Use of Pupillometry for Pain Assessment in ICU Patients W... | NCT05811208

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

NCT05811208

Sponsor

St. Anne's University Hospital Brno, Czech Republic

Status

Completed

Last Update Posted

Apr 27, 2026Actual

Enrollment

49Actual

Phase

Not provided

Conditions

Delirium
Pain, Postoperative

Interventions

automated pupillometry
questionnaire

Countries

Czechia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2023Actual

Primary Completion Date

Dec 31, 2025Actual

Completion Date

Jan 1, 2026Actual

First Submitted Date

Mar 30, 2023

First Submission Date that Met QC Criteria

Apr 12, 2023

First Posted Date

Apr 13, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 22, 2026

Last Update Posted Date

Apr 27, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ivan Cundrle, Clinical Professor, St. Anne's University Hospital Brno, Czech RepublicPrincipal Investigator

Lead Sponsor

St. Anne's University Hospital Brno, Czech RepublicOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

49Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
automated pupillometry	Device	Automated pupillometry every 6 hours	surgical ICU patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pupillometry parameters and objective pain scales	correlation of pupillometry parameters and objective pain scales	up to 4 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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
stroke
epilepsy
neuromuscular diseases

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

surgical patinets admited to the ICU

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Patrik Mica, MSc	St. Anne's University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. Anne's University Hospital in Brno		Brno	Czech Republic	60200	Czechia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34504855	Background	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.
30538536	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.

ID	Term
D003221	Confusion
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

ID	Term
D009460	Neurologic Examination
D010808	Physical Examination
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

ID	Term
D003693	Delirium
D010149	Pain, Postoperative
D010146	Pain