An interventional study of PPI Measurement (Pupillary Pain Index) and BPS Measurement (Behavioral Pain Scale) in Pupillometry, Behavioral Pain Scale and Analgesia Assessment, sponsored by Centre Hospitalier Universitaire Dijon. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Centre Hospitalier Universitaire Dijon · Not applicable, Interventional, and Supportive care
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
Centre Hospitalier Universitaire Dijon is the lead sponsor of 499 studies on the registry; 104 are open to participants now.
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Patient admitted to the ICU:
Exclusion Criteria:
Other: PPI Measurement (Pupillary Pain Index)
Other: BPS Measurement (Behavioral Pain Scale)
Pain management will follow the protocol for adjusting daily doses of sufentanil or remifentanil to best tailor the doses to patients' needs, based on the results of pupillometry: • A PPI \< 4 allows for a reduction in sufentanil doses by 2.5 gamma/h or remifentanil doses by 0.02 µg/kg/min • A PPI between 4 and 6 does not require any changes to sufentanil or remifentanil doses • And a PPI \> 6 indicates the need to prescribe, in addition to sufentanil or remifentanil, a Step I or II analgesic, with a subsequent reassessment of the level of nociception (based on the duration and peak effect of the administered medications).
The BPS scale used to assess pain involves observing three criteria rated on a scale of 1 to 4: facial expression, upper limb tone, and adaptation to the ventilator. Thus, the BPS ranges from 3 (minimum score) to 12 (maximum pain score measurable with this tool). This measurement is simple to perform and is now fully mastered by healthcare teams working in intensive care units.
Average percentage of daily painful events during the period in which the patient is on VMI with RASS-4/-5, defined as the ratio of the daily number of painful events to the number of potentially painful procedures performed.
Average percentage of daily painful events during the period in which the patient is on VMI with RASS-4/-5, defined as the ratio of the daily number of painful events to the number of potentially painful procedures performed.
Time frame: Duration during which the patient is on VMI during the procedure
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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