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 : January 6, 2020
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|
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 (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 2020|
|Estimated Study Completion Date :||March 2021|
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
- Test the feasibility of a objective pain evaluation tool; the nociception flexion reflex (NFR) [ Time Frame: 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 ]
- 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
- 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
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
|Contact: Davina Wildemeersch, MD||38215891 ext firstname.lastname@example.org|
|Contact: Guy Hans, MD, PhD||38213586 ext 0032|
|University hospital Antwerp||Recruiting|
|Edegem, Antwerpen, Belgium, 2650|
|Contact: Davina Wildemeersch, MD 38215891 ext 0032 email@example.com|
|Principal Investigator: Guy Hans, MD, PhD|
|Principal Investigator: Philippe Jorens, MD, PhD|
|Principal Investigator: Davina Wildemeersch, MD|
|Principal Investigator:||Davina Wildemeersch, MD||University Hospital, Antwerp|