Electromyographic Assessment of the TetraGraph in Normal Volunteers

NCT ID: NCT02912039

Last Updated: 2023-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-03-31

Brief Summary

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There is an urgent need for an easy-to-use and accurate quantitative neuromuscular monitor in the clinical setting. The aim of this clinical investigation is to examine a prototype of a quantitative monitoring instrument that will meet most, if not all, of the clinical requirements.

Detailed Description

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Conditions

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Neuromuscular Blockade

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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TetraGraph

A sequence of 3 sets of Train of four (TOF) stimuli delivered (every 20 sec) at the pre-determined current amplitude (for instance, 40 mA, then 30 mA, then 50 mA, then 20 mA).

Intervention Type DEVICE

TOF Watch

A sequence of 3 sets of TOF stimuli delivered (every 20 sec) at the pre-determined current amplitude (for instance, 40 mA, then 30 mA, then 50 mA, then 20 mA).

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Age 18 years or older
2. Volunteer meets the American Society of Anesthesiology (ASA) physical status I-III criteria
3. Volunteer has provided verbal informed consent

Exclusion Criteria

1. Presence of an underlying neuromuscular disease
2. Use of medications known to interfere with neuromuscular transmission
3. Volunteer has open sores/rashes at the locations needed for electrode application
4. Volunteer does not tolerate a trial electrical stimulation comfortably.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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J. Ross Renew, M.D.

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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16-005022

Identifier Type: -

Identifier Source: org_study_id

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