Improving Neuromuscular Monitoring and Reducing Residual Neuromuscular Blockade Via E-learning

Neuromuscular Blockade Clinical Trial

— INVERT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02925143
• Other study ID #: JLT-NM5
• Status: Completed
• Phase: N/A
• Start date: November 21, 2016
• Est. completion date: June 30, 2017

Study information

• Verified date: April 2021
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6525
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Delayed Emergence from Anesthesia
• Neuromuscular Blockade

Intervention

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.

Locations

Country	Name	City	State
Denmark	Herlev Hospital	Herlev

Sponsors (2)

Lead Sponsor	Collaborator
Herlev Hospital	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	in the period from induction of anaesthesia to termination of anaesthesia, usually 2 hours]
Secondary	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".	in the period from induction of anaesthesia to discharge from the post-anaesthesia care unit, usually 5 hours
Secondary	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".	in the period from induction of anaesthesia to discharge from the post-anaesthesia care unit, usually 5 hours
Secondary	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".	in the period from induction of anaesthesia to discharge from the post-anaesthesia care unit, usually 5 hours
Secondary	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