Use of Pupillometry for Pain Assessment in ICU Patients With Delirium

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05811208
• Other study ID #: 11V/2023
• Status: Recruiting
• Start date: May 1, 2023
• Est. completion date: January 1, 2026

Study information

• Verified date: November 2023
• Source: St. Anne's University Hospital Brno, Czech Republic
• Contact: Ivan Cundrle, MD, PhD
• Phone: 00420543183533
• Email: ivan.cundrle[@]fnusa.cz
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 1, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Pain, Postoperative

Intervention

Device:
• automated pupillometry
Automated pupillometry every 6 hours

Diagnostic Test:
• questionnaire
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

Locations

Country	Name	City	State
Czechia	St. Anne's University Hospital in Brno	Brno	Czech Republic

Sponsors (1)

Lead Sponsor	Collaborator
St. Anne's University Hospital Brno, Czech Republic

Country where clinical trial is conducted

Czechia, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pupillometry parameters and objective pain scales	correlation of pupillometry parameters and objective pain scales	up to 4 weeks