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

NCT ID: NCT05469841

Last Updated: 2023-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-29
• Study Completion Date: 2023-03-28

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)

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).

Conditions

Critical Illness

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Pupillometry

Pain will be evaluated via pupillometry with 3 successive measurements

Group Type: EXPERIMENTAL

Systemic pain assessment

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Régional d'Orléans

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mai Anh NAY, MD

Role: STUDY_DIRECTOR

Regional Hospital Center of ORLEANS

Locations

Regional Hospital Center

Orléans, , France

Universitary Hospital Center

Tours, , France

Countries

France

Other Identifiers

CHRO-2022-04

Identifier Type: -

Identifier Source: org_study_id