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

NCT ID: NCT05231525

Last Updated: 2022-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-09

Study Completion Date

2022-09-20

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Neuromuscular Residual Curarization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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WiTOF

Group Type EXPERIMENTAL

WiTOF

Intervention Type DEVICE

Data collection on the WiTOF monitor

TOFscan

Group Type ACTIVE_COMPARATOR

TOFscan

Intervention Type DEVICE

Data collection on the TOFscan monitor

Interventions

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WiTOF

Data collection on the WiTOF monitor

Intervention Type DEVICE

TOFscan

Data collection on the TOFscan monitor

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Poitiers University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthieu BOISSON

Role: PRINCIPAL_INVESTIGATOR

CHU de Poitiers FRANCE

Locations

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CHU de Poitiers

Poitiers, , France

Site Status

Countries

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France

Other Identifiers

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WiTOF

Identifier Type: -

Identifier Source: org_study_id

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