DeliriumNCT05811208
Use of Pupillometry for Pain Assessment in ICU Patients With Delirium
An observational study of Delirium and Pain, Postoperative, run by St. Anne's University Hospital Brno, Czech Republic at 1 site in Czechia.
Trial summary
Pain assessment in intensive care patients is a constant challenge. Approximately 50% to 80% of patients report pain at rest or during medical or nursing interventions (for example endotracheal suctioning, mobilization and rehabilitation, presence and care of invasive inputs, etc.). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium, Pain, Postoperative
- What is being tested?
- automated pupillometry and questionnaire
- Type of treatment
- Medical device
- How many people
- 49 participants
- Where
- 1 siteCzechia
- Study dates
- 1 May 2023to 1 Jan 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: surgical patinets admited to the ICU
Who may be able to join
- patient after surgery
- possibility to perform CAM - ICU test (patients with Richmond Agitation-Sedation Scale -2 to +2)
Who cannot join
- eye diseases
- brain injury
- stroke
- epilepsy
- neuromuscular diseases
Trial locations and contacts
1 site in 1 country.
Czechia1 site
St. Anne's University Hospital in Brno
Brno, Czech Republic, 60200
About this study
Official title: Use of Automated Pupillometry for Pain Assessment in ICU Patients With Delirium
Pain assessment in intensive care patients is a constant challenge. Approximately 50% to 80% of patients report pain at rest or during medical or nursing interventions (for example endotracheal suctioning, mobilization and rehabilitation, presence and care of invasive inputs, etc.). Obstacles to pain assessment and management are most often due to interference with communication due to impaired consciousness, airway support and connection to artificial pulmonary ventilation, or the effect of administered medication.
Patients in intensive care are prone to delirium. Delirium can compromise patients' ability to verbalise pain for a variety of reasons (e.g. due to impaired attention, memory, thinking and language barriers). Also, pain and inadequate analgesia are risk factors for delirium.
Read more
Pupillary reflex changes and their identification by automated pupillometry have yielded positive results regarding nociception assessment in adult and pediatric patients and in perioperative and postoperative care. At the same time, the response of these patients to opioid administration was investigated. The aim was to improve their analgesia.
The aim of this study is to find out whether, there is an association between automated pupillometry and selected objective pain measurement scales in The Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) positive patients after surgery.
Read the detailed description
Periodically after 6 hours, the incidence of delirium will be assessed using the CAM ICU questionnaire. Subsequently, the incidence of pain will be assessed using 3 valid scales. The Visual Analogue Scale (VAS), the Behavioral Pain Scale (BPS) and the Critical Care Observational Tool (CPOT) will be used. Finally, automated pupillometry will be measured. The measurement values will be entered in the record sheet. Information about the medications administered and the patient's vital signs will also be recorded.
- Conditions
- Delirium, Pain, Postoperative
- Being tested
- automated pupillometry, questionnaire
- Keywords
- pupillometry, delirium, pain
- Medical subject headings
- Delirium, Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
automated pupillometryDevice
Automated pupillometry every 6 hours
questionnaireDiagnostic test
CAM ICU questionnaire will be used for delirium screening the incidence of pain will be assessed using 3 valid scales. The Visual Analogue Scale (VAS), the Behavioral Pain Scale (BPS) and the Critical Care Observational Tool (CPOT) will be used.
questionnaires will be done the same time as pupillometry
| Study group | Role | What they receive |
|---|---|---|
| surgical ICU patients | All surgical patients on the inpatient ward in the Department of Anesthesiology and Intensive Care Receives: Device: automated pupillometry; Diagnostic Test: questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
pupillometry parameters and objective pain scales
correlation of pupillometry parameters and objective pain scales
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start1 May 2023
- Primary completion31 Dec 2025
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Anne's University Hospital Brno, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ivan Cundrle, St. Anne's University Hospital Brno, Czech Republic
- Investigators
- Patrik Mica, MSc, Principal investigator, St. Anne's University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05811208
- Sponsor's protocol ID
- 11V/2023
- Status last verified
- Apr 2026
- First submitted
- 30 Mar 2023
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Alvarez EA, Parada FJ. Association of Pain During the Evaluation of Delirium in Intensive Care Unit Patients. Front Med (Lausanne). 2021 Aug 24;8:722001. doi: 10.3389/fmed.2021.722001. eCollection 2021. No abstract available.
