Comparison of Two Neuromuscular Monitors | NCT02350062

Studies
Comparison of Two Neuromuscular Monitors

NCT02350062

Sponsor

University Hospital, Caen

Status

Completed

Last Update Posted

Jan 29, 2015Estimated

Enrollment

17Actual

Phase

Not provided

Conditions

Neuromuscular Monitoring

Interventions

Not provided

Countries

Not provided

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

Jan 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Mar 2014Actual

Completion Date

Nov 2014Actual

First Submitted Date

Nov 27, 2014

First Submission Date that Met QC Criteria

Jan 28, 2015

First Posted Date

Jan 29, 2015Estimated

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

Jan 28, 2015

Last Update Posted Date

Jan 29, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Different neuromuscular monitors may be available in the same care structure. Two different monitors are available in the investigators' institution in the operative room and the recovery room. However, these two monitors have not been compared and may not be interchangeable. Starting the monitoring with one device and continuing with another device may be inaccurate and may lead to inadequate medical decisions. The investigators therefore conducted this observational study to compare the two devices available in our institution.

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

17Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to recover T4/T1 > 90%	After muscle relaxant injection, we measure the time needed for the muscular response to disappear and to completely recover during the operation (which takes in average 2 hours).	Time between muscle relaxant injection and: intubation; recovery of 4 responses on the train of four (TOF); recovery of T4/T1 >40%; recovery of T4/T1>90% average 2 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing vascular surgery under general anesthesia and requiring neuromuscular blockade for intubation or surgery

Exclusion Criteria:

Pregnancy or feeding
Any pathology or medication that may impair neuromuscular conduction or muscular response of the ulnar nerve stimulation
American Society of Anesthesiology [4] physical status
Allergy or contraindication of neuromuscular blocking agents

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing vascular surgery under general anesthesia and requiring neuromuscular blockade for intubation or surgery

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Georges Daccache, M.D	University Hospital, Caen	Principal Investigator

Locations

Not provided