Interest of Instantaneous Fluctuations of Pupillary Diameter for Pain Evaluation in Intensive Care Sedated Patients.
NCT ID: NCT05633069
Last Updated: 2022-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
120 participants
OBSERVATIONAL
2022-11-01
2022-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Guiding Significance of Pupil Monitoring in the Perioperative Period
NCT04820374
Assessment of Analgesics and Sedatives in Mechanically Ventilated Patients With COVID-19
NCT05336656
Physiological Data Analysis of Patients Undergoing Anesthesia for Liver Transplantation
NCT03694301
Assessing Pain in the Postoperative Period by Automatically Measuring the Variation Coefficient of Pupillary Diameter: PREVANS Study
NCT03267979
Influence of Variations of Systemic Venous Return on Analgesia Nociception Index (ANI) During General Anaesthesia
NCT02193412
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Patients requiring orotracheal intubation or tracheostomy
Patients 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 on the day of recording a Riker sedation score of 3 or 4 will be included.
Datas analysed by medical records.
Datas analysed by medical records
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Datas analysed by medical records
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* requiring orotracheal intubation or tracheostomy
* and presenting a Riker sedation score of 3 or 4.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Centre Hospitalier Universitaire de Saint Etienne
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
David CHARIER, MD
Role: PRINCIPAL_INVESTIGATOR
CHU SAINT-ETIENNE
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHU Saint-Etienne
Saint-Etienne, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRBN412014/CHUSTE
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.