PubMed 34504855Azevedo-Santos IF, DeSantana JM. Pain measurement techniques: spotlight on mechanically ventilated patients. J Pain Res. 2018 Nov 21;11:2969-2980. doi: 10.2147/JPR.S151169. eCollection 2018.
PubMed 30538536Fischer T, Hosie A, Luckett T, Agar M, Phillips J. Strategies for Pain Assessment in Adult Patients With Delirium: A Scoping Review. J Pain Symptom Manage. 2019 Sep;58(3):487-502.e11. doi: 10.1016/j.jpainsymman.2019.05.020. Epub 2019 Jun 10.
PubMed 31195076Rijkenberg S, van der Voort PH. Can the critical-care pain observation tool (CPOT) be used to assess pain in delirious ICU patients? J Thorac Dis. 2016 May;8(5):E285-7. doi: 10.21037/jtd.2016.03.32. No abstract available.
PubMed 27162683Favre E, Bernini A, Morelli P, Pasquier J, Miroz JP, Abed-Maillard S, Ben-Hamouda N, Oddo M. Neuromonitoring of delirium with quantitative pupillometry in sedated mechanically ventilated critically ill patients. Crit Care. 2020 Feb 24;24(1):66. doi: 10.1186/s13054-020-2796-8.
PubMed 32093710Tosi F, Gatto A, Capossela L, Ferretti S, Mancino A, Curatola A, Chiaretti A, Pulitano S. Role of the pupillometer in the assessment of pain in the sedation of pediatric patients. Eur Rev Med Pharmacol Sci. 2021 Oct;25(20):6349-6355. doi: 10.26355/eurrev_202110_27008.
PubMed 34730216Lukaszewicz AC, Dereu D, Gayat E, Payen D. The relevance of pupillometry for evaluation of analgesia before noxious procedures in the intensive care unit. Anesth Analg. 2015 Jun;120(6):1297-300. doi: 10.1213/ANE.0000000000000609.
PubMed 25993266Mica P, Lukes M, Pokorna A, Hruda J, Olson L, Svoboda M, Cundrle I. Automated pupillometry for detection of delirium in surgical intensive care patients. Front Med (Lausanne). 2026 Jun 4;13:1822468. doi: 10.3389/fmed.2026.1822468. eCollection 2026.
PubMed 42328550
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Automated Pupillometry for Pain Assessment in ICU Patients With Delirium
- ClinicalTrials.gov ID
- NCT05811208
- Acronym / sponsor ID
- 11V/2023
- Conditions
- Delirium, Pain, Postoperative
- Keywords
- pupillometry, delirium, pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- St. Anne's University Hospital Brno, Czech RepublicUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 13 Apr 2023 (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.
Pain assessment in intensive care patients is a constant challenge. Approximately 50% to 80% of patients report pain at rest or during medical or nursing interventions (for example endotracheal suctioning, mobilization and rehabilitation, presence and care of invasive inputs, etc.). Obstacles to pain assessment and management are most often due to interference with communication due to impaired consciousness, airway support and connection to artificial pulmonary ventilation, or the effect of administered medication.
Patients in intensive care are prone to delirium. Delirium can compromise patients' ability to verbalise pain for a variety of reasons (e.g. due to impaired attention, memory, thinking and language barriers). Also, pain and inadequate analgesia are risk factors for delirium.
Pupillary reflex changes and their identification by automated pupillometry have yielded positive results regarding nociception assessment in adult and pediatric patients and in perioperative and postoperative care. At the same time, the response of these patients to opioid administration was investigated. The aim was to improve their analgesia.
The aim of this study is to find out whether, there is an association between automated pupillometry and selected objective pain measurement scales in The Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) positive patients after surgery.
