Clinical Trial: Improving Neuromuscular Monitoring and Reducing Residual Neuromuscular Blockade Via E-learning

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: Improving Neuromuscular Monitoring and Reducing Residual Neuromuscular Blockade Via E-learning - a Multicenter Interrupted Time Series Study (INVERT Study)

Brief Summary:

To assess the impact of an e-learning course in neuromuscular monitoring on the frequency of application of objective neuromuscular monitoring for assessment of depth of neuromuscular blockade in general anaesthesia and secondarily on the incidence of residual neuromuscular blockade after anesthesia.

We will collect data prospectively from 6 Danish anaesthesia departments from the time of intervention, using data from the Anaesthesia Information Management System (AIMS). Baseline data is obtained from another study based on the same data extraction procedure (NCT02914119).


Detailed Summary:
Sponsor: Herlev Hospital

Current Primary Outcome:

  • Application of objective neuromuscular monitoring (acceleromyography) in cases receiving a depolarizing neuromuscular blocking agent (NMBA) (succinylcholine) (yes/no) [ Time Frame: in the period from induction of anaesthesia to termination of anaesthesia, usually 2 hours ]
  • Application of objective neuromuscular monitoring (acceleromyography) in cases receiving a non-depolarizing NMBA (yes/no) [ Time Frame: in the period from induction of anaesthesia to termination of anaesthesia, usually 2 hours ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Last recorded train-of-four (TOF) ratio before tracheal extubation or removal of supraglottic airway device in patients receiving a non-depolarizing NMBA [ Time Frame: in the period from induction of anaesthesia to termination of anaesthesia, usually 2 hours] ]
    we will include both an analysis where cases with a train-of-four (TOF) count between 0 and 3 (and hence no TOF ratio reported) is included as a TOF ratio of 0 and a per-protocol analysis where only cases with an actual TOF ratio is included
  • Administration of sugammadex in cases receiving a non-depolarizing NMBA (yes/no) [ Time Frame: in the period from induction of anaesthesia to discharge from the post-anaesthesia care unit, usually 5 hours ]
  • Administration of neostigmine in cases receiving a non-depolarizing NMBA (yes/no) [ Time Frame: in the period from induction of anaesthesia to discharge from the post-anaesthesia care unit, usually 5 hours ]
  • Administration of more than one reversal agent in cases receiving a non-depolarizing NMBA (yes/no) [ Time Frame: in the period from induction of anaesthesia to discharge from the post-anaesthesia care unit, usually 5 hours ]
  • Timing of NMBA reversal with sugammadex or neostigmine, respectively [ Time Frame: in the period from induction of anaesthesia to discharge from the post-anaesthesia care unit, usually 5 hours ]
    according to an ordinal scale (neostigmine: TOF count 0, 1, 2, 3, [TOF count 4 to TOF ratio 0.9], TOF ratio ≥0.9) (sugammadex: post tetanic count (PTC) 0, PTC 1 to 15, TOF 0, 1, 2, 3 [TOF count 4 to TOF ratio 0.9], TOF ratio ≥0.9)
  • Administration of an NMBA before tracheal intubation (yes/no) [ Time Frame: in the period from induction of anaesthesia to termination of anaesthesia, usually 2 hours ]
  • Application of neuromuscular monitoring before tracheal intubation in cases receiving a non-depolarizing NMBA (yes/no) [ Time Frame: in the period from induction of anaesthesia to termination of anaesthesia, usually 2 hours ]
  • Time in minutes from tracheal extubation or removal of supraglottic airway device to discharge from post-anaesthesia care unit in cases involving a non-depolarizing NMBA with and without neuromuscular monitoring, respectively [ Time Frame: in the period from induction of anaesthesia to discharge from the post-anaesthesia care unit, usually 180 minutes ]
  • Pre- and post-course test score [ Time Frame: in the 2-week intervention period where the e-learning course is completed ]


Original Secondary Outcome: Same as current

Information By: Herlev Hospital

Dates:
Date Received: October 4, 2016
Date Started: November 21, 2016
Date Completion:
Last Updated: February 21, 2017
Last Verified: February 2017