NCT05469841

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Centre Hospitalier Régional d'Orléans · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-07-29
• Primary completion: 2023-03-28
• Completion: 2023-03-28
• First posted: 2022-07-22
• Last updated: 2023-04-03

Locations

2 sites across 1 country: France