Pupillometry and Nociception Level Index for the Evaluation of Pain in Intensive Care Unit.

NCT05469841 | Completed

• 1 other identifier: CHRO-2022-04
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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)

Conditions

Critical Illness

Keywords

pain; intensive care; sedated; ventilated; NOL ICU; pupillometry

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Nociception Level index

  1 hour during procedure

• Systolic and diastolic Blood pressure

  1 hour during procedure

• Heart rate

  1 hour during procedure

• Respiratory rate

  1 hour during procedure

• Behaviour Pain Scale

  1 hour during procedure

Study Arms (1)

Pupillometry

EXPERIMENTAL

Pain will be evaluated via pupillometry with 3 successive measurements

Other: Systemic pain assessment

Interventions

Systemic pain assessment OTHER

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.

Pupillometry

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Régional d'Orléans: lead

Study Sites (2)

Regional Hospital Center

Orléans, 45067, France

Location

Universitary Hospital Center

Tours, 37000, France

Location

MeSH Terms

Conditions

Critical Illness; Pain

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Mai Anh NAY, MD

  Regional Hospital Center of ORLEANS

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2022
• First Posted: July 22, 2022
• Study Start: July 29, 2022
• Primary Completion: March 28, 2023
• Study Completion: March 28, 2023
• Last Updated: April 3, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)