Evaluation of the New Acceleromyograph TOF 3D

Neuromuscular Block Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05005676
• Other study ID #: TOF 3D
• Status: Recruiting
• Phase: N/A
• Start date: August 31, 2021
• Est. completion date: August 31, 2022

Study information

• Verified date: March 2022
• Source: Kreiskrankenhaus Dormagen
• Contact: Stefan Soltesz, Prof.
• Phone: 00492133664500
• Email: stefan.soltesz[@]kkh-ne.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuromuscular Block

Intervention

Diagnostic Test:
• acceleromyography
Simultaneous measurement of the time course of a neuromuscular block with 2 acceleromyographs

Locations

Country	Name	City	State
Germany	KKH Dormagen	Dormagen

Sponsors (1)

Lead Sponsor	Collaborator
Kreiskrankenhaus Dormagen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TOF-R 90%	Difference of the 90% train-of-four (TOF) recovery time between both devices	12 months
Secondary	repeatability (precision)	Variance of 10 consecutive measurements around a linear regression line for each device	12 months
Secondary	bias and limits of agreement (Bland-Altman analysis)	Difference between both devices against the average of both measurements (bias +- 2SD)	12 months