Postoperative Residual Paralysis After Cardiac Surgery
Primary Purpose
Postoperative Residual Curarization
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
peripheral neuromuscular monitor
Sponsored by
About this trial
This is an interventional diagnostic trial for Postoperative Residual Curarization focused on measuring neuromuscular blockade, neuromuscular monitoring
Eligibility Criteria
Inclusion Criteria:
- patients admitted to the ICU after elective cardiac surgery
Exclusion Criteria:
- emergency cardiac surgery
Sites / Locations
- OLV Hospital
Outcomes
Primary Outcome Measures
postoperative residual curarisation
mean train-of-four <90% as measured by neuromuscular blockade monitoring
Secondary Outcome Measures
Full Information
NCT ID
NCT03291184
First Posted
September 19, 2017
Last Updated
April 9, 2018
Sponsor
Onze Lieve Vrouw Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03291184
Brief Title
Postoperative Residual Paralysis After Cardiac Surgery
Official Title
Is Postoperative Residual Curarisation Still an Issue at the Moment of Weaning of the ICU Patient Following Cardiac Surgery?
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
September 4, 2017 (Actual)
Primary Completion Date
January 2, 2018 (Actual)
Study Completion Date
March 8, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Onze Lieve Vrouw Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main objective of this study is to describe the incidence of postoperative residual paralysis (mean train-of-four <90%) when weaning from the ventilator in patients admitted to the Intensive Care Unit (ICU) after elective cardiac surgery. Train-of-four monitoring is a widely used term for the peripheral nerve stimulation used in neuromuscular blockade monitoring. When the patient is ready for weaning from the ventilator, an ICU doctor will perform a measurement of the train-of-four at the thumb with a neuromuscular transmission monitor. Every value below 90% will be considered as residual paralysis and treated appropriately by means of a reversal agent.
Detailed Description
Postoperatively, in the ICU, readiness-for-weaning is based on ICU doctor-nurse-driven institutional weaning guidelines: 6 hours after arrival in the ICU, a patient who is normothermic, hemodynamically stable, has normal blood gasses and absence of residual bleeding. The ICU nurse caring for the patient will start weaning the patient from the ventilator, following these departmental guidelines.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Residual Curarization
Keywords
neuromuscular blockade, neuromuscular monitoring
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patients admitted to the ICU after elective cardiac surgery and ready for weaning from the ventilator.
Masking
ParticipantInvestigator
Masking Description
The participant will still be under sedation at the moment of measuring neuromuscular blockade. The care provider will perform measurements, while the investigator is blinded.
Allocation
N/A
Enrollment
93 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
peripheral neuromuscular monitor
Intervention Description
Residual paralysis can only be measured by neuromuscular transmission monitoring of a peripheral nerve, typically the ulnar nerve innervating the adductor pollicis muscle.
Primary Outcome Measure Information:
Title
postoperative residual curarisation
Description
mean train-of-four <90% as measured by neuromuscular blockade monitoring
Time Frame
6 hours after arrival in the ICU
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients admitted to the ICU after elective cardiac surgery
Exclusion Criteria:
emergency cardiac surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GUY CAMMU
Organizational Affiliation
Onze-Lieve-Vrouw Ziekenhuis Aalst, Belgium
Official's Role
Principal Investigator
Facility Information:
Facility Name
OLV Hospital
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
17486918
Citation
Cammu G. How rational is muscle relaxation during cardiac surgery? Acta Anaesthesiol Belg. 2007;58(1):7-14.
Results Reference
background
PubMed Identifier
21865491
Citation
Videira RL, Vieira JE. What rules of thumb do clinicians use to decide whether to antagonize nondepolarizing neuromuscular blocking drugs? Anesth Analg. 2011 Nov;113(5):1192-6. doi: 10.1213/ANE.0b013e31822c986e. Epub 2011 Aug 24.
Results Reference
background
PubMed Identifier
8835051
Citation
Rudis MI, Guslits BG, Zarowitz BJ. Technical and interpretive problems of peripheral nerve stimulation in monitoring neuromuscular blockade in the intensive care unit. Ann Pharmacother. 1996 Feb;30(2):165-72. doi: 10.1177/106002809603000211.
Results Reference
background
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Postoperative Residual Paralysis After Cardiac Surgery
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