Neuromuscular BlockadeINVERTNCT02925143
Improving Neuromuscular Monitoring and Reducing Residual Neuromuscular Blockade Via E-learning
A study testing E-learning course in neuromuscular monitoring in people with Neuromuscular Blockade, run by Herlev Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neuromuscular Blockade
- What is being tested?
- E-learning course in neuromuscular monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,525 participants
- Where
- 1 siteDenmark
- Study dates
- 21 Nov 2016to 30 Jun 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Neuromuscular Monitoring and Reducing Residual Neuromuscular Blockade Via E-learning - a Multicenter Interrupted Time Series Study (INVERT Study)
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).
- Conditions
- Neuromuscular Blockade
- Being tested
- E-learning course in neuromuscular monitoring
- Keywords
- Residual nerve blockade, Neuromuscular monitoring, Residual curarization, Neuromuscular blocking agents, E-learning, Web based learning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-learning course in neuromuscular monitoringOther
An e-learning course designed to assess the challenges and common problems experienced by anesthetists when monitoring the neuromuscular blockade during general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| E-learning course | Experimental | Not described Receives: Other: E-learning course in neuromuscular monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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
Measured: in the period from induction of anaesthesia to discharge from the post-anaesthesia care unit, usually 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study start21 Nov 2016
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neuromuscular BlockadeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6,525 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Jakob Louis Thomsen, Herlev Hospital
- Investigators
- Jakob L Thomsen, MD, Principal investigator, Sponsor principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02925143
- Sponsor's protocol ID
- JLT-NM5
- Acronym
- INVERT
- Status last verified
- Apr 2021
- First submitted
- 4 Oct 2016
- Last updated
- 18 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: Sharing of data not included in the permissions granted by authorities stated below
Publications
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.
PubMed 35122234Thomsen 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.
PubMed 28986337
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Neuromuscular Monitoring and Reducing Residual Neuromuscular Blockade Via E-learning - a Multicenter Interrupted Time Series Study (INVERT Study)
- ClinicalTrials.gov ID
- NCT02925143
- Acronym / sponsor ID
- INVERT / JLT-NM5
- Conditions
- Neuromuscular Blockade
- Keywords
- Residual nerve blockade, Neuromuscular monitoring, Residual curarization, Neuromuscular blocking agents, E-learning, Web based learning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,525 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 21 Nov 2016 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 5 Oct 2016 (estimated)
- Results
- Posted 18 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| E-learning course | Experimental | Other: E-learning course in neuromuscular monitoring |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E-learning course in neuromuscular monitoringAn e-learning course designed to assess the challenges and common problems experienced by anesthetists when monitoring the neuromuscular blockade during general anesthesia. | Other | E-learning course |
Primary outcome
Application of Objective Neuromuscular Monitoring (Acceleromyography) in Cases Receiving a Depolarizing Neuromuscular Blocking Agent (NMBA) (Succinylcholine) (Yes/no)
Time frame: in the period from induction of anaesthesia to termination of anaesthesia, usually 2 hours
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)
Time frame: in the period from induction of anaesthesia to termination of anaesthesia, usually 2 hours
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.
5 secondary outcomes
Last Recorded Train-of-four (TOF) Ratio Before Tracheal Extubation or Removal of Supraglottic Airway Device in Patients Receiving a Non-depolarizing NMBA
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: in the period from induction of anaesthesia to discharge from the post-anaesthesia care unit, usually 180 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35122234Thomsen 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.
- Derived from this study: PubMed 28986337Thomsen 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.
- Individual participant dataSharing planned: No. Sharing of data not included in the permissions granted by authorities stated below
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jakob L Thomsen, MD principal investigator
Sponsor principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E-learning course in neuromuscular monitoring in people with Neuromuscular Blockade, run by Herlev Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Application of Objective Neuromuscular Monitoring (Acceleromyography) in Cases Receiving a Depolarizing Neuromuscular Blocking Agent (NMBA) (Succinylcholine) (Yes/no) (time frame: in the period from induction of anaesthesia to termination of anaesthesia, usually 2 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02925143, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2021.