PupillometryGOLDEN EYENCT07867678
Pupillometry vs. BPS (Behavioral Pain Scale) for Analgesia Management in Inpatient Intensive Care Unit Patients on Invasive Mechanical Ventilation
A study testing PPI Measurement (Pupillary Pain Index) and BPS Measurement (Behavioral Pain Scale) in people with Pupillometry and Behavioral Pain Scale, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pupillometry, Behavioral Pain Scale, Analgesia Assessment
- What is being tested?
- PPI Measurement (Pupillary Pain Index) and BPS Measurement (Behavioral Pain Scale)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2026to Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- - 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Chu Dijon Bourgogne
Dijon, 21000
Christina TERON, 03 80 28 13 03 ext. +33, Christina.teron@chu-dijon.fr
About this study
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
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
- Being tested
- PPI Measurement (Pupillary Pain Index), BPS Measurement (Behavioral Pain Scale)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
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.
| Study group | Role | What they receive |
|---|---|---|
| PPI (Pupillary Pain Index) | Experimental | Not described Receives: Other: PPI Measurement (Pupillary Pain Index) |
| BPS (Behavioral Pain Scale) | Active comparator | Not described Receives: Other: BPS Measurement (Behavioral Pain Scale) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Duration during which the patient is on VMI during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PupillometryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07867678
- Sponsor's protocol ID
- TERON AOIparaM 2025
- Acronym
- GOLDEN EYE
- Status last verified
- Oct 2026
- First submitted
- 2 Oct 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No