DeliriumPODIUMNCT05248035
PupillOmetry for Prediction of DelirIUM
An observational study of Delirium and ICU, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Delirium in intensive care unit (ICU) is a serious event. It is associated with short-term complications (agitation, self-extubation, accidental removal of catheters, prolonged length of stay and ventilation), excess mortality, functional and cognitive impairment. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Adult patient hospitalized in ICU
- How many people
- 209 participants
- Where
- 1 siteFrance
- Study dates
- 15 Apr 2022to 24 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Adult patient hospitalized in ICU for a duration of mechanical ventilation longer than 48 hours
Who may be able to join
- Adults ≥ 18 years
- mechanical ventilation since 48h
- Information and no opposition of patient or close person if he is present at the time of inclusion, otherwise urgent inclusion
Who cannot join
- Patient diagnosed confused by CAM-ICU on D0
- Ophthalmological pathology modifying the photomotor reflex
- Acute or chronic neurological pathology: Cerebro-injured patients (head trauma, stroke, cardiopulmonary arrest, hypoglycemic coma, meningitis / encephalitis / brain abscess), dementia with MMSE <24
- Duration of stay in intensive care> 72h or duration of ventilation> 72h
- Readmission in intensive care
- Moribund patient
- Patient under guardianship or curatorship
- No affiliation to social security (beneficiary or assignee)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Automated Pupillometry and Delirium in Patients on Mechanical Ventilation in Intensive Care-intensive Care
Delirium in intensive care unit (ICU) is a serious event. It is associated with short-term complications (agitation, self-extubation, accidental removal of catheters, prolonged length of stay and ventilation), excess mortality, functional and cognitive impairment. It is particularly frequent in patients requiring mechanical ventilation but diagnosis is not easy. There are screening scales, but it is insufficiently used in clinical practice: Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) or Intensive Care Delirium Screening Checklist (ICDSC). These scales are time consuming and require trained personnel. Automated pupillometry (AP) is a new device to objectively, rapidly, and reproducibly identify acute brain dysfunction. Recent data suggest that AP could be used to predict delirium in the ICU. This would need to be validated for routine use in the ICU.
Evaluate AP parameters on day 3 of invasive mechanical ventilation as a predictive tool for CAM-ICU diagnosed delirium during the first 14 days of ICU stay.
Read more
Study design: Prospective, multicenter, non-interventional cohort
Measurement of the AP parameters at day 3 after ICU admission and their predictive performance for delirium: pupillary diameter, variation of the pupillary diameter, pupillary constriction speed, pupillary dilatation speed, photomotor reflex latency, NPi and symmetry of pupillary responses.
Read the detailed description
Automated pupillometry is an easy-to-use device that allows for accurate objective assessment of the photomotor reflex.
AP it allows the acquisition of dynamic parameters in addition to pupillary diameter, such as quantitative measurement of pupillary reactivity, speed, or latency of pupil contraction after a standardized light stimulus.
Automated pupillometry has been evaluated in ICU, in a monocentric study in non-brain-damaged patients, AP was used for the first time to predict the occurrence of delirium. Interestingly, the decrease in pupillary diameter variation at day 0 after 48h of IMV (D0) was independently associated with the occurrence of delirium during the ICU stay. This seems promising but requires a validation study in order to recommend its routine use.
The hypothesis is the AP parameters predict the risk of delirium in ICU-patients ventilated for more than 48 hours. Specifically, AP parameters on the D3 of mechanical ventilation allow predicting the occurrence of delirium during the first 14 days of resuscitation. This will allow early change of patient management, by identifying patients at risk of delirium and serious short-term adverse events.
This is a prospective, observational, multicenter cohort study involving 5 ICU in the Paris area.
To ensure the 213 planned inclusions and the 3-month follow-up of all included patients, a research duration of 15 months is expected. The ethical committee of the French Society of intensive care medicine (FICS) approved the study protocol (CE SRLF 20-09) and required Family members' informed consent.
At D0, patient is included and we start to evaluate AP parameter twice a day from D0 to D7 and to monitor delirium occurrence using Confusion assessment monitoring in the ICU (CAM ICU).
We assess changes in AP parameters from D0 to D7 of mechanical ventilation in patients with and without CAM-ICU diagnosed delirium during the first 14 days of ICU stay.
Automated pupillometry protocol : The AP is measured for each eye from D0 onwards, twice a day, as long as the patient is under mechanical ventilation and up to a maximum of 7 days (D7), using the NPI Neuroptics® device. These parameters were measured by the nurses or by the investigating physician not involved in the patient's care. At each measurement point, the mean value of both eyes was used for the analyses. The AP parameters are: pupillary diameter, variation of the pupillary diameter, pupillary constriction speed, pupillary dilatation speed, photomotor reflex latency, NPi and symmetry of pupillary responses. Routine neurological monitoring in ICU includes the RASS score every 4 hours. If the RASS score is ≥ -3 then CAM-ICU will be administered twice daily starting on day 3 by the patient's attending physicians. The physicians in charge of the patient will be blinded to the AP results.
