Observation of Neuromuscular BlockNCT02591108
Train of Four Motor Point Stimulation and Monitoring
A study testing Neuromuscular Block Aid in people with Observation of Neuromuscular Block, run by University of Minnesota.
Trial summary
The assessment of neuromuscular blockage is common practice in the operating room, in which such agents are employed. Still today, the use of simple hand held stimulators and visual monitoring of these responses are the norm. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Observation of Neuromuscular Block
- What is being tested?
- Neuromuscular Block Aid
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2018to Nov 2019
- Phase
- Interventional
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Normal, healthy subjects (adults) admitted for surgical procedures.
Who cannot join
- Under 18 years of age or over 80 years of age, anesthetic paradigm does not include NMBAs.
About this study
Official title: Quantitative Assessment of Train of Four Device for Patients Receiving Neuromuscular Blockade
The assessment of neuromuscular blockage is common practice in the operating room, in which such agents are employed. Still today, the use of simple hand held stimulators and visual monitoring of these responses are the norm. The investigators want to study the potential for employing a non-invasive quantitative device with built in sensors that will hopefully accurately determine the degree of neuromuscular blockade. This system utilizes commonly employed train of four (TOF) electrical stimulation pulses, an incorporated force sensor and an automated detection system. This system will not only utilized pre-blockade, but also throughout an entire surgical procedure and during reversal therapy. For comparisons, the investigators will use both the prototype device and a standard hand held TOF for the assessment of neuromuscular blockage. In other words, the planned protocol will involve testing the effectiveness and accuracy of the device concurrently with peripheral nerve stimulation, during a procedure as is done for the current standard of care. All protocols will be carried out under the direct guidance and supervision of anesthesiologists and/or nurse anesthetists.
Read the detailed description
Project Summary:
In this study the investigators propose to evaluate a train of four (TOF) stimulator that assess the neuromuscular junction of a patient under anesthesia. The goal of this project is to evaluate a novel device in comparison to the standard of care with a hand held stimulator.
Background and Significance:
The assessment of neuromuscular blockage is common practice in the operating room, in which such agents are employed. Still today, the use of simple hand held stimulators and visual monitoring of these responses are the norm. The investigators now want to study the potential for employing a non-invasive quantitative device with built in sensors that will hopefully accurately determine the degree of neuromuscular blockade. This system utilizes commonly employed train of four (TOF) electrical stimulation pulses, an incorporated force sensor and an automated detection system. This system will not only utilized pre-blockade, but also throughout an entire surgical procedure and during reversal therapy. For comparisons, we will use both the prototype device and a standard hand held TOF for the assessment of neuromuscular blockage.
In other words, the planned protocol will involve testing the effectiveness and accuracy of the device concurrently with peripheral nerve stimulation, during a procedure as is done for the current standard of care. All protocols will be carried out under the direct guidance and supervision of anesthesiologists and/or nurse anesthetists.
The procedure involves applying the device to a suitable anatomic location for train of four (TOF) stimulation/monitoring and then applying a small electrical pulse to stimulate the patient's motor point. The location for this stimulation has historically been on the patients forearm over the ulnar nerve area or on the patients face in the distribution of the facial nerve. The stimulation applied to these areas is equivalent to that applied in the current accepted standard of care. All responses measured by the device will be recorded electronically and compared to anesthesiologist's/nurse anesthetist's interpretation of the number of muscle twitches induced by peripheral motor point stimulation. These comparisons will be analyzed for correlation between number of muscle twitches and degree of force generation sensed by the device, with the aim of more accurately determining the degree of the patients neuromuscular blockade.
This device application and monitoring will be carried out on anesthetized surgical patients at different time points in the procedure, under the same conditions as the currently utilized peripheral nerve stimulators to judge neuromuscular transmission and anesthesia effectiveness. We will also use the system on other anatomical locations that may be easier to gain assess to under certain surgical procedures: e.g., on the bicep, quadriceps, or tibialis anterior muscles. Such locations have been described by anesthesiologists as viable options.
Pre and post-surgical care will be unchanged and follow current standard of care. The only change will be that alongside current peripheral nerve stimulation, our non-invasive TOF device will also be utilized for assessing the relative degree of neuromuscular blockage.
