Clinical trial NCT02925143: Improving Neuromuscular Monitoring and Reducing Residual Neuromuscular Blockade Via E-learning
Official title: Improving Neuromuscular Monitoring and Reducing Residual Neuromuscular Blockade Via E-learning - a Multicenter Interrupted Time Series Study (INVERT Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuromuscular Blockade
Keywords: Residual nerve blockade
Neuromuscular monitoring
Residual curarization
Neuromuscular blocking agents
E-learning
Web based learning
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2016-10-05
Enrollment: 6525
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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).


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.

Primary outcomes:
measure: Application of Objective Neuromuscular Monitoring (Acceleromyography) in Cases Receiving a Depolarizing Neuromuscular Blocking Agent (NMBA) (Succinylcholine) (Yes/no)
timeFrame: in the period from induction of anaesthesia to termination of anaesthesia, usually 2 hours
measure: Application of Objective Neuromuscular Monitoring (Acceleromyography) in Cases Receiving a Non-depolarizing NMBA (Yes/no)
timeFrame: in the period from induction of anaesthesia to termination of anaesthesia, usually 2 hours
Secondary outcomes:
measure: Last Recorded Train-of-four (TOF) Ratio Before Tracheal Extubation or Removal of Supraglottic Airway Device in Patients Receiving a Non-depolarizing NMBA
timeFrame: in the period from induction of anaesthesia to termination of anaesthesia, usually 2 hours]
measure: Administration of Sugammadex in Cases Receiving a Non-depolarizing NMBA (Yes/no)
timeFrame: in the period from induction of anaesthesia to discharge from the post-anaesthesia care unit, usually 5 hours
measure: Administration of Neostigmine in Cases Receiving a Non-depolarizing NMBA (Yes/no)
timeFrame: in the period from induction of anaesthesia to discharge from the post-anaesthesia care unit, usually 5 hours
measure: Administration of More Than One Reversal Agent in Cases Receiving a Non-depolarizing NMBA (Yes/no)
timeFrame: in the period from induction of anaesthesia to discharge from the post-anaesthesia care unit, usually 5 hours
measure: 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
timeFrame: in the period from induction of anaesthesia to discharge from the post-anaesthesia care unit, usually 180 minutes
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev Hospital
Study officials:
affiliation: Sponsor principal investigator
name: Jakob L Thomsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.