CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 49 enrolled
Drug / intervention
automated pupillometry +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05811208
NCT05811208N/ACompleted

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

St. Anne's University Hospital Brno, Czech Republic·observational·Posted Apr 13, 2023·Updated Apr 27, 2026

In Brief

An observational study evaluating automated pupillometry and questionnaire for Delirium and Pain, Postoperative. Completed, enrolled 49 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesCzechia
Collaborators--

Timeline

N/ACompletedFinished
202420252026
First PostedApr 13, 2023
Enrollment StartMay 1, 2023
Primary CompletionDec 31, 2025
Study CompletionJan 1, 2026
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 3.2 years ago

Interventions

automated pupillometrydevice

Automated pupillometry every 6 hours

questionnaireother

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