Currently, there is no clinically available device that is automated and records the TOF conducted the anesthesiologist and their staff. Developing a method for completed this assessment is expected to save the anesthesiologist's time and prevent human error and increase consistency.
This device and approach is similar to the muscle force system which we have employed to study patients with neuromuscular disorders at the University of Minnesota for over 20 years.
Specific Aims/Study Objectives:
The investigators hypothesize that the use of an advance TOF device with automated data storage and a unique user interface will demonstrate enhanced efficacy for monitoring neuromuscular blockade in patients. The investigators will continue to recruit subjects for this study until we have completed the study.
Research Design and Methods:
The study population will include female and male participants ranging from 18-80 years of age. The investigators are requesting a total of 400 participants in the study. After the investigators have collected data from these individuals they will analyze the data to determine the efficacy of the testing method. If the initial population size is extremely variable or does not allow the investigators to conduct a proper analysis, they will request additional subjects to make a conclusion on this device.
Subject will be identified by the anesthesiologist prior to surgery, consent will be obtained prior to surgical procedures. The information that will be collected from their medical records will include their age, height, weight, history of muscular disease i.e. myotonias, malignant hyperthermia, previous adverse reactions to anesthesia, complete anesthetic records from procedure. Data will be securely stored and locked in Mayo B172.
Data and Safety Monitoring Plan:
It is not anticipated that the use of this device will produce any side effects or emotional upset. The stopping rules of the study include any unexpected complications with the use of the TOF stimulator in the OR. The patient will be unconscious or sedated during monitoring.
Statistical Considerations:
Historically, FDA clinical trials have utilized anywhere from 100-400 patients for determining the relative safety and efficacy of a medical device or technology. The obtained data will be analyzed to determine such factors and could be utilized for FDA approval of a monitoring system for clinical use.
Direct comparison of the devices qualitative evaluation of scoring from the administering anesthesiologist will be used for the final analysis.
Data and Record Keeping:
The data will be recorded by Dr. Michael Loushin, Dr. Paul Iaizzo, Dr. Jake Hutch, Tinen Iles, the data will be stored securely in Mayo B172 or with the anesthesiologist. The data will be stored from the automated TOF and the manual TOF performed in Mayo B172 or with the anesthesiologist.
References:
- Conditions
- Observation of Neuromuscular Block
- Being tested
- Neuromuscular Block Aid, Standard of Care: Microstim Plus
- Keywords
- train of four, neuromuscular blockade, surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular Block AidDevice
Also called Peripheral Nerve Stimulator - Train of Four Monitoring
Neuromuscular Block Aid, is a quantitative mechansim for collecting the the train-of-four and can be kept in an electronic medical record, also known as a train-of-four monitor, is used to assess neuromuscular transmission when neuromuscular blocking agents (NMBAs) are given to block musculoskeletal activity. By assessing the depth of neuromuscular blockade, peripheral nerve stimulation/monitoring can ensure proper medication dosing and thus decrease the incidence of side effects. Peripheral nerve stimulation is most commonly used for ongoing monitoring in the intensive care unit (ICU).
Standard of Care: Microstim PlusDevice
A peripheral nerve stimulator, also known as a train-of-four monitor, is used to assess neuromuscular transmission when neuromuscular blocking agents (NMBAs) are given to block musculoskeletal activity. By assessing the depth of neuromuscular blockade, peripheral nerve stimulation/monitoring can ensure proper medication dosing and thus decrease the incidence of side effects. Peripheral nerve stimulation is most commonly used for ongoing monitoring in the intensive care unit (ICU).