Detailed description
Periodically after 6 hours, the incidence of delirium will be assessed using the CAM ICU questionnaire. Subsequently, the incidence of pain will be assessed using 3 valid scales. The Visual Analogue Scale (VAS), the Behavioral Pain Scale (BPS) and the Critical Care Observational Tool (CPOT) will be used. Finally, automated pupillometry will be measured. The measurement values will be entered in the record sheet. Information about the medications administered and the patient's vital signs will also be recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| surgical ICU patients | – | Device: automated pupillometry, Diagnostic Test: questionnaireAll surgical patients on the inpatient ward in the Department of Anesthesiology and Intensive Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- surgical patinets admited to the ICU
Key inclusion criteria (2 listed)
- patient after surgery
- possibility to perform CAM - ICU test (patients with Richmond Agitation-Sedation Scale -2 to +2)
Key exclusion criteria (5 listed)
- eye diseases
- brain injury
- stroke
- epilepsy
- neuromuscular diseases
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 |
|---|---|---|
| automated pupillometryAutomated pupillometry every 6 hours | Device | surgical ICU patients |
| questionnaireCAM ICU questionnaire will be used for delirium screening the incidence of pain will be assessed using 3 valid scales. The Visual Analogue Scale (VAS), the Behavioral Pain Scale (BPS) and the Critical Care Observational Tool (CPOT) will be used. questionnaires will be done the same time as pupillometry | Diagnostic test | surgical ICU patients |
Primary outcome
pupillometry parameters and objective pain scales
Time frame: up to 4 weeks
correlation of pupillometry parameters and objective pain scales
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 27 Apr 2026.
- Background: PubMed 34504855Alvarez EA, Parada FJ. Association of Pain During the Evaluation of Delirium in Intensive Care Unit Patients. Front Med (Lausanne). 2021 Aug 24;8:722001. doi: 10.3389/fmed.2021.722001. eCollection 2021. No abstract available.
- Background: PubMed 30538536Azevedo-Santos IF, DeSantana JM. Pain measurement techniques: spotlight on mechanically ventilated patients. J Pain Res. 2018 Nov 21;11:2969-2980. doi: 10.2147/JPR.S151169. eCollection 2018.
- Background: PubMed 31195076Fischer T, Hosie A, Luckett T, Agar M, Phillips J. Strategies for Pain Assessment in Adult Patients With Delirium: A Scoping Review. J Pain Symptom Manage. 2019 Sep;58(3):487-502.e11. doi: 10.1016/j.jpainsymman.2019.05.020. Epub 2019 Jun 10.
- Background: PubMed 27162683Rijkenberg S, van der Voort PH. Can the critical-care pain observation tool (CPOT) be used to assess pain in delirious ICU patients? J Thorac Dis. 2016 May;8(5):E285-7. doi: 10.21037/jtd.2016.03.32. No abstract available.
- Background: PubMed 32093710Favre E, Bernini A, Morelli P, Pasquier J, Miroz JP, Abed-Maillard S, Ben-Hamouda N, Oddo M. Neuromonitoring of delirium with quantitative pupillometry in sedated mechanically ventilated critically ill patients. Crit Care. 2020 Feb 24;24(1):66. doi: 10.1186/s13054-020-2796-8.
- Background: PubMed 34730216Tosi F, Gatto A, Capossela L, Ferretti S, Mancino A, Curatola A, Chiaretti A, Pulitano S. Role of the pupillometer in the assessment of pain in the sedation of pediatric patients. Eur Rev Med Pharmacol Sci. 2021 Oct;25(20):6349-6355. doi: 10.26355/eurrev_202110_27008.
- Background: PubMed 25993266Lukaszewicz AC, Dereu D, Gayat E, Payen D. The relevance of pupillometry for evaluation of analgesia before noxious procedures in the intensive care unit. Anesth Analg. 2015 Jun;120(6):1297-300. doi: 10.1213/ANE.0000000000000609.
- Derived from this study: PubMed 42328550Mica P, Lukes M, Pokorna A, Hruda J, Olson L, Svoboda M, Cundrle I. Automated pupillometry for detection of delirium in surgical intensive care patients. Front Med (Lausanne). 2026 Jun 4;13:1822468. doi: 10.3389/fmed.2026.1822468. eCollection 2026.
- 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.
Patrik Mica, MSc principal investigator
St. Anne's University Hospital
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 Pain, Postoperative, run by St. Anne's University Hospital Brno, Czech Republic at 1 site in Czechia.
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 2 inclusion and 5 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 27 Apr 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 Czechia. 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?
pupillometry parameters and objective pain scales (time frame: up to 4 weeks). 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 NCT05811208, which also lists 8 linked publications.
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 27 Apr 2026.