NCT02916004

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.)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2016

Completed
11 days until next milestone

Study Start

First participant enrolled

September 26, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 27, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 14, 2018

Completed
Last Updated

May 15, 2023

Status Verified

May 1, 2023

Enrollment Period

1.2 years

First QC Date

September 15, 2016

Last Update Submit

May 11, 2023

Conditions

Critical Illness

Keywords

AnalgesiaPain measurementNociceptionElectromyographyElectrical stimulationPupillometryCritical careSedation

Outcome Measures

Primary Outcomes (2)

  • Test the feasibility of a objective pain evaluation tool; the nociception flexion reflex (NFR)

    10 seconds after nociceptive stimulation

  • Test the feasibility of a objective pain evaluation tool; the pupillary dilatation reflex (PDR)

    10 seconds after nociceptive stimulation

Secondary Outcomes (2)

  • Comparison NFR and the standard of care pain assessment (behavior pain scale)

    In period of routine two hourly check up by nurse

  • Comparison PDR and the standard of care pain assessment (behavior pain scale)

    In period of routine two hourly check up by nurse

Study Arms (1)

Measurement of NFR and PDR

OTHER

Diagnostic intervention: excite NFR and PDR in comparison to behavior pain scale (BPS)

Device: Measurement of NFR and PDR

Interventions

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

Measurement of NFR and PDR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital Antwerp

Edegem, Antwerpen, 2650, Belgium

Location

MeSH Terms

Conditions

Critical IllnessAgnosia

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and Symptoms

Study Officials

  • Davina Wildemeersch, MD

    University Hospital, Antwerp

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 15, 2016

First Posted

September 27, 2016

Study Start

September 26, 2016

Primary Completion

November 30, 2017

Study Completion

July 14, 2018

Last Updated

May 15, 2023

Record last verified: 2023-05

Locations

BE(1)