CompletedNot Applicable

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

France120 participantsStarted 2022-11-01

Plain-language summary

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).

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

Timeframe: Months: 1

Trial details

NCT IDNCT05633069

SponsorCentre Hospitalier Universitaire de Saint Etienne

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-11-30