Critical IllnessNCT02916004
The Use of Nociception Flexion Reflex and Pupillary Dilatation Reflex in ICU Patients.
A study testing Measurement of NFR and PDR in people with Critical Illness, run by University Hospital, Antwerp at 1 site in Belgium.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- Measurement of NFR and PDR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 26 Sep 2016to 14 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.)
Read the 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.
- Conditions
- Critical Illness
- Being tested
- Measurement of NFR and PDR
- Keywords
- Analgesia, Pain measurement, Nociception, Electromyography, Electrical stimulation, Pupillometry, Critical care, Sedation
- Medical subject headings
- Critical Illness, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of NFR and PDRDevice
Feasibility testing of NFR and PDR in sedated, ventilated patients. Comparison of NFR and PDR with standard routine care of pain assessment
| Study group | Role | What they receive |
|---|---|---|
| Measurement of NFR and PDR | Other | Diagnostic intervention: excite NFR and PDR in comparison to behavior pain scale (BPS) Receives: Device: Measurement of NFR and PDR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test the feasibility of a objective pain evaluation tool; the nociception flexion reflex (NFR)
Measured: 10 seconds after nociceptive stimulation
Test the feasibility of a objective pain evaluation tool; the pupillary dilatation reflex (PDR)
Measured: 10 seconds after nociceptive stimulation
Secondary outcomes (2)
Comparison NFR and the standard of care pain assessment (behavior pain scale)
Routine assessment of pain by attending nurse
Measured: 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
Measured: In period of routine two hourly check up by nurse
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2016 (estimated)
- Study start26 Sep 2016
- Primary completion30 Nov 2017
- Study completion14 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Davina Wildemeersch, University Hospital, Antwerp
- Investigators
- Davina Wildemeersch, MD, Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02916004
- Sponsor's protocol ID
- 16/33/334
- Status last verified
- May 2023
- First submitted
- 15 Sep 2016
- Last updated
- 15 May 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02916004
- Acronym / sponsor ID
- 16/33/334
- Conditions
- Critical Illness
- Keywords
- Analgesia, Pain measurement, Nociception, Electromyography, Electrical stimulation, Pupillometry, Critical care, Sedation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- 26 Sep 2016 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 14 Jul 2018 (actual)
- First posted
- 27 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Measurement of NFR and PDR | Other | Device: Measurement of NFR and PDRDiagnostic intervention: excite NFR and PDR in comparison to behavior pain scale (BPS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement of NFR and PDRFeasibility testing of NFR and PDR in sedated, ventilated patients. Comparison of NFR and PDR with standard routine care of pain assessment | Device | Measurement of NFR and PDR |
Primary outcome
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
2 secondary outcomes
Comparison NFR and the standard of care pain assessment (behavior pain scale)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Davina Wildemeersch, MD principal investigator
University Hospital, Antwerp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measurement of NFR and PDR in people with Critical Illness, run by University Hospital, Antwerp at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test the feasibility of a objective pain evaluation tool; the nociception flexion reflex (NFR) (time frame: 10 seconds after nociceptive stimulation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2023.