Clinical Research Directory

Pupillometry vs. BPS (Behavioral Pain Scale) for Analgesia Management in Inpatient Intensive Care Unit Patients on Invasive Mechanical Ventilation

Sponsor: Centre Hospitalier Universitaire Dijon

Summary

Patients admitted to the intensive care unit (ICU) and receiving invasive mechanical ventilation (IMV) frequently require sedation and analgesia to ensure their comfort, prevent pain associated with invasive procedures, and minimize complications related to agitation. Appropriate analgesia management is essential to ensure patient comfort while minimizing the consequences of excessive opioid exposure, including delirium, prolonged mechanical ventilation, extended ICU stays, and the risk of post-ICU syndrome (PICS). While sedation assessment relies on validated tools such as the RASS score, pain assessment in non-communicative patients remains more complex. In practice, it relies primarily on behavioral scales such as the Behavioral Pain Scale (BPS), the only internationally validated scale that has been translated into French and is recommended for use in intensive care. However, these scales have certain limitations, particularly in deeply sedated patients or when motor expression is impaired. Thus, over the past few years, automated pupillometry has been developed to assess pain through the pupillary dilation reflex (PDR), which is an autonomic physiological response to nociception. Indeed, pupillometry allows for the quantitative measurement of the PDR induced by standardized, noninvasive nociceptive stimulation. This measurement yields the Pupillary Pain Index (PPI), which serves as an objective, reproducible, and observer-independent indicator of nociception. Measuring the PPI could enable earlier and more individualized adjustment of analgesia, leading to a reduction in painful episodes and opioid exposure. In this context, this randomized study aims to compare, in patients on mechanical ventilation with deep sedation and analgesia (RASS -4/-5), a pain monitoring strategy guided by pupillometry with standard care based on the BPS. The objective is to evaluate the impact of this strategy on the frequency of pain event detection and on complications associated with opioid use in the intensive care unit

Official title: Pupillometry vs. BPS (Behavioral Pain Scale) for Analgesia Management in Inpatient Intensive Care Unit Patients on Invasive Mechanical Ventilation: A Multicenter, Randomized, Two-Arm Parallel-Group Study

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