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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Responsiveness to Noxious Stimuli in Ventilated Intensive Care Unit (ICU) Patients With Propofol / Remifentanil Sedation Protocol by Using the Nociception Flexion Reflex (RIII Reflex) and the Pupillary Dilatation Reflex.

Conditions
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Critical Illness

Intervention / Treatment
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* Device: Measurement of NFR and PDR


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Measurement of NFR and PDR<br>Diagnostic intervention: excite NFR and PDR in comparison to behavior pain scale (BPS) | Device: Measurement of NFR and PDR<br>* Feasibility testing of NFR and PDR in sedated, ventilated patients. Comparison of NFR and PDR with standard routine care of pain assessment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison NFR and the standard of care pain assessment (behavior pain scale) | Routine assessment of pain by attending nurse | In period of routine two hourly check up by nurse | 
| Comparison PDR and the standard of care pain assessment (behavior pain scale) | Routine assessment of pain by attending nurse | In period of routine two hourly check up by nurse | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Critical care, Pupillometry, Analgesia, Pain measurement, Nociception, Electromyography, Electrical stimulation, Sedation