Interest of Instantaneous Fluctuations of Pupillary Diameter for Pain Evaluation in Intensive Care Sedated Patients.

New pain assessment parameter, called the Variation Coefficient of Pupillary Diameter (VCPD) described. This parameter allows evaluating the pain of patients during uterine contractions in obstetrical labor, and postoperatively in recovery room.

This parameter also allows evaluating the level of pain in Intensive Care Unit (ICU), in intubated or tracheotomized patients moderately sedated (Riker score 3 or 4).

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Key information

Conditions

Intubation Complication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Saint-Etienne

Saint-Etienne, 42055, France

About this study

This study propose to recalculate the Variation Coefficient of Pupillary Diameter (VCPD) from pupil recordings performed in the Intensive Care Unit (ICU) in 2015-2016 and kept in the patients' records. From there, the Variation Coefficient of Pupillary Diameter (VCPD) will compare to the Behavioral Pain Scale (BPS), considered the gold standard pain assessment

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

hospitalized in the surgical Intensive Care Unit (ICU) of the University Hospital of Saint-Etienne between September 2015 and August 2016 for medical-surgical pathologies
requiring orotracheal intubation or tracheostomy
and presenting a Riker sedation score of 3 or 4.

Exclusion criteria

cerebral palsy
curarization
paraplegia or tetraplegia
intensive care neuromyopathy
ocular pathology
history of severe dysautonomic disease that could influence the evaluation of the Behavioral Pain Scale (BPS) or Variation Coefficient of Pupillary Diameter (VCPD) score
receiving antiarrhythmic treatment that could make the interpretation of the results difficult
on metoclopramide, droperidol, clonidine, or dexmedetomidine, which are known to alter the pupil dilation reflex.

Treatment and study plan

Datas analysed by medical records

Other

Datas analysed by medical records : pupillary parameters: pupillary diameter and pupillary diameter variation. heart rate, the blood pressure, the Behavioral Pain Scale (BPS) pain score before and during painful procedures.

The pupillary parameters were recorded with the AlgiScan® pupillometer (iDMed, Marseille, France), which allows the recording of Pupillary Diameter (PD) variations at the patient's bed at a sampling frequency of 67 hertz.

Primary outcomes

Correlation between fluctuations in Pupillary Diameter (PD), as assessed by the Variation Coefficient of Pupillary Diameter (VCPD) and the level of pain.

Time frame: Months: 1

Variation Coefficient of Pupillary Diameter (VCPD) calculate from continuous pupil recordings during tracheal aspirations, considered as a painful procedure.

The nurse in charge of the patient scored the Riker sedation score before endotracheal suctioning and the pain level estimated by the Behavioral Pain Scale (BPS) scale before and during endotracheal suctioning.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2022
First posted: Dec 1, 2022
Registry last updated: Dec 5, 2022

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.

Published trials that share one or more normalized conditions with this study.

Completed