Use of Pupillometry for Pain Assessment in ICU Patients With Delirium

Status Recruiting

Clinical 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.). 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05811208
Study type	Observational
Source	St. Anne's University Hospital Brno, Czech Republic
Contact	Ivan Cundrle, MD, PhD
Phone	00420543183533
Email	ivan.cundrle@fnusa.cz
Status	Recruiting
Phase
Start date	May 1, 2023
Completion date	January 1, 2026

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.