Back to resultsImproving Neuromuscular Monitoring and Reducing Residual Neuromuscular Blockade Via E-learning (INVERT)
Primary Purpose
Neuromuscular Blockade
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
E-learning course in neuromuscular monitoring
Sponsored by
About this trial
This is an interventional health services research trial for Neuromuscular Blockade focused on measuring Residual nerve blockade, Neuromuscular monitoring, Residual curarization, Neuromuscular blocking agents, E-learning, Web based learning
Eligibility Criteria
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.
Sites / Locations
- Herlev Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
E-learning course
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Last Recorded Train-of-four (TOF) Ratio Before Tracheal Extubation or Removal of Supraglottic Airway Device in Patients Receiving a Non-depolarizing NMBA
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.
Administration of Sugammadex in Cases Receiving a Non-depolarizing NMBA (Yes/no)
If the total dose of sugammadex in the anaesthesia information management system is > 0, the outcome is "yes".
Administration of Neostigmine in Cases Receiving a Non-depolarizing NMBA (Yes/no)
If the total dose of neostigmine in the anaesthesia information management system is > 0, the outcome is "yes".
Administration of More Than One Reversal Agent in Cases Receiving a Non-depolarizing NMBA (Yes/no)
If the total dose of neostigmine is bigger than (>) the first dose administered, the outcome is "yes".
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
Full Information
NCT ID
NCT02925143
First Posted
October 4, 2016
Last Updated
April 26, 2021
Sponsor
Herlev Hospital
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT02925143
Brief Title
Improving Neuromuscular Monitoring and Reducing Residual Neuromuscular Blockade Via E-learning
Acronym
INVERT
Official Title
Improving Neuromuscular Monitoring and Reducing Residual Neuromuscular Blockade Via E-learning - a Multicenter Interrupted Time Series Study (INVERT Study)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
November 21, 2016 (Actual)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
June 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Herlev Hospital
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuromuscular Blockade
Keywords
Residual nerve blockade, Neuromuscular monitoring, Residual curarization, Neuromuscular blocking agents, E-learning, Web based learning
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6525 (Actual)
8. Arms, Groups, and Interventions
Arm Title
E-learning course
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
E-learning course in neuromuscular monitoring
Intervention Description
An e-learning course designed to assess the challenges and common problems experienced by anesthetists when monitoring the neuromuscular blockade during general anesthesia.
Primary Outcome Measure Information:
Title
Application of Objective Neuromuscular Monitoring (Acceleromyography) in Cases Receiving a Depolarizing Neuromuscular Blocking Agent (NMBA) (Succinylcholine) (Yes/no)
Description
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.
Time Frame
in the period from induction of anaesthesia to termination of anaesthesia, usually 2 hours
Title
Application of Objective Neuromuscular Monitoring (Acceleromyography) in Cases Receiving a Non-depolarizing NMBA (Yes/no)
Description
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.
Time Frame
in the period from induction of anaesthesia to termination of anaesthesia, usually 2 hours
Secondary Outcome Measure Information:
Title
Last Recorded Train-of-four (TOF) Ratio Before Tracheal Extubation or Removal of Supraglottic Airway Device in Patients Receiving a Non-depolarizing NMBA
Description
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.
Time Frame
in the period from induction of anaesthesia to termination of anaesthesia, usually 2 hours]
Title
Administration of Sugammadex in Cases Receiving a Non-depolarizing NMBA (Yes/no)
Description
If the total dose of sugammadex in the anaesthesia information management system is > 0, the outcome is "yes".
Time Frame
in the period from induction of anaesthesia to discharge from the post-anaesthesia care unit, usually 5 hours
Title
Administration of Neostigmine in Cases Receiving a Non-depolarizing NMBA (Yes/no)
Description
If the total dose of neostigmine in the anaesthesia information management system is > 0, the outcome is "yes".
Time Frame
in the period from induction of anaesthesia to discharge from the post-anaesthesia care unit, usually 5 hours
Title
Administration of More Than One Reversal Agent in Cases Receiving a Non-depolarizing NMBA (Yes/no)
Description
If the total dose of neostigmine is bigger than (>) the first dose administered, the outcome is "yes".
Time Frame
in the period from induction of anaesthesia to discharge from the post-anaesthesia care unit, usually 5 hours
Title
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
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jakob L Thomsen, MD
Organizational Affiliation
Sponsor principal investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Herlev Hospital
City
Herlev
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Sharing of data not included in the permissions granted by authorities stated below
Citations:
PubMed Identifier
35122234
Citation
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.
Results Reference
derived
PubMed Identifier
28986337
Citation
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 Reference
derived
Learn more about this trial
Improving Neuromuscular Monitoring and Reducing Residual Neuromuscular Blockade Via E-learning
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