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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-26

Study Completion Date

2018-07-14

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.)

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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.

Conditions

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Critical Illness

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Measurement of NFR and PDR

Diagnostic intervention: excite NFR and PDR in comparison to behavior pain scale (BPS)

Group Type OTHER

Measurement of NFR and PDR

Intervention Type DEVICE

Feasibility testing of NFR and PDR in sedated, ventilated patients. Comparison of NFR and PDR with standard routine care of pain assessment

Interventions

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Measurement of NFR and PDR

Feasibility testing of NFR and PDR in sedated, ventilated patients. Comparison of NFR and PDR with standard routine care of pain assessment

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No