Interest of Instantaneous Fluctuations of Pupillary Diameter for Pain Evaluation in Intensive Car… (NCT05633069) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
See this in plain English?
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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