NCT05005676

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 13, 2021

Completed
18 days until next milestone

Study Start

First participant enrolled

August 31, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

1 year

First QC Date

August 2, 2021

Last Update Submit

March 30, 2022

Conditions

Assessment of a New AcceleromyographNeuromuscular Block

Outcome Measures

Primary Outcomes (1)

  • TOF-R 90%

    Difference of the 90% train-of-four (TOF) recovery time between both devices

    12 months

Secondary Outcomes (2)

  • repeatability (precision)

    12 months

  • bias and limits of agreement (Bland-Altman analysis)

    12 months

Study Arms (2)

adductor pollicis AP

EXPERIMENTAL

Measurement site: M.adductor pollicis of both arms.

Diagnostic Test: acceleromyography

Corrugator supercilii CS

EXPERIMENTAL

Measurement site: M. corrugator supercilii at both sides

Diagnostic Test: acceleromyography

Interventions

acceleromyographyDIAGNOSTIC_TEST

Simultaneous measurement of the time course of a neuromuscular block with 2 acceleromyographs

Corrugator supercilii CSadductor pollicis AP

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KKH Dormagen

Dormagen, D-41540, Germany

RECRUITING

Central Study Contacts

Stefan Soltesz, Prof.

CONTACT

00492133664500stefan.soltesz@kkh-ne.de

Günter K Noe, MD

CONTACT

00492133664600karl-guenter.noe@kkh-ne.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Stefan Soltesz

Study Record Dates

First Submitted

August 2, 2021

First Posted

August 13, 2021

Study Start

August 31, 2021

Primary Completion

August 31, 2022

Study Completion

August 31, 2022

Last Updated

March 31, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)