- Being tested
- Adult patient hospitalized in ICU
- Keywords
- Automated Pupillometry Delirium ICU
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adult patient hospitalized in ICUOther
acquisition of dynamic parameters in addition to pupillary diameter, such as . pupillary diameter, variation of the pupillary diameter, pupillary constriction speed, pupillary dilatation speed, photomotor reflex latency, NPi and symmetry of pupillary responses after a standardized light stimulus
| Study group | Role | What they receive |
|---|---|---|
| Patient | Adult patient hospitalized in ICU for a duration of mechanical ventilation longer than 48 hours Receives: Other: Adult patient hospitalized in ICU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the parameters of the automated pupillometry
Measured: at day 0
Secondary outcomes (10)
Measurement of the parameters of the automated pupillometry
Measured: until 7 days
Rate of agitated patients (agitation is defined by a Richmond Agitation-Sedation Scale > +1(RASS score: +4; -5 with 0= better outcome) requiring use of neuroleptics or dexmedetomidine)
Measured: until day14 of resuscitation or discharge from resuscitation
Self-extubation rate
Measured: until day14 or stop invasive ventilation
Accidental catheter ablation rate
Measured: up to day14 resuscitation or resuscitation discharge
Number of days of mechanical ventilation
Measured: until D14 or stopping invasive ventilation
Number of days in intensive care
Measured: until day90
Death rate
Measured: at day90
Early PREdiction of DELIRium in ICu patients (E-PRE-DELIRIC) score
Measured: at day 0
Measurement of the parameters of the automated pupillometry in the subgroup of patients hospitalized for sepsis
Measured: day0
Measurement of the parameters of the automated pupillometry in the subgroup of patients hospitalized for cardiogenic shock under veno-arterial circulatory support
Measured: day0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start15 Apr 2022
- Primary completion15 Nov 2024
- Study completion24 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Jaquet, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05248035
- Sponsor's protocol ID
- APHP201165
- Other IDs
- 2020-A03517-32
- Acronym
- PODIUM
- Status last verified
- Jan 2026
- First submitted
- 9 Dec 2021
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Jaquet P, Couffignal C, Tardivon C, Godard V, Bellot R, Assouline B, Benghanem S, Da Silva D, Decavele M, Dessajan J, Hermann B, Rambaud T, Voiriot G, Sonneville R; PODIUM Study Group. PupillOmetry for preDIction of DeliriUM in ICU (PODIUM): protocol for a prospective multicentre cohort study. BMJ Open. 2023 Jul 12;13(7):e072095. doi: 10.1136/bmjopen-2023-072095.
PubMed 37438060
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Pupillometry and Delirium in Patients on Mechanical Ventilation in Intensive Care-intensive Care
- ClinicalTrials.gov ID
- NCT05248035
- Acronym / sponsor ID
- PODIUM / APHP201165
- Keywords
- Automated Pupillometry Delirium ICU
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 15 Nov 2024 (actual)
- Study completion
- 24 Jul 2026 (actual)
- First posted
- 21 Feb 2022 (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.
Delirium in intensive care unit (ICU) is a serious event. It is associated with short-term complications (agitation, self-extubation, accidental removal of catheters, prolonged length of stay and ventilation), excess mortality, functional and cognitive impairment. It is particularly frequent in patients requiring mechanical ventilation but diagnosis is not easy. There are screening scales, but it is insufficiently used in clinical practice: Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) or Intensive Care Delirium Screening Checklist (ICDSC). These scales are time consuming and require trained personnel. Automated pupillometry (AP) is a new device to objectively, rapidly, and reproducibly identify acute brain dysfunction. Recent data suggest that AP could be used to predict delirium in the ICU. This would need to be validated for routine use in the ICU.
Evaluate AP parameters on day 3 of invasive mechanical ventilation as a predictive tool for CAM-ICU diagnosed delirium during the first 14 days of ICU stay.
Study design: Prospective, multicenter, non-interventional cohort
Measurement of the AP parameters at day 3 after ICU admission and their predictive performance for delirium: pupillary diameter, variation of the pupillary diameter, pupillary constriction speed, pupillary dilatation speed, photomotor reflex latency, NPi and symmetry of pupillary responses.
Detailed description
Automated pupillometry is an easy-to-use device that allows for accurate objective assessment of the photomotor reflex.
AP it allows the acquisition of dynamic parameters in addition to pupillary diameter, such as quantitative measurement of pupillary reactivity, speed, or latency of pupil contraction after a standardized light stimulus.
Automated pupillometry has been evaluated in ICU, in a monocentric study in non-brain-damaged patients, AP was used for the first time to predict the occurrence of delirium. Interestingly, the decrease in pupillary diameter variation at day 0 after 48h of IMV (D0) was independently associated with the occurrence of delirium during the ICU stay. This seems promising but requires a validation study in order to recommend its routine use.
