Pupillometry and Nociception Level Index for the Evaluation of Pain in Intensive Care Unit. (NOCI-ICU)

Pupillometry and Nociception Level Index (NOL-index) for the Evaluation of Pain in Intensive Care Unit. Prospective Study in Two Centers

Pain is a frequent symptom in the intensive care unit (ICU). Critical ill patients are often intubated and sedated which makes self-evaluation of pain impossible.

Pupillary dilatation is a reflex directly related to stimuli such as pain, which can be measured by quantitative pupillometry.

Several studies in ICU showed a significant relationship between pupillary diameter variation and pain.

The nociception level index (NOL-index) is a recent noninvasive and continuous monitoring of pain essentially used in operating room.

The aim of this study is to evaluate the pupillometry and NOL index in critical ill patients in sedated patients under mechanical ventilation during the mobilization plus toilet (described in literature as not painful procedure) and tracheal suctioning (described as a painful procedure)

Study Overview

• Status: Completed
• Conditions: Critical Illness
• Intervention / Treatment: Other: Systemic pain assessment

Detailed Description

Pain will be evaluated via i) pupillometry with 3 successive measurements ii) Behaviour Pain Scale (BPS) and Critical Care Pain Observation Tool (CPOT) score evaluated by an investigator (physician) iii) evolution of physiological parameters (ie heart rate, blood pressure, respiratory rate) iv) Nociception level index (NOL-index).

The evaluation times will be 5 minutes before care procedures (mobilization plus toilet and tracheal suctioning), during the procedures (with the worst value recorded) and 5 minutes after the procedures.

The procedures are:

• A mobilization and toilet of the patient: a priori, not a very painful procedure. The pain will be evaluated every 5 minutes during the toilet.
• Tracheal suctioning: a procedure known to be painful. The painful will be evaluated just at the end of tracheal suctioning (once the tracheal suctioning catheter is removed from the endotracheal intubation).

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Orléans, France, 45067
    • Regional Hospital Center
  • Tours, France, 37000
    • Universitary Hospital Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• older than18 years old
• Under invasive mechanical ventilation
• Sedated with i) a Richmond Agitation Sedation Scale (RASS) : ≥ -4 and <1, ii) being unable to evaluate their pain by a visual numeric scale

Exclusion Criteria:

• Ophthalmological diseases which could modify the pupillometric parameters
• Neurological diseases (damage of nerve III, intracranial hypertension, stroke)
• Admitted in ICU after resuscitated cardiac arrest
• Drugs that inhibit the effect of the sympathetic system (clonidine, dexmedetomidine)
• Patient under Veno-Arterial Extracorporeal Membrane Oxygenation (VA-ECMO)
• Patient treated by a neuromuscular blockade
• A do-not resuscitate order
• Major hemodynamic instability prohibiting planned care procedures

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pupillometry; Pain will be evaluated via pupillometry with 3 successive measurements	Other: Systemic pain assessment; Pain will be evaluated via i) pupillometry with 3 successive measurements ii) Behaviour Pain Scale (BPS) and Critical Care Pain Observation Tool (CPOT) score evaluated by an investigator (physician) iii) evolution of physiological parameters (ie heart rate, blood pressure, respiratory rate) iv) Nociception Level Index (NOL) index.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pupillary redilatation velocity after constriction light-induced	Area under the ROC curve (AUC) of pupillary re-dilation velocity measured before a potentially painful procedure to predict the occurrence of a BPS score ≥ 5 during the procedure.	1 hour during procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nociception Level index	To evaluate the predictive value of the NOL-index measured before a potentially painful procedure to predict the intensity of the pain felt during the procedure.	1 hour during procedure
Systolic and diastolic Blood pressure	Describe the variations of vital parameters	1 hour during procedure
Heart rate	Describe the variations of vital parameters	1 hour during procedure
Respiratory rate	Describe the variations of vital parameters	1 hour during procedure
Behaviour Pain Scale	Compare variations of nociception parameters during mobilizations and during tracheal aspirations Behaviour Pain Scale Score from 3 (no pain) to 12 (maximum pain)	1 hour during procedure

Collaborators and Investigators

• Sponsor: Centre Hospitalier Régional d'Orléans
• Investigators: Study Director: Mai Anh NAY, MD, Regional Hospital center of ORLEANS

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2022
• Primary Completion (Actual): March 28, 2023
• Study Completion (Actual): March 28, 2023

Study Registration Dates

• First Submitted: June 20, 2022
• First Submitted That Met QC Criteria: July 19, 2022
• First Posted (Actual): July 22, 2022

Study Record Updates

• Last Update Posted (Actual): April 3, 2023
• Last Update Submitted That Met QC Criteria: March 31, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: pain; intensive care; pupillometry; sedated; ventilated; NOL ICU
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: CHRO-2022-04

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