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Use of Pupillometry for Pain Assessment in ICU Patients with Delirium

Use of Automated Pupillometry for Pain Assessment in ICU Patients with Delirium

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05811208
Enrollment
50
Registered
2023-04-13
Start date
2023-05-01
Completion date
2026-01-01
Last updated
2024-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium, Pain, Postoperative

Keywords

pupillometry, delirium, pain

Brief 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.). 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.

Interventions

Automated pupillometry every 6 hours

DIAGNOSTIC_TESTquestionnaire

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

Sponsors

St. Anne's University Hospital Brno, Czech Republic
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* patient after surgery * possibility to perform CAM - ICU test (patients with Richmond Agitation-Sedation Scale -2 to +2)

Exclusion criteria

* eye diseases * brain injury * stroke * epilepsy * neuromuscular diseases

Design outcomes

Primary

MeasureTime frameDescription
pupillometry parameters and objective pain scalesup to 4 weekscorrelation of pupillometry parameters and objective pain scales

Countries

Czechia

Contacts

Primary ContactIvan Cundrle, MD, PhD
ivan.cundrle@fnusa.cz00420543183533
Backup ContactPatrik Mica, MSc
patrik.mica@fnusa.cz00420543182559

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026