| Study group | Role | What they receive |
|---|---|---|
| Safety and Efficacy | Experimental | Parallel treatment; use of standard TOF peripheral Stimulator to Novel Train of Four Device Receives: Device: Neuromuscular Block Aid; Device: Standard of Care: Microstim Plus |
| Microstim | Active comparator | A peripheral nerve stimulator, also known as a train-of-four monitor, is used to assess neuromuscular transmission when neuromuscular blocking agents (NMBAs) are given to block musculoskeletal activity. By assessing the depth of neuromuscular blockade, peripheral nerve stimulation/monitoring can ensure proper medication dosing and thus decrease the incidence of side effects. Peripheral nerve stimulation is most commonly used for ongoing monitoring in the intensive care unit (ICU). Receives: Device: Neuromuscular Block Aid; Device: Standard of Care: Microstim Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative Amplitude of Force in the Neuromuscular Block Aid compared to the Qualitative Standard of Care Observations
FDA clinical trials have utilized ~100-400 patients to determine the relative safety and efficacy of a medical device. Direct comparison of the devices qualitative evaluation of scoring from the administering anesthesiologist will be used for the final analysis.
A peripheral nerve stimulator, used to elicit a train-of-four (TOF) response, allows the assessment of neuromuscular blockade. Subjectively they determine the relative depth by visualizing TOF responses.If the first and last stimulus in a TOF elicit no force, this indicates blockade, or if the TOF has equal amplitudes, this indicates no blockade or reversal. Return of muscle force is required before the patient can be extubated.
Current peripheral nerve stimulators rely on visual subjective analysis of relative contractions, whereas our investigational device will provide a quantitative assessment of the amplitude of the muscle contraction in grams and percent amplitudes of measured forces relative to the first stimulus.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study start1 Jan 2018 (estimated)
- Primary completionNov 2018 (estimated)
- Study completionNov 2019 (estimated)
Why it stopped: No Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Observation of Neuromuscular BlockStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul A Iaizzo, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02591108
- Sponsor's protocol ID
- 201501M61361
- Status last verified
- Feb 2018
- First submitted
- 18 Mar 2015
- Last updated
- 2 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hong JB, Iaizzo PA. Force assessment of the stimulated arm flexors: quantification of contractile properties. J Med Eng Technol. 2002 Jan-Feb;26(1):28-35. doi: 10.1080/03091900110099558.
PubMed 11924844Hong J, Falkenberg JH, Iaizzo PA. Stimulated muscle force assessment of the sternocleidomastoid muscle in humans. J Med Eng Technol. 2005 Mar-Apr;29(2):82-9. doi: 10.1080/03091900412331271158.
PubMed 15804857
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Assessment of Train of Four Device for Patients Receiving Neuromuscular Blockade
- ClinicalTrials.gov ID
- NCT02591108
- Acronym / sponsor ID
- 201501M61361
- Conditions
- Observation of Neuromuscular Block
- Keywords
- train of four, neuromuscular blockade, surgery
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No Funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Jan 2018 (estimated)
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 29 Oct 2015 (estimated)
- 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.
The assessment of neuromuscular blockage is common practice in the operating room, in which such agents are employed. Still today, the use of simple hand held stimulators and visual monitoring of these responses are the norm. The investigators want to study the potential for employing a non-invasive quantitative device with built in sensors that will hopefully accurately determine the degree of neuromuscular blockade. This system utilizes commonly employed train of four (TOF) electrical stimulation pulses, an incorporated force sensor and an automated detection system. This system will not only utilized pre-blockade, but also throughout an entire surgical procedure and during reversal therapy. For comparisons, the investigators will use both the prototype device and a standard hand held TOF for the assessment of neuromuscular blockage. In other words, the planned protocol will involve testing the effectiveness and accuracy of the device concurrently with peripheral nerve stimulation, during a procedure as is done for the current standard of care. All protocols will be carried out under the direct guidance and supervision of anesthesiologists and/or nurse anesthetists.
Detailed description
Project Summary:
In this study the investigators propose to evaluate a train of four (TOF) stimulator that assess the neuromuscular junction of a patient under anesthesia. The goal of this project is to evaluate a novel device in comparison to the standard of care with a hand held stimulator.
Background and Significance:
The assessment of neuromuscular blockage is common practice in the operating room, in which such agents are employed. Still today, the use of simple hand held stimulators and visual monitoring of these responses are the norm. The investigators now want to study the potential for employing a non-invasive quantitative device with built in sensors that will hopefully accurately determine the degree of neuromuscular blockade. This system utilizes commonly employed train of four (TOF) electrical stimulation pulses, an incorporated force sensor and an automated detection system. This system will not only utilized pre-blockade, but also throughout an entire surgical procedure and during reversal therapy. For comparisons, we will use both the prototype device and a standard hand held TOF for the assessment of neuromuscular blockage.
In other words, the planned protocol will involve testing the effectiveness and accuracy of the device concurrently with peripheral nerve stimulation, during a procedure as is done for the current standard of care. All protocols will be carried out under the direct guidance and supervision of anesthesiologists and/or nurse anesthetists.
The procedure involves applying the device to a suitable anatomic location for train of four (TOF) stimulation/monitoring and then applying a small electrical pulse to stimulate the patient's motor point. The location for this stimulation has historically been on the patients forearm over the ulnar nerve area or on the patients face in the distribution of the facial nerve. The stimulation applied to these areas is equivalent to that applied in the current accepted standard of care. All responses measured by the device will be recorded electronically and compared to anesthesiologist's/nurse anesthetist's interpretation of the number of muscle twitches induced by peripheral motor point stimulation. These comparisons will be analyzed for correlation between number of muscle twitches and degree of force generation sensed by the device, with the aim of more accurately determining the degree of the patients neuromuscular blockade.
This device application and monitoring will be carried out on anesthetized surgical patients at different time points in the procedure, under the same conditions as the currently utilized peripheral nerve stimulators to judge neuromuscular transmission and anesthesia effectiveness. We will also use the system on other anatomical locations that may be easier to gain assess to under certain surgical procedures: e.g., on the bicep, quadriceps, or tibialis anterior muscles. Such locations have been described by anesthesiologists as viable options.
Pre and post-surgical care will be unchanged and follow current standard of care. The only change will be that alongside current peripheral nerve stimulation, our non-invasive TOF device will also be utilized for assessing the relative degree of neuromuscular blockage.
Currently, there is no clinically available device that is automated and records the TOF conducted the anesthesiologist and their staff. Developing a method for completed this assessment is expected to save the anesthesiologist's time and prevent human error and increase consistency.
This device and approach is similar to the muscle force system which we have employed to study patients with neuromuscular disorders at the University of Minnesota for over 20 years.
Specific Aims/Study Objectives:
The investigators hypothesize that the use of an advance TOF device with automated data storage and a unique user interface will demonstrate enhanced efficacy for monitoring neuromuscular blockade in patients. The investigators will continue to recruit subjects for this study until we have completed the study.
Research Design and Methods:
The study population will include female and male participants ranging from 18-80 years of age. The investigators are requesting a total of 400 participants in the study. After the investigators have collected data from these individuals they will analyze the data to determine the efficacy of the testing method. If the initial population size is extremely variable or does not allow the investigators to conduct a proper analysis, they will request additional subjects to make a conclusion on this device.
Subject will be identified by the anesthesiologist prior to surgery, consent will be obtained prior to surgical procedures. The information that will be collected from their medical records will include their age, height, weight, history of muscular disease i.e. myotonias, malignant hyperthermia, previous adverse reactions to anesthesia, complete anesthetic records from procedure. Data will be securely stored and locked in Mayo B172.
Data and Safety Monitoring Plan:
It is not anticipated that the use of this device will produce any side effects or emotional upset. The stopping rules of the study include any unexpected complications with the use of the TOF stimulator in the OR. The patient will be unconscious or sedated during monitoring.
Statistical Considerations:
Historically, FDA clinical trials have utilized anywhere from 100-400 patients for determining the relative safety and efficacy of a medical device or technology. The obtained data will be analyzed to determine such factors and could be utilized for FDA approval of a monitoring system for clinical use.
Direct comparison of the devices qualitative evaluation of scoring from the administering anesthesiologist will be used for the final analysis.
Data and Record Keeping:
The data will be recorded by Dr. Michael Loushin, Dr. Paul Iaizzo, Dr. Jake Hutch, Tinen Iles, the data will be stored securely in Mayo B172 or with the anesthesiologist. The data will be stored from the automated TOF and the manual TOF performed in Mayo B172 or with the anesthesiologist.
References:
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Safety and Efficacy | Experimental | Device: Neuromuscular Block Aid, Device: Standard of Care: Microstim PlusParallel treatment; use of standard TOF peripheral Stimulator to Novel Train of Four Device |
| Microstim | Active comparator | Device: Neuromuscular Block Aid, Device: Standard of Care: Microstim PlusA peripheral nerve stimulator, also known as a train-of-four monitor, is used to assess neuromuscular transmission when neuromuscular blocking agents (NMBAs) are given to block musculoskeletal activity. By assessing the depth of neuromuscular blockade, peripheral nerve stimulation/monitoring can ensure proper medication dosing and thus decrease the incidence of side effects. Peripheral nerve stimulation is most commonly used for ongoing monitoring in the intensive care unit (ICU). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Normal, healthy subjects (adults) admitted for surgical procedures.
Key exclusion criteria (1 listed)
- Under 18 years of age or over 80 years of age, anesthetic paradigm does not include NMBAs.
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 |
|---|---|---|
| Neuromuscular Block AidAlso: Peripheral Nerve Stimulator - Train of Four MonitoringNeuromuscular Block Aid, is a quantitative mechansim for collecting the the train-of-four and can be kept in an electronic medical record, also known as a train-of-four monitor, is used to assess neuromuscular transmission when neuromuscular blocking agents (NMBAs) are given to block musculoskeletal activity. By assessing the depth of neuromuscular blockade, peripheral nerve stimulation/monitoring can ensure proper medication dosing and thus decrease the incidence of side effects. Peripheral nerve stimulation is most commonly used for ongoing monitoring in the intensive care unit (ICU). | Device | Microstim, Safety and Efficacy |
| Standard of Care: Microstim PlusA peripheral nerve stimulator, also known as a train-of-four monitor, is used to assess neuromuscular transmission when neuromuscular blocking agents (NMBAs) are given to block musculoskeletal activity. By assessing the depth of neuromuscular blockade, peripheral nerve stimulation/monitoring can ensure proper medication dosing and thus decrease the incidence of side effects. Peripheral nerve stimulation is most commonly used for ongoing monitoring in the intensive care unit (ICU). | Device | Microstim, Safety and Efficacy |
Primary outcome
Quantitative Amplitude of Force in the Neuromuscular Block Aid compared to the Qualitative Standard of Care Observations
Time frame: 2 years
FDA clinical trials have utilized ~100-400 patients to determine the relative safety and efficacy of a medical device. Direct comparison of the devices qualitative evaluation of scoring from the administering anesthesiologist will be used for the final analysis. A peripheral nerve stimulator, used to elicit a train-of-four (TOF) response, allows the assessment of neuromuscular blockade. Subjectively they determine the relative depth by visualizing TOF responses.If the first and last stimulus in a TOF elicit no force, this indicates blockade, or if the TOF has equal amplitudes, this indicates no blockade or reversal. Return of muscle force is required before the patient can be extubated. Current peripheral nerve stimulators rely on visual subjective analysis of relative contractions, whereas our investigational device will provide a quantitative assessment of the amplitude of the muscle contraction in grams and percent amplitudes of measured forces relative to the first stimulus.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2018.
- Results publication: PubMed 11924844Hong JB, Iaizzo PA. Force assessment of the stimulated arm flexors: quantification of contractile properties. J Med Eng Technol. 2002 Jan-Feb;26(1):28-35. doi: 10.1080/03091900110099558.
- Results publication: PubMed 15804857Hong J, Falkenberg JH, Iaizzo PA. Stimulated muscle force assessment of the sternocleidomastoid muscle in humans. J Med Eng Technol. 2005 Mar-Apr;29(2):82-9. doi: 10.1080/03091900412331271158.
- Individual participant dataSharing planned: No
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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.
Paul A Iaizzo, PhD principal investigator
University of Minnesota
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular Block Aid in people with Observation of Neuromuscular Block, run by University of Minnesota.
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 1 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: withdrawn, as of the sponsor's last update on 2 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Quantitative Amplitude of Force in the Neuromuscular Block Aid compared to the Qualitative Standard of Care Observations (time frame: 2 years). 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 NCT02591108, 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 2 Mar 2018.