Use of Pupillometry for Pain Assessment in ICU Patients With Delirium

NCT05811208 | Completed

• 1 other identifier: 11V/2023
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium; Pain, Postoperative

Keywords

pupillometry; delirium; pain

Outcome Measures

Primary Outcomes (1)

• pupillometry parameters and objective pain scales

  correlation of pupillometry parameters and objective pain scales

  up to 4 weeks

Study Arms (1)

surgical ICU patients

All surgical patients on the inpatient ward in the Department of Anesthesiology and Intensive Care

Device: automated pupillometry; Diagnostic Test: questionnaire

Interventions

automated pupillometry DEVICE

Automated pupillometry every 6 hours

surgical ICU patients

questionnaire DIAGNOSTIC_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

surgical ICU patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

surgical patinets admited to the ICU

You may qualify if:

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

You may not qualify if:

• eye diseases
• brain injury
• stroke
• epilepsy
• neuromuscular diseases

Sponsors & Collaborators

• St. Anne's University Hospital Brno, Czech Republic: lead

Study Sites (1)

St. Anne's University Hospital in Brno

Brno, Czech Republic, 60200, Czechia

Location

Related Publications (7)

• 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.

  PMID: 34504855 BACKGROUND

• Azevedo-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.

  PMID: 30538536 BACKGROUND

• Fischer 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.

  PMID: 31195076 BACKGROUND

• Rijkenberg 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.

  PMID: 27162683 BACKGROUND

• Favre 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.

  PMID: 32093710 BACKGROUND

• Tosi 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.

  PMID: 34730216 BACKGROUND

• Lukaszewicz 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.

  PMID: 25993266 BACKGROUND

MeSH Terms

Conditions

Delirium; Pain, Postoperative; Pain

Interventions

Pain Measurement

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Neurologic Examination; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Patrik Mica, MSc

  St. Anne's University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: April 13, 2023
• Study Start: May 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: January 1, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

CZ (1)