An interventional study of Measurement of NFR and PDR in Critical Illness, sponsored by University Hospital, Antwerp. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-15.
Sponsored by University Hospital, Antwerp · Not applicable, Interventional, and Diagnostic
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.)
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.
1,780 studies on the registry are indexed under Critical Illness; 442 are open to participants now.
This study's enrollment of 40 is below the median of 90 across 926 interventional studies indexed under Critical Illness.
Browse Critical Illness studies →University Hospital, Antwerp is the lead sponsor of 243 studies on the registry; 66 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Routine assessment of pain by attending nurse
Time frame: 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
Time frame: In period of routine two hourly check up by nurse
Ran from Sep 2016 to primary completion in Nov 2017, 14 months.
Of 400 non-industry interventional studies with no phase under Critical Illness, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 40. This study's 14 months is below that.
Counting every sponsor, half of 404 studies reached it within 21 months; a quarter within 12 and three quarters within 40.
Critical Illness covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
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This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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