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

Not Applicable

Completed

• Conditions: Critical Illness
• Interventions: Other: Systemic pain assessment

• Registration Number: NCT05469841
• Lead Sponsor: Centre Hospitalier Régional d'Orléans

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).

Study Timeline

• Study First Submitted: 2022-06-20
• Study First Submitted QC: 2022-07-19
• Study First Posted: 2022-07-22
• Study Start: 2022-07-29
• Status Verified: 2023-03
• Primary Completion: 2023-03-28
• Study Completion: 2023-03-28
• Last Update Submitted: 2023-03-31
• Last Update Posted: 2023-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pupillometry	Systemic pain assessment	Pain will be evaluated via pupillometry with 3 successive measurements

Primary Outcome Measures

Name	Time	Method
pupillary redilatation velocity after constriction light-induced	1 hour during procedure	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.

Secondary Outcome Measures

Name	Time	Method
Heart rate	1 hour during procedure	Describe the variations of vital parameters
Respiratory rate	1 hour during procedure	Describe the variations of vital parameters
Behaviour Pain Scale	1 hour during procedure	Compare variations of nociception parameters during mobilizations and during tracheal aspirations Behaviour Pain Scale Score from 3 (no pain) to 12 (maximum pain)
Nociception Level index	1 hour during procedure	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.
Systolic and diastolic Blood pressure	1 hour during procedure	Describe the variations of vital parameters

Trial Locations

Locations (2)

Universitary Hospital Center; 🇫🇷 Tours, France

Regional Hospital Center; 🇫🇷 Orléans, France