Evaluation of the New Acceleromyograph TOF 3D

Evaluation of the New Three-dimensional Acceleromyograph TOF 3D Compared With the Established TOF Watch SX.

The TOF 3D is a new acceleromyograph designed to assess the degree of a neuromuscular block during anesthesia. The study compares the new three-dimensional technique with the established TOF Watch SX.

Study Overview

• Status: Recruiting
• Conditions: Neuromuscular Block; Assessment of a New Acceleromyograph
• Intervention / Treatment: Diagnostic test: acceleromyography

Detailed Description

The TOF 3D is a new acceleromyograph designed to assess the degree of a neuromuscular block during anesthesia. The study compares the new three-dimensional technique with the established TOF Watch SX. The time course of a neuromuscular block (onset, maximal block, time to recovery) is assessed simultaneously with both devices in 50 patients undergoing elective gynecologic surgery requiring neuromuscular block. The validity and reliability of the new technique is evaluated with a Bland-Altman- analysis.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stefan Soltesz, Prof.; Phone Number: 00492133664500; Email: stefan.soltesz@kkh-ne.de
• Study Contact Backup: Name: Günter K Noe, MD; Phone Number: 00492133664600; Email: karl-guenter.noe@kkh-ne.de

Study Locations

• Germany
  • Dormagen, Germany, D-41540
    • Recruiting
    • KKH Dormagen
    • Contact: Soltesz, MD; Phone Number: 0049 2133 66 4500; Email: stefan.soltesz@kkh-ne.de
    • Principal Investigator: Stefan Soltesz, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Patients undergoing elective gynecologic surgery requiring general anesthesia and neuromuscular block

Exclusion Criteria:

• anticipated difficult airway
• Risk of pulmonary aspiration
• acute infection
• pregnancy
• renal or hepatic insufficiency
• neuromuscular disease
• chronic intake of drugs influencing neuromuscular block

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: adductor pollicis AP; Measurement site: M.adductor pollicis of both arms.	Diagnostic test: acceleromyography; Simultaneous measurement of the time course of a neuromuscular block with 2 acceleromyographs
Experimental: Corrugator supercilii CS; Measurement site: M. corrugator supercilii at both sides	Diagnostic test: acceleromyography; Simultaneous measurement of the time course of a neuromuscular block with 2 acceleromyographs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TOF-R 90%	Difference of the 90% train-of-four (TOF) recovery time between both devices	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
repeatability (precision)	Variance of 10 consecutive measurements around a linear regression line for each device	12 months
bias and limits of agreement (Bland-Altman analysis)	Difference between both devices against the average of both measurements (bias +- 2SD)	12 months

Collaborators and Investigators

• Sponsor: Kreiskrankenhaus Dormagen

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2021
• Primary Completion (Anticipated): August 31, 2022
• Study Completion (Anticipated): August 31, 2022

Study Registration Dates

• First Submitted: August 2, 2021
• First Submitted That Met QC Criteria: August 6, 2021
• First Posted (Actual): August 13, 2021

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 30, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: TOF 3D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No