Back to resultsThe Use of Nociception Flexion Reflex and Pupillary Dilatation Reflex in ICU Patients.
Primary Purpose
Critical Illness
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Measurement of NFR and PDR
Sponsored by
About this trial
This is an interventional diagnostic trial for Critical Illness focused on measuring Analgesia, Pain measurement, Nociception, Electromyography, Electrical stimulation, Pupillometry, Critical care, Sedation
Eligibility 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
Sites / Locations
- University hospital Antwerp
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Measurement of NFR and PDR
Arm Description
Diagnostic intervention: excite NFR and PDR in comparison to behavior pain scale (BPS)
Outcomes
Primary Outcome Measures
Test the feasibility of a objective pain evaluation tool; the nociception flexion reflex (NFR)
Test the feasibility of a objective pain evaluation tool; the pupillary dilatation reflex (PDR)
Secondary Outcome Measures
Comparison NFR and the standard of care pain assessment (behavior pain scale)
Routine assessment of pain by attending nurse
Comparison PDR and the standard of care pain assessment (behavior pain scale)
Routine assessment of pain by attending nurse
Full Information
NCT ID
NCT02916004
First Posted
September 15, 2016
Last Updated
May 11, 2023
Sponsor
University Hospital, Antwerp
1. Study Identification
Unique Protocol Identification Number
NCT02916004
Brief Title
The Use of Nociception Flexion Reflex and Pupillary Dilatation Reflex in ICU Patients.
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 Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
September 26, 2016 (Actual)
Primary Completion Date
November 30, 2017 (Actual)
Study Completion Date
July 14, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Antwerp
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.)
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness
Keywords
Analgesia, Pain measurement, Nociception, Electromyography, Electrical stimulation, Pupillometry, Critical care, Sedation
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Measurement of NFR and PDR
Arm Type
Other
Arm Description
Diagnostic intervention: excite NFR and PDR in comparison to behavior pain scale (BPS)
Intervention Type
Device
Intervention Name(s)
Measurement of NFR and PDR
Intervention Description
Feasibility testing of NFR and PDR in sedated, ventilated patients. Comparison of NFR and PDR with standard routine care of pain assessment
Primary Outcome Measure Information:
Title
Test the feasibility of a objective pain evaluation tool; the nociception flexion reflex (NFR)
Time Frame
10 seconds after nociceptive stimulation
Title
Test the feasibility of a objective pain evaluation tool; the pupillary dilatation reflex (PDR)
Time Frame
10 seconds after nociceptive stimulation
Secondary Outcome Measure Information:
Title
Comparison NFR and the standard of care pain assessment (behavior pain scale)
Description
Routine assessment of pain by attending nurse
Time Frame
In period of routine two hourly check up by nurse
Title
Comparison PDR and the standard of care pain assessment (behavior pain scale)
Description
Routine assessment of pain by attending nurse
Time Frame
In period of routine two hourly check up by nurse
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Davina Wildemeersch, MD
Organizational Affiliation
University Hospital, Antwerp
Official's Role
Principal Investigator
Facility Information:
Facility Name
University hospital Antwerp
City
Edegem
State/Province
Antwerpen
ZIP/Postal Code
2650
Country
Belgium
12. IPD Sharing Statement
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The Use of Nociception Flexion Reflex and Pupillary Dilatation Reflex in ICU Patients.
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