Improving Neuromuscular Monitoring and Reducing Residual Neuromuscular Blockade Via E-learning (INVERT)

April 26, 2021 updated by: Jakob Louis Thomsen, Herlev Hospital

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6525

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Herlev, Denmark
        • Herlev Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Departments We will include the 6 largest anaesthesia departments in the Zealand Region of Denmark.

Anaesthetists We will include the following anaesthesia personnel as anaesthetists: nurse anaesthetists in training, nurse anaesthetists, first year residents in anaesthesiology, residents in the last 4 years of training in anaesthesiology, and specialist consultants in anaesthesia.

Patients We will include and collect data from all patients undergoing general anaesthesia with neuromuscular blockade in each data collection period. Patients, who are eligible more than once, i.e. undergoing general anaesthesia on more than one occasion, will be included in the analyses with a case for every general anaesthetic received.

Exclusion criteria We will exclude personnel without clinical functions, i.e. administrative personnel.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: E-learning course
Other: E-learning course in neuromuscular monitoring
An e-learning course designed to assess the challenges and common problems experienced by anesthetists when monitoring the neuromuscular blockade during general anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Number of Participants Who Received a Depolarizing Neuromuscular Blocking Agent (NMBA) (Succinylcholine) and was Monitored with Objective Neuromuscular Monitoring (Acceleromyography). Data on neuromuscular monitoring is automatically registered in the electronic patient chart when the equipment for acceleromyography is activated.
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
Number of Participants Who Received a Non-depolarizing Neuromuscular Blocking Agent (NMBA) and was Monitored with Objective Neuromuscular Monitoring (Acceleromyography). Data on neuromuscular monitoring is automatically registered in the electronic patient chart when the equipment for acceleromyography is activated.
in the period from induction of anaesthesia to termination of anaesthesia, usually 2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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]
The Train-of-four (TOF) ratio is the ratio of the fourth to the first muscle response after 4 stimuli at the ulnar nerve at the wrist at 2 Hz. The response is measured using acceleromyography. If the last measurement is performed before return of any muscle function, the ration can not be given.
in the period from induction of anaesthesia to termination of anaesthesia, usually 2 hours]
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
If the total dose of sugammadex in the anaesthesia information management system is > 0, the outcome is "yes".
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
If the total dose of neostigmine in the anaesthesia information management system is > 0, the outcome is "yes".
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
If the total dose of neostigmine is bigger than (>) the first dose administered, the outcome is "yes".
in the period from induction of anaesthesia to discharge from the post-anaesthesia care unit, usually 5 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
Time Frame: in the period from induction of anaesthesia to discharge from the post-anaesthesia care unit, usually 180 minutes
in the period from induction of anaesthesia to discharge from the post-anaesthesia care unit, usually 180 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Herlev Hospital

Collaborators

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 21, 2016

Primary Completion (ACTUAL)

June 30, 2017

Study Completion (ACTUAL)

June 30, 2017

Study Registration Dates

First Submitted

October 4, 2016

First Submitted That Met QC Criteria

October 4, 2016

First Posted (ESTIMATE)

October 5, 2016

Study Record Updates

Last Update Posted (ACTUAL)

May 18, 2021

Last Update Submitted That Met QC Criteria

April 26, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JLT-NM5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Sharing of data not included in the permissions granted by authorities stated below

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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