Comparison of Two Electroencephalograms (EEG) Monitors in... | NCT03359512

Studies
Comparison of Two Electroencephalograms (EEG) Monitors in Patients Undergoing General Anesthesia With Sevoflurane

NCT03359512

Sponsor

Hopital Foch

Status

Completed

Last Update Posted

Aug 24, 2018Actual

Enrollment

46Actual

Phase

Not Applicable

Conditions

General Anesthesia

Interventions

qCON monitor

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

ID	Type	Description	Link
2016-A01088-43	Other Identifier	