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).

Study Overview

• Status: Completed
• Conditions: Intubation Complication
• Intervention / Treatment: Other: Datas analysed by medical records

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• France
  • Saint-Étienne, France, 42055
    • CHU Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between fluctuations in Pupillary Diameter (PD), as assessed by the Variation Coefficient of Pupillary Diameter (VCPD) and the level of pain.	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.	Months: 1

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2022
• Primary Completion (ACTUAL): November 30, 2022
• Study Completion (ACTUAL): November 30, 2022

Study Registration Dates

• First Submitted: November 21, 2022
• First Submitted That Met QC Criteria: November 21, 2022
• First Posted (ACTUAL): December 1, 2022

Study Record Updates

• Last Update Posted (ACTUAL): December 5, 2022
• Last Update Submitted That Met QC Criteria: December 2, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Intensive Care Unit; Pain monitoring; Fluctuation of pupillary diameter; Variation coefficient of pupillary diameter; Behavioral Pain Scale; Videopupillometer
• Other Study ID Numbers: IRBN412014/CHUSTE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No