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

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ClinicalTrials.gov Identifier: NCT02916004
Recruitment Status : Recruiting
First Posted : September 27, 2016
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
Davina Wildemeersch, 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.)


Condition or disease Intervention/treatment Phase
Critical Illness Device: Measurement of NFR and PDR Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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.
Study Start Date : October 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Test the feasibility of a objective pain evaluation tool; the nociception flexion reflex (NFR) [ Time Frame: 10 seconds after nociceptive stimulation ]
  2. Test the feasibility of a objective pain evaluation tool; the pupillary dilatation reflex (PDR) [ Time Frame: 10 seconds after nociceptive stimulation ]

Secondary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02916004


Contacts
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Contact: Davina Wildemeersch, MD 38215891 ext 0032 davina.wildemeersch@uza.be
Contact: Guy Hans, MD, PhD 38213586 ext 0032

Locations
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Belgium
University hospital Antwerp Recruiting
Edegem, Antwerpen, Belgium, 2650
Contact: Davina Wildemeersch, MD    38215891 ext 0032    davina.wildemeersch@uza.be   
Principal Investigator: Guy Hans, MD, PhD         
Principal Investigator: Philippe Jorens, MD, PhD         
Principal Investigator: Davina Wildemeersch, MD         
Sponsors and Collaborators
University Hospital, Antwerp
Investigators
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Principal Investigator: Davina Wildemeersch, MD University Hospital, Antwerp

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Responsible Party: Davina Wildemeersch, MD, University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT02916004     History of Changes
Other Study ID Numbers: 16/33/334
First Posted: September 27, 2016    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019
Keywords provided by Davina Wildemeersch, University Hospital, Antwerp:
Analgesia
Pain measurement
Nociception
Electromyography
Electrical stimulation
Pupillometry
Critical care
Sedation
Additional relevant MeSH terms:
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Mydriasis
Critical Illness
Disease Attributes
Pathologic Processes
Pupil Disorders
Eye Diseases