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Clinical Trials/NCT05811208
NCT05811208
Recruiting
Not Applicable

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

St. Anne's University Hospital Brno, Czech Republic1 site in 1 country50 target enrollmentMay 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Delirium
Sponsor
St. Anne's University Hospital Brno, Czech Republic
Enrollment
50
Locations
1
Primary Endpoint
pupillometry parameters and objective pain scales
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2023
End Date
January 1, 2026
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
St. Anne's University Hospital Brno, Czech Republic
Responsible Party
Principal Investigator
Principal Investigator

Ivan Cundrle

Clinical Professor

St. Anne's University Hospital Brno, Czech Republic

Eligibility Criteria

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
  • neuromuscular diseases

Outcomes

Primary Outcomes

pupillometry parameters and objective pain scales

Time Frame: up to 4 weeks

correlation of pupillometry parameters and objective pain scales

Study Sites (1)

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