NCT02925143

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,525

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 5, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

November 21, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

May 18, 2021

Completed
Last Updated

May 18, 2021

Status Verified

April 1, 2021

Enrollment Period

7 months

First QC Date

October 4, 2016

Results QC Date

March 24, 2021

Last Update Submit

April 26, 2021

Conditions

Keywords

Residual nerve blockadeNeuromuscular monitoringResidual curarizationNeuromuscular blocking agentsE-learningWeb based learning

Outcome Measures

Primary Outcomes (2)

  • Application of Objective Neuromuscular Monitoring (Acceleromyography) in Cases Receiving a Depolarizing Neuromuscular Blocking Agent (NMBA) (Succinylcholine) (Yes/no)

    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)

    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 Outcomes (5)

  • Last Recorded Train-of-four (TOF) Ratio Before Tracheal Extubation or Removal of Supraglottic Airway Device in Patients Receiving a Non-depolarizing NMBA

    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)

    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)

    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)

    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

    in the period from induction of anaesthesia to discharge from the post-anaesthesia care unit, usually 180 minutes

Study Arms (1)

E-learning course

EXPERIMENTAL
Other: E-learning course in neuromuscular monitoring

Interventions

An e-learning course designed to assess the challenges and common problems experienced by anesthetists when monitoring the neuromuscular blockade during general anesthesia.

E-learning course

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herlev Hospital

Herlev, Denmark

Location

Related Publications (2)

  • Thomsen JLD, Mathiesen O, Hagi-Pedersen D, Skovgaard LT, Ostergaard D, Gatke MR; INVERT collaborator group. Improving neuromuscular monitoring and reducing residual neuromuscular blockade via e-learning: A multicentre interrupted time-series study (INVERT study). Acta Anaesthesiol Scand. 2022 May;66(5):580-588. doi: 10.1111/aas.14038. Epub 2022 Feb 13.

  • Thomsen JLD, Mathiesen O, Hagi-Pedersen D, Skovgaard LT, Ostergaard D, Engbaek J, Gatke MR. Improving Neuromuscular Monitoring and Reducing Residual Neuromuscular Blockade With E-Learning: Protocol for the Multicenter Interrupted Time Series INVERT Study. JMIR Res Protoc. 2017 Oct 6;6(10):e192. doi: 10.2196/resprot.7527.

Results Point of Contact

Title
Dr. Jakob Thomsen
Organization
Herlev Hospital

Study Officials

  • Jakob L Thomsen, MD

    Sponsor principal investigator

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 4, 2016

First Posted

October 5, 2016

Study Start

November 21, 2016

Primary Completion

June 30, 2017

Study Completion

June 30, 2017

Last Updated

May 18, 2021

Results First Posted

May 18, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

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

Locations