Comparison of the TOFScan and the WiTOF During Recovery of Neuromuscular Function

November 30, 2022 updated by: Poitiers University Hospital

Recovery Evaluation of Two Neuromuscular Blockade Monitoring Devices on Abductor Pollicis Muscle, the TOFScan and the Wireless WiTOF

The purpose of this study is to compare two neuromuscular blockade monitors on recovery from an ATRACURIUM intra veinous injection for surgery. The TOFscan, a wired connected monitors and the WiTOF, a wireless connected monitor.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The secondary objective will be to compare the performance of the two monitors on the abductor pollicis muscle with all the curarisation parameters (TOF, PTC, T4/T1R) and to assess interference occuring during the surgery which could limit the usage of a wireless monitor.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Poitiers, France, 86021
        • CHU de Poitiers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All programmed surgery with intraveinous injection of ATRACURIUM
  • American society of anesthesiology patient score of I, II or III
  • Patient being free of tutorship or curatorship
  • Acceptance of the patient after clear and loyal information

Exclusion Criteria:

  • Surgery without access simultaneously to the two arms
  • Emergency surgery
  • Rapid sequence induction
  • Usage of an other curare than ATRACURIUM
  • Contraindication on ATRACURIUM usage
  • Patient with pace maker
  • Patient with Arné score > or = to 11
  • Patient without social security coverage
  • Pregnant of breastfeeding women
  • Patient under social protection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: WiTOF
Device: WiTOF
Data collection on the WiTOF monitor
Active Comparator: TOFscan
Device: TOFscan
Data collection on the TOFscan monitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the neuromuscular blockade recovery after intraveinous injection of atracurium with 2 differents monitors.
Time Frame: During the whole period of the surgical operation maximum 8 hours
Comparison on the obtention delay for the T4/T1 ratio superior ou equal to 90% beetween the WiTOF and the TOFScan
During the whole period of the surgical operation maximum 8 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the performance of the monitors for the follow up of neuromuscular recovery
Time Frame: During the whole period of the surgical operation maximum 8 hours
Comparison of neuromuscular blockade parameters obtained with the WiTOF and the TOFScan (TOF, PTC, T4/1R)
During the whole period of the surgical operation maximum 8 hours
Number and duration of perturbation from the surgical environnement that could limit the usage of a wireless monitor
Time Frame: During the whole period of the surgical operation maximum 8 hours
Assess what could perturbate the data collection on the wireless monitor
During the whole period of the surgical operation maximum 8 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poitiers University Hospital

Investigators

  • Principal Investigator: Matthieu BOISSON, CHU de Poitiers FRANCE

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2022

Primary Completion (Actual)

June 20, 2022

Study Completion (Actual)

September 20, 2022

Study Registration Dates

First Submitted

January 5, 2022

First Submitted That Met QC Criteria

February 7, 2022

First Posted (Actual)

February 9, 2022

Study Record Updates

Last Update Posted (Actual)

December 1, 2022

Last Update Submitted That Met QC Criteria

November 30, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • WiTOF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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