Train of Four Motor Point Stimulation and Monitoring

NCT02591108 | Withdrawn

• 1 other identifier: 201501M61361
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Observation of Neuromuscular Block

Keywords

train of four; neuromuscular blockade; surgery

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Study Arms (2)

Safety and Efficacy

EXPERIMENTAL

Parallel treatment; use of standard TOF peripheral Stimulator to Novel Train of Four Device

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).

Device: Neuromuscular Block Aid; Device: Standard of Care: Microstim Plus

Interventions

Neuromuscular Block Aid DEVICE

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).

Also known as: Peripheral Nerve Stimulator - Train of Four Monitoring

Microstim; Safety and Efficacy

Standard of Care: Microstim Plus DEVICE

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).

Microstim; Safety and Efficacy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Minnesota: lead

Related Publications (2)

• 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.

  PMID: 11924844 RESULT

• Hong 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.

  PMID: 15804857 RESULT

Study Officials

• Paul A Iaizzo, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2015
• First Posted: October 29, 2015
• Study Start: January 1, 2018
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2019
• Last Updated: March 2, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share