Guiding Sufentanil Administration With Skin Conductance in Mechanically Ventilated Intensive Care Patients

Sponsor
Erasme University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04696016
Collaborator
(none)
30
2
5.9

Study Details

Study Description

Brief Summary

Opioid administration in mechanically ventilated patients in the intensive care unit (ICU) is essential to maintaining patient respiratory and hemodynamic stability. Mechanical ventilation is a persistently nociceptive event that can continuously causes discomfort in the trachealy intubated patient. This can lead to patient-ventilator dyssynchrony, tachycardia, hypertension, and their associated complications. Opioids blunt respiratory drive, which facilitates mechanical ventilation, and decrease the sympathetic response to nociception. However, excessive opiate administration is associated with many adverse events, including respiratory depression, delirium, ileus, nausea, and vomiting. Currently, the standard administration in our institution of sufentanil, a potent opiate, consists of continuous infusions of 0.15µg/kg/h to 0.3µg/kg/h.

Mechanically ventilated patients are unable to speak and are often sedated. This greatly impacts the patient's capacity to communicate pain. The use of a nociceptive monitor may be a possible solution. Skin conductance monitoring (Pain Monitor, Med-Storm, Norway), measures the peaks per second of electrical conduction. This non hemodynamic monitor uses skin conduction as a surrogate to nociception (i.e., the patient's unconscious response to a noxious stimulus). It may consequently guide opioid administration in ICU patients towards and avoid the consequences of excessive or inadequate antinociception.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Skin conductance guided antinociception
  • Procedure: Standard care antinociception
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Guiding Sufentanil Administration With Skin Conductance in Mechanically Ventilated Intensive Care Patients
Anticipated Study Start Date :
Feb 1, 2021
Anticipated Primary Completion Date :
Jul 30, 2021
Anticipated Study Completion Date :
Jul 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Skin conductance guided

Sufentanil is titrated by the intensive care team to maintain skin conductance in target

Procedure: Skin conductance guided antinociception
The value of skin conductance guides the titration of sufentanil

Active Comparator: Standard care

Sufentanil is titrated at the discretion of the intensivist

Procedure: Standard care antinociception
The intensive care team titrates antinociception based on their standard approach (using a clinical approach by assessing blood pressure, heart rate, and ventilator dyssynchrony).

Outcome Measures

Primary Outcome Measures

  1. Concentration of sufentanil requirements [one day to 2 weeks]

    Sufentanil requirements (µg/kg/h)

Secondary Outcome Measures

  1. Concentration of propofol requirements [one day to 2 weeks]

    Propofol requirements (mg/kg/h)

  2. Concentration of noradrenaline requirements (concentration of) [one day to 2 weeks]

    noradrenaline requirements (µg/kg/min)

  3. Intubation time [one day to 2 weeks]

    Total time of mechanical ventilation (intubated)

  4. Composite post extubation related complications [one day to 2 weeks]

    post extubation opioid related complications (e.g., delirium, vomiting, nausea, ileus, respiratory acidosis, hypoxemia, reintubation).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Adult patient admitted to the ICU requiring endotracheal intubation, antinociception, and sedation
Exclusion Criteria:
  • Traumatic brain injury

  • use of ketamine, dexmedetomidine, or clonidine

  • pregnancy

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Erasme University Hospital

Investigators

  • Principal Investigator: Fabio Taccone, Université Libre de Bruxelles

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Erasme University Hospital
ClinicalTrials.gov Identifier:
NCT04696016
Other Study ID Numbers:
  • P2020/402 / B4062020000124
First Posted:
Jan 6, 2021
Last Update Posted:
Feb 3, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 3, 2021