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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07867678
- Acronym / sponsor ID
- GOLDEN EYE / TERON AOIparaM 2025
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 9 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PPI (Pupillary Pain Index) | Experimental | Other: PPI Measurement (Pupillary Pain Index) |
| BPS (Behavioral Pain Scale) | Active comparator | Other: BPS Measurement (Behavioral Pain Scale) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient admitted to the ICU:
- Consent obtained from family members after they were informed about the study's procedures and objectives
Key exclusion criteria (10 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PPI Measurement (Pupillary Pain Index)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). | Other | PPI (Pupillary Pain Index) |
| BPS Measurement (Behavioral Pain Scale)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. | Other | BPS (Behavioral Pain Scale) |
Primary outcome
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christina TERON (03 80 28 13 03 ext. +33, Christina.teron@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.