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

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne (Other)
• Overall Status: Completed
• CT.gov ID: NCT05633069
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Actual Duration (Days): 29
• Patients Per Site Per Month: 125.9

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Intubation Complication	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 Design

• Study Type: Observational
• Actual Enrollment: 120 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Interest of Instantaneous Fluctuations of Pupillary Diameter for Pain Evaluation in Intensive Care Sedated Patients.
• Actual Study Start Date: Nov 1, 2022
• Actual Primary Completion Date: Nov 30, 2022
• Actual Study Completion Date: Nov 30, 2022

Arms and Interventions

Arm

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Saint-Etienne	Saint-Étienne		France	42055

Sponsors and Collaborators

• Centre Hospitalier Universitaire de Saint Etienne

Investigators

• Principal Investigator: David CHARIER, MD, CHU Saint-Etienne

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
• ClinicalTrials.gov Identifier: NCT05633069
• Other Study ID Numbers: IRBN412014/CHUSTE
• First Posted: Dec 1, 2022
• Last Update Posted: Dec 5, 2022
• Last Verified: Dec 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Centre Hospitalier Universitaire de Saint Etienne: Fluctuation of pupillary diameter; Variation coefficient of pupillary diameter; Pain monitoring; Behavioral Pain Scale; Videopupillometer; Intensive Care Unit

Study Results

No Results Posted as of Dec 5, 2022