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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 : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
Davina Wildemeersch, University Hospital, Antwerp

Tracking Information
First Submitted Date  ICMJE September 15, 2016
First Posted Date  ICMJE September 27, 2016
Last Update Posted Date March 20, 2019
Study Start Date  ICMJE October 2016
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2016)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02916004 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2016)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Use of Nociception Flexion Reflex and Pupillary Dilatation Reflex in ICU Patients.
Official Title  ICMJE 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Critical Illness
Intervention  ICMJE 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
Study Arms  ICMJE Measurement of NFR and PDR
Diagnostic intervention: excite NFR and PDR in comparison to behavior pain scale (BPS)
Intervention: Device: Measurement of NFR and PDR
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 23, 2016)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Davina Wildemeersch, MD 38215891 ext 0032 davina.wildemeersch@uza.be
Contact: Guy Hans, MD, PhD 38213586 ext 0032
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02916004
Other Study ID Numbers  ICMJE 16/33/334
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Davina Wildemeersch, University Hospital, Antwerp
Study Sponsor  ICMJE University Hospital, Antwerp
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Davina Wildemeersch, MD University Hospital, Antwerp
PRS Account University Hospital, Antwerp
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP