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

May 11, 2023 updated by: Davina Wildemeersch, University Hospital, Antwerp

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.

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.)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Guy Hans, MD, PhD
  • Phone Number: 0032 38213586

Study Locations

  • Belgium
    • Antwerpen
      • Edegem, Antwerpen, Belgium, 2650
        • University Hospital Antwerp

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Measurement of NFR and PDR
Diagnostic intervention: excite NFR and PDR in comparison to behavior pain scale (BPS)
Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Test the feasibility of a objective pain evaluation tool; the nociception flexion reflex (NFR)
Time Frame: 10 seconds after nociceptive stimulation
10 seconds after nociceptive stimulation
Test the feasibility of a objective pain evaluation tool; the pupillary dilatation reflex (PDR)
Time Frame: 10 seconds after nociceptive stimulation
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)
Time Frame: In period of routine two hourly check up by nurse
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)
Time Frame: In period of routine two hourly check up by nurse
Routine assessment of pain by attending nurse
In period of routine two hourly check up by nurse

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Antwerp

Investigators

  • Principal Investigator: Davina Wildemeersch, MD, University Hospital, Antwerp

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 26, 2016

Primary Completion (Actual)

November 30, 2017

Study Completion (Actual)

July 14, 2018

Study Registration Dates

First Submitted

September 15, 2016

First Submitted That Met QC Criteria

September 23, 2016

First Posted (Estimate)

September 27, 2016

Study Record Updates

Last Update Posted (Actual)

May 15, 2023

Last Update Submitted That Met QC Criteria

May 11, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16/33/334

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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