Use of Pupillometry for Pain Assessment in ICU Patients with Delirium

Recruiting

• Conditions: Pain, Postoperative; Delirium
• Interventions: Device: automated pupillometry; Diagnostic Test: questionnaire

• Registration Number: NCT05811208
• Lead Sponsor: St. Anne's University Hospital Brno, Czech Republic

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.

Study Timeline

• Study First Submitted: 2023-03-30
• Study First Submitted QC: 2023-04-12
• Study First Posted: 2023-04-13
• Study Start: 2023-05-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-17
• Last Update Posted: 2024-11-20
• Primary Completion: 2025-12-31
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
surgical ICU patients	automated pupillometry	All surgical patients on the inpatient ward in the Department of Anesthesiology and Intensive Care
surgical ICU patients	questionnaire	All surgical patients on the inpatient ward in the Department of Anesthesiology and Intensive Care

Primary Outcome Measures

Name	Time	Method
pupillometry parameters and objective pain scales	up to 4 weeks	correlation of pupillometry parameters and objective pain scales

Trial Locations

Locations (1)

St. Anne's University Hospital in Brno; 🇨🇿 Brno, Czech republic, Czechia