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

NCT07867678 | Not Yet Recruiting

• 1 other identifier: TERON AOIparaM 2025
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Pupillometry; Behavioral Pain Scale; Analgesia Assessment; Intensive Care Unit (ICU)

Outcome Measures

Primary Outcomes (1)

• 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.

  Duration during which the patient is on VMI during the procedure

Study Arms (2)

PPI (Pupillary Pain Index)

EXPERIMENTAL

Other: PPI Measurement (Pupillary Pain Index)

BPS (Behavioral Pain Scale)

ACTIVE COMPARATOR

Other: BPS Measurement (Behavioral Pain Scale)

Interventions

PPI Measurement (Pupillary Pain Index) OTHER

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).

PPI (Pupillary Pain Index)

BPS Measurement (Behavioral Pain Scale) OTHER

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.

BPS (Behavioral Pain Scale)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient admitted to the ICU:
• On mechanical ventilation
• And requiring sedation and analgesia
• With a RASS score between -4 and -5
• And a BPS
• Consent obtained from family members after they were informed about the study's procedures and objectives

You may not qualify if:

• \- A family member who refuses the patient's participation
• Patients under 18 years of age
• Patients who are not enrolled in or eligible for a social security program
• Individuals subject to legal protective measures (guardianship, conservatorship)
• Individuals subject to judicial protective measures
• Inmates or individuals deprived of their liberty
• Pregnant, laboring, or breastfeeding women
• Patients with a pacemaker
• Patients with one or more conditions likely to interfere with the RDP: patients who have undergone bilateral iridectomy, patients on barbiturates, those with acute brain injury, bilateral non-reactive mydriasis, cardiac arrest, substance abuse, an ophthalmological condition affecting the third cranial nerve or the pupils, intracranial hypertension, use of atropine- or epinephrine-based eye drops, or treatment with morphine for more than 3 months
• Patients with one or more conditions that may interfere with BPS measurement: use of neuromuscular blocking agents, neuromuscular disease (myopathy, Charcot's disease, myositis), or resuscitation-associated neuromyopathy preventing BPS measurement

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourgogne

Dijon, 21000, France

Location

Central Study Contacts

Christina TERON

CONTACT

03 80 28 13 03; Christina.teron@chu-dijon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2026
• First Posted: October 9, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: October 9, 2026

Record last verified: 2026-10

Locations

FR (1)