillometry in Pediatric Intensive Care Unit (PICU)

Pediatric Intensive Care Clinical Trial

— Pupillomètre  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02847195
• Other study ID #: 69HCL15_0642
• Secondary ID: 2013-A01600-45
• Status: Completed
• Phase: N/A
• Start date: December 2, 2014
• Est. completion date: July 2, 2019

Study information

• Verified date: March 2020
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: July 2, 2019
• Est. primary completion date: July 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pediatric Intensive Care

Intervention

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.

Locations

Country	Name	City	State
France	service de réanimation pédiatrique, Hôpital Femme Mère Enfant (HFME), Hospices Civils de Lyon, 59 Boulevard Pinel	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pupillary diameter	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).	Day 1
Primary	Comfort B Score	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).	Day 1
Secondary	Latency time	Latency time assessed by the video pupillometer	Day 1
Secondary	pupil diameter variation	Pupil diameter variation assessed by the video pupillometer	Day 1
Secondary	diameter variation time	Diameter variation time assessed by the video pupillometer	Day 1