Comparison of the TOFscan and the TetraGraph During Recov... | NCT04816539

Studies
Comparison of the TOFscan and the TetraGraph During Recovery of Neuromuscular Function

NCT04816539

Sponsor

Central Hospital, Nancy, France

Status

Unknown status

Last Update Posted

Mar 25, 2021Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Neuromuscular Blockade

Interventions

TetraGraph

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 15, 2021Estimated

Primary Completion Date

Apr 30, 2021Estimated

Completion Date

Apr 30, 2021Estimated

First Submitted Date

Mar 23, 2021

First Submission Date that Met QC Criteria

Mar 23, 2021

First Posted Date

Mar 25, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 23, 2021

Last Update Posted Date

Mar 25, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Assess the values of train-of-four ratios with the TetraGraph and thoses obtained with the TOFscan during recovery of neuromusculat function in surgical patients who have been administred rocuronium.

Primary outcome : value of TOFratio with the TetraGraph when TOFratio of TOFscan is greater than or equal to 90% Pilot study : no hypothesis

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TetraGraph	Device	Use of two monitoring devices of neuromuscular function during surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Train-of-four ratios	Value of TOFratio with TetraGraph when TOFratio with TOFscan is greater than or equal to 90% (first value of three greater than or equal to 90%)	baseline (J0)

Secondary Outcomes

Measure	Description	Time Frame
Train-of-four ratios	Value of TOFratio with TetraGraph when TOFratio with TOFscan is greater than or equal to 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80% and eventually 100%	baseline (J0)
Train-of-four ratios

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age greater than or equal to 18 years old
patients willing to participate and provide an informed consent
elective surgical procedures, without emergency, administration of rocuronium for neuromuscular blockade, and recovery of complete neuromuscular function at the end of the surgery

Exclusion Criteria:

patients with unilateral disorders, such as stroke, carpal tunnel syndrome, broken wrist with nerve damage, Dupuytren contracture, or similar wrist injury
patients with systemic neuromuscular diseases such as myasthenia gravis
renal insufficiency or renal failure
significant liver disease
patients having surgery that would involve prepping the arm into the sterile field
allergy to rocuronium

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing an electrive surgical procedure with non emergency and that requires use of Rocuronium, and willing to participate and provide an informed consent

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Claude Meistelman	Contact	0383153464		c.meistelman@chru-nancy.fr

Overall Officials

Name	Affiliation	Role
Claude Meistelman	Central Hospital, Nancy, France	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chu Nancy		Vandœuvre-lès-Nancy		54500	France