The Use of Nociception Flexion Reflex and Pupillary Dilatation Reflex in ICU Patients.

Not Applicable

Completed

• Conditions: Critical Illness
• Interventions: Device: Measurement of NFR and PDR

• Registration Number: NCT02916004
• Lead Sponsor: University Hospital, Antwerp

Brief Summary

The aim of the study was to describe the feasibility of the nociception flexion reflex and the pupillary dilatation reflex as objective pain assessment tools in the Intensive Care Unit (ICU). Furthermore to describe the relationship between the responses and the standard of care pain evaluation in the critically ill sedated patients.

Patients were under propofol / remifentanil or propofol / sufentanil sedation protocol during measurements in a stair-case increasing intensity model of standardized stimulations. (Stimulation intensity are similar to the stimulations of neuromuscular blocking agents monitoring.)

Detailed Description

Pupillary dilatation reflex: tetanic stimulations at the nervus medianus were performed starting form 10 milliamperes (mA) up to 60mA. Pupillary diameter was measured before, during and after stimulation.

Nociception flexion reflex: tetanic stimulations at the nervus suralis were performed starting form 0.5mA in increasing steps via an automated RIII (NFR) threshold tracking model.

Study Timeline

• Study First Submitted: 2016-09-15
• Study First Submitted QC: 2016-09-23
• Study Start: 2016-09-26
• Study First Posted: 2016-09-27
• Primary Completion: 2017-11-30
• Study Completion: 2018-07-14
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-11
• Last Update Posted: 2023-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 18 years of age or older
• Critically ill with necessity to mechanic ventilation
• Hospitalized at the ICU of our institution
• Started sedation protocol (propofol/remifentanil or propofol/sufentanil)
• Approved informed consent by family member or relative.

Exclusion Criteria

• Known eye deformity or extented ophthalmologic surgery in history
• Severe traumatic brain injury of fulminant stroke
• Known (poly)neuropathy of complicated diabetes
• Need for continuously curarization
• Hemodynamic instability

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Measurement of NFR and PDR	Measurement of NFR and PDR	Diagnostic intervention: excite NFR and PDR in comparison to behavior pain scale (BPS)

Primary Outcome Measures

Name	Time	Method
Test the feasibility of a objective pain evaluation tool; the nociception flexion reflex (NFR)	10 seconds after nociceptive stimulation
Test the feasibility of a objective pain evaluation tool; the pupillary dilatation reflex (PDR)	10 seconds after nociceptive stimulation

Secondary Outcome Measures

Name	Time	Method
Comparison NFR and the standard of care pain assessment (behavior pain scale)	In period of routine two hourly check up by nurse	Routine assessment of pain by attending nurse
Comparison PDR and the standard of care pain assessment (behavior pain scale)	In period of routine two hourly check up by nurse	Routine assessment of pain by attending nurse

Trial Locations

Locations (1)

University hospital Antwerp; 🇧🇪 Edegem, Antwerpen, Belgium