AnesthesiaNCT04406740
Clinical Evaluation of a Novel Neuromuscular Blockade Monitoring System
An observational study of Anesthesia, run by University of Minnesota at 1 site in United States.
Trial summary
This study is designed to formally evaluate the performance of the QTOF, as compared with the newest commercially available NMB monitoring equipment, EMG (the TwitchView). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia
- What is being tested?
- TwitchView EMG Unit and Novel QTOF Device
- Type of treatment
- Medical device
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2018to 1 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients >18 years of age, who are scheduled to undergo any elective procedure under general anesthesia in the MHealth East Bank operating rooms in which the administration of a nondepolarizing neuromuscular blocking drug (rocuronium or cisatracurium) is anticipated.
Who may be able to join
- patients scheduled to undergo any elective procedure under general anesthesia in the MHealth East Bank operating rooms in which the administration of a nondepolarizing neuromuscular blocking drug (rocuronium or cisatracurium) is anticipated
Who cannot join
- Emergent procedures will be excluded
- Procedures performed outside of regular Monday to Friday working hours will be excluded
- Inability to provide their own consent
Trial locations and contacts
1 site in 1 country.
United States1 site
MHealth Farview University of Minnesota Medical Center
Minneapolis, Minnesota, 55455
About this study
This study is designed to formally evaluate the performance of the QTOF, as compared with the newest commercially available NMB monitoring equipment, EMG (the TwitchView).
Read the detailed description
The disposable stimulus/recording electrode array for the TwitchView will be placed on one of the patient's wrist/hand and connected to the device. Next, the stimulating electrodes and vibration sensor of the QTOF device will be placed over the contralateral ulnar nerve and thenar eminence. The devices will be placed prior to the induction of anesthesia - but no electrical stimuli will be delivered until AFTER the patient is asleep (as per routine). After induction, both devices will be started. The TwitchView automatically selects the appropriate stimulus current (takes about 10 seconds) - and when that is complete, the QTOF stimulus current will be set to the same value. The stimulus interval for both devices will be 20 seconds. Paired measurements of twitch count and TOF ratios will be gathered for the entirety of the surgical procedure, and cross checked with Epic regarding the administration of neuromuscular blocking drugs (time, dose) and reversal agents (time, dose). RAs will be present to verify the correct function of both devices. Note that information from the TwitchView monitor will be continuous available to the providers (it is a standard device available for use in our ORs). Information from the QTOF will NOT be made available to providers.
- Conditions
- Anesthesia
- Being tested
- TwitchView EMG Unit, Novel QTOF Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TwitchView EMG UnitDevice
The TwitchView device is a new generation electromyographic monitor that uses a disposable electrode array that combines stimulating and recording electrodes.
Novel QTOF DeviceDevice
The QTOF consists of an electrical stimulator that is just like the stimulator in the traditional TOF devices that are commonly used (both accelerometric and EMG-based), combined with a novel sensor that sticks to the belly of the muscle being measured (most commonly the adductor pollicis, the thumb muscle in the palm of the hand).
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Adult patients >18 years of age, who are scheduled to undergo any elective procedure under general anesthesia in the MHealth East Bank operating rooms in which the administration of a nondepolarizing neuromuscular blocking drug (rocuronium or cisatracurium) is anticipated. Receives: Device: TwitchView EMG Unit; Device: Novel QTOF Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Train-of-Four (TOF) Ratio
The train-of-four ratio (unitless measure) is calculated by comparing the magnitude of the fourth evoked response or twitch (T4) to that of the first response (T1).
Measured: 420 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start18 Jun 2018
- Primary completion1 Jun 2021
- Study completion1 Jun 2021
Why it stopped: Device malfunction
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Todd, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04406740
- Sponsor's protocol ID
- ANES-2020-28905
- Status last verified
- Feb 2023
- First submitted
- 22 May 2020
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of a Novel Neuromuscular Blockade Monitoring System
- ClinicalTrials.gov ID
- NCT04406740
- Acronym / sponsor ID
- ANES-2020-28905
- Conditions
- Anesthesia
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Device malfunction
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 18 Jun 2018 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 28 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to formally evaluate the performance of the QTOF, as compared with the newest commercially available NMB monitoring equipment, EMG (the TwitchView).
Detailed description
The disposable stimulus/recording electrode array for the TwitchView will be placed on one of the patient's wrist/hand and connected to the device. Next, the stimulating electrodes and vibration sensor of the QTOF device will be placed over the contralateral ulnar nerve and thenar eminence. The devices will be placed prior to the induction of anesthesia - but no electrical stimuli will be delivered until AFTER the patient is asleep (as per routine). After induction, both devices will be started. The TwitchView automatically selects the appropriate stimulus current (takes about 10 seconds) - and when that is complete, the QTOF stimulus current will be set to the same value. The stimulus interval for both devices will be 20 seconds. Paired measurements of twitch count and TOF ratios will be gathered for the entirety of the surgical procedure, and cross checked with Epic regarding the administration of neuromuscular blocking drugs (time, dose) and reversal agents (time, dose). RAs will be present to verify the correct function of both devices. Note that information from the TwitchView monitor will be continuous available to the providers (it is a standard device available for use in our ORs). Information from the QTOF will NOT be made available to providers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | – | Device: TwitchView EMG Unit, Device: Novel QTOF DeviceAdult patients >18 years of age, who are scheduled to undergo any elective procedure under general anesthesia in the MHealth East Bank operating rooms in which the administration of a nondepolarizing neuromuscular blocking drug (rocuronium or cisatracurium) is anticipated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients >18 years of age, who are scheduled to undergo any elective procedure under general anesthesia in the MHealth East Bank operating rooms in which the administration of a nondepolarizing neuromuscular blocking drug (rocuronium or cisatracurium) is anticipated.
Key inclusion criteria (1 listed)
- patients scheduled to undergo any elective procedure under general anesthesia in the MHealth East Bank operating rooms in which the administration of a nondepolarizing neuromuscular blocking drug (rocuronium or cisatracurium) is anticipated
Key exclusion criteria (3 listed)
- Emergent procedures will be excluded
- Procedures performed outside of regular Monday to Friday working hours will be excluded
- Inability to provide their own consent
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 |
|---|---|---|
| TwitchView EMG UnitThe TwitchView device is a new generation electromyographic monitor that uses a disposable electrode array that combines stimulating and recording electrodes. | Device | All Participants |
| Novel QTOF DeviceThe QTOF consists of an electrical stimulator that is just like the stimulator in the traditional TOF devices that are commonly used (both accelerometric and EMG-based), combined with a novel sensor that sticks to the belly of the muscle being measured (most commonly the adductor pollicis, the thumb muscle in the palm of the hand). | Device | All Participants |
Primary outcome
Train-of-Four (TOF) Ratio
Time frame: 420 minutes
The train-of-four ratio (unitless measure) is calculated by comparing the magnitude of the fourth evoked response or twitch (T4) to that of the first response (T1).
Results and safety
The study was stopped early (reason given: Device malfunction). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
- Individual participant dataSharing planned: Undecided
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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.
Michael Todd, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Feb 2023. 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 United States. 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?
The study was stopped early (reason given: Device malfunction). Results are not available in the source record.
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?
Train-of-Four (TOF) Ratio (time frame: 420 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Feb 2023.