The hypothesis is the AP parameters predict the risk of delirium in ICU-patients ventilated for more than 48 hours. Specifically, AP parameters on the D3 of mechanical ventilation allow predicting the occurrence of delirium during the first 14 days of resuscitation. This will allow early change of patient management, by identifying patients at risk of delirium and serious short-term adverse events.
This is a prospective, observational, multicenter cohort study involving 5 ICU in the Paris area.
To ensure the 213 planned inclusions and the 3-month follow-up of all included patients, a research duration of 15 months is expected. The ethical committee of the French Society of intensive care medicine (FICS) approved the study protocol (CE SRLF 20-09) and required Family members' informed consent.
At D0, patient is included and we start to evaluate AP parameter twice a day from D0 to D7 and to monitor delirium occurrence using Confusion assessment monitoring in the ICU (CAM ICU).
We assess changes in AP parameters from D0 to D7 of mechanical ventilation in patients with and without CAM-ICU diagnosed delirium during the first 14 days of ICU stay.
Automated pupillometry protocol : The AP is measured for each eye from D0 onwards, twice a day, as long as the patient is under mechanical ventilation and up to a maximum of 7 days (D7), using the NPI Neuroptics® device. These parameters were measured by the nurses or by the investigating physician not involved in the patient's care. At each measurement point, the mean value of both eyes was used for the analyses. The AP parameters are: pupillary diameter, variation of the pupillary diameter, pupillary constriction speed, pupillary dilatation speed, photomotor reflex latency, NPi and symmetry of pupillary responses. Routine neurological monitoring in ICU includes the RASS score every 4 hours. If the RASS score is ≥ -3 then CAM-ICU will be administered twice daily starting on day 3 by the patient's attending physicians. The physicians in charge of the patient will be blinded to the AP results.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient | – | Other: Adult patient hospitalized in ICUAdult patient hospitalized in ICU for a duration of mechanical ventilation longer than 48 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patient hospitalized in ICU for a duration of mechanical ventilation longer than 48 hours
Key inclusion criteria (3 listed)
- Adults ≥ 18 years
- mechanical ventilation since 48h
- Information and no opposition of patient or close person if he is present at the time of inclusion, otherwise urgent inclusion
Key exclusion criteria (8 listed)
- Patient diagnosed confused by CAM-ICU on D0
- Ophthalmological pathology modifying the photomotor reflex
- Acute or chronic neurological pathology: Cerebro-injured patients (head trauma, stroke, cardiopulmonary arrest, hypoglycemic coma, meningitis / encephalitis / brain abscess), dementia with MMSE <24
- Duration of stay in intensive care> 72h or duration of ventilation> 72h
- Readmission in intensive care
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 |
|---|---|---|
| Adult patient hospitalized in ICUacquisition of dynamic parameters in addition to pupillary diameter, such as . pupillary diameter, variation of the pupillary diameter, pupillary constriction speed, pupillary dilatation speed, photomotor reflex latency, NPi and symmetry of pupillary responses after a standardized light stimulus | Other | Patient |
Primary outcome
Measurement of the parameters of the automated pupillometry
Time frame: at day 0
10 secondary outcomes
Measurement of the parameters of the automated pupillometry
Time frame: until 7 days
Rate of agitated patients (agitation is defined by a Richmond Agitation-Sedation Scale > +1(RASS score: +4; -5 with 0= better outcome) requiring use of neuroleptics or dexmedetomidine)
Time frame: until day14 of resuscitation or discharge from resuscitation
Self-extubation rate
Time frame: until day14 or stop invasive ventilation
Accidental catheter ablation rate
Time frame: up to day14 resuscitation or resuscitation discharge
Number of days of mechanical ventilation
Time frame: until D14 or stopping invasive ventilation
Number of days in intensive care
Time frame: until day90
Death rate
Time frame: at day90
Early PREdiction of DELIRium in ICu patients (E-PRE-DELIRIC) score
Time frame: at day 0
Measurement of the parameters of the automated pupillometry in the subgroup of patients hospitalized for sepsis
Time frame: day0
Measurement of the parameters of the automated pupillometry in the subgroup of patients hospitalized for cardiogenic shock under veno-arterial circulatory support
Time frame: day0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Derived from this study: PubMed 37438060Jaquet P, Couffignal C, Tardivon C, Godard V, Bellot R, Assouline B, Benghanem S, Da Silva D, Decavele M, Dessajan J, Hermann B, Rambaud T, Voiriot G, Sonneville R; PODIUM Study Group. PupillOmetry for preDIction of DeliriUM in ICU (PODIUM): protocol for a prospective multicentre cohort study. BMJ Open. 2023 Jul 12;13(7):e072095. doi: 10.1136/bmjopen-2023-072095.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Pierre Jaquet, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium and ICU, run by Assistance Publique - Hôpitaux de Paris 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 3 inclusion and 8 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: finished, as of the sponsor's last update on 12 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of the parameters of the automated pupillometry (time frame: at day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05248035, which also lists 1 linked publication.
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 12 Aug 2026.