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Train of Four Motor Point Stimulation and Monitoring

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ClinicalTrials.gov Identifier: NCT02591108
Recruitment Status : Withdrawn (No Funding)
First Posted : October 29, 2015
Last Update Posted : March 2, 2018
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Observation of Neuromuscular Block Device: Neuromuscular Block Aid Device: Standard of Care: Microstim Plus Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Quantitative Assessment of Train of Four Device for Patients Receiving Neuromuscular Blockade
Estimated Study Start Date : January 1, 2018
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2019

Arm Intervention/treatment
Experimental: Safety and Efficacy
Parallel treatment; use of standard TOF peripheral Stimulator to Novel Train of Four Device
Device: Neuromuscular Block Aid
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).
Other Name: Peripheral Nerve Stimulator - Train of Four Monitoring

Device: Standard of Care: Microstim Plus
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).

Active Comparator: Microstim
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).
Device: Neuromuscular Block Aid
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).
Other Name: Peripheral Nerve Stimulator - Train of Four Monitoring

Device: Standard of Care: Microstim Plus
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).




Primary Outcome Measures :
  1. 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.




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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Normal, healthy subjects (adults) admitted for surgical procedures.

Exclusion Criteria:

  • Under 18 years of age or over 80 years of age, anesthetic paradigm does not include NMBAs.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02591108


Sponsors and Collaborators
University of Minnesota
Investigators
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Principal Investigator: Paul A Iaizzo, PhD University of Minnesota
Publications of Results:
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT02591108    
Other Study ID Numbers: 201501M61361
First Posted: October 29, 2015    Key Record Dates
Last Update Posted: March 2, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of Minnesota:
train of four
neuromuscular blockade
surgery