Electrophysiological Comparison of mAP and mADM Using EMG

Completed

• Conditions: Surgery

• Registration Number: NCT03360825
• Lead Sponsor: Mayo Clinic

Brief Summary

The primary 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

This is a blinded, single-center, prospective study in patients during surgery, requiring use of neuromuscular blockade. Neurostimulation will be used to monitor objective responses, as per current clinical routine. Data collection of Tetragraph EMG responses will be unavailable to the clinician for clinical decision-making, as per current clinical routine, but will be stored on the interfaced SD card.

Study Timeline

• Study Start: 2017-11-20
• Study First Submitted: 2017-11-22
• Study First Submitted QC: 2017-11-28
• Study First Posted: 2017-12-04
• Primary Completion: 2018-03-20
• Study Completion: 2018-03-20
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-06
• Last Update Posted: 2019-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary performance assessment of TetraGraph device	Duration of surgery	Agreement between the mAP and mADM EMG based TOF counts

Secondary Outcome Measures

Name	Time	Method
Secondary performance assessment of TetraGraph device	Duration of surgery	Comparison of EMG to the quantitative AMG monitor

Trial Locations

Locations (1)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States