Postoperative Residual Paralysis After Cardiac Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03291184
Recruitment Status : Completed
First Posted : September 25, 2017
Last Update Posted : April 10, 2018
Information provided by (Responsible Party):
Guy CAMMU, Onze Lieve Vrouw Hospital

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.

Condition or disease Intervention/treatment Phase
Postoperative Residual Curarization Device: peripheral neuromuscular monitor Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Patients admitted to the ICU after elective cardiac surgery and ready for weaning from the ventilator.
Masking: Double (Participant, Investigator)
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.
Primary Purpose: Diagnostic
Official Title: Is Postoperative Residual Curarisation Still an Issue at the Moment of Weaning of the ICU Patient Following Cardiac Surgery?
Actual Study Start Date : September 4, 2017
Actual Primary Completion Date : January 2, 2018
Actual Study Completion Date : March 8, 2018

Resource links provided by the National Library of Medicine

Intervention Details:
  • Device: peripheral neuromuscular monitor
    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 Measures :
  1. postoperative residual curarisation [ Time Frame: 6 hours after arrival in the ICU ]
    mean train-of-four <90% as measured by neuromuscular blockade monitoring

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • patients admitted to the ICU after elective cardiac surgery

Exclusion Criteria:

  • emergency cardiac surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03291184

OLV Hospital
Aalst, Belgium, 9300
Sponsors and Collaborators
Onze Lieve Vrouw Hospital
Principal Investigator: GUY CAMMU Onze-Lieve-Vrouw Ziekenhuis Aalst, Belgium

Responsible Party: Guy CAMMU, MD, PhD, Staff Anesthesiologist, Onze Lieve Vrouw Hospital Identifier: NCT03291184     History of Changes
Other Study ID Numbers: EN_GC_2017
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Guy CAMMU, Onze Lieve Vrouw Hospital:
neuromuscular blockade
neuromuscular monitoring

Additional relevant MeSH terms:
Delayed Emergence from Anesthesia
Postoperative Complications
Pathologic Processes