Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E-learning course | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E-learning course in neuromuscular monitoring | Other | An e-learning course designed to assess the challenges and common problems experienced by anesthetists when monitoring the neuromuscular blockade during general anesthesia. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 | 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. |
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jakob L Thomsen, MD | Sponsor principal investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herlev Hospital | Herlev | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35122234 | Derived | 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. | |
| 28986337 |
Not provided
Not provided
Sharing of data not included in the permissions granted by authorities stated below
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | E-learning Course | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | E-learning Course | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Only patients who received a Depolarizing Neuromuscular Blocking Agent (NMBA) (Succinylcholine) are analyzed in this outcome. | Posted | Count of Participants | Participants | in the period from induction of anaesthesia to termination of anaesthesia, usually 2 hours |
|
4 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | E-learning Course | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jakob Thomsen | Herlev Hospital | 004538683868 | dr.j@demants.dk |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 22, 2021 | Apr 26, 2021 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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) | 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) | 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) | 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 | in the period from induction of anaesthesia to discharge from the post-anaesthesia care unit, usually 180 minutes |
| 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. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 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. | Only patients receiving a non-depolarizing neuromuscular blocking agent are analyzed in this outcome | Posted | Count of Participants | Participants | 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. | Only patients receiving a non-depolarizing neuromuscular blocking agent, monitored with acceleromyography and with a valid TOF ratio in the last three measurements are included in this outcome. | Posted | Mean | Standard Deviation | ratio | 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". | Only patients receiving a non-depolarizing neuromuscular blocking agent are analyzed in this outcome. | Posted | Count of Participants | Participants | 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". | Only patients receiving a non-depolarizing neuromuscular blocking agent are analyzed in this outcome. | Posted | Count of Participants | Participants | 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". | Only patients receiving a non-depolarizing neuromuscular blocking agent are analyzed in this outcome. | Posted | Count of Participants | Participants | 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 | Only patients receiving a non-depolarizing neuromuscular blocking agent with data on length-of-stay in the post-anaesthesia care unit are analyzed in this outcome. | Posted | Median | Full Range | minutes | in the period from induction of anaesthesia to discharge from the post-anaesthesia care unit, usually 180 minutes |
|
|
|
| 0 |
| 6,525 |
| 0 |
| 6,525 |
| 0 |
| 6,525 |
Not provided
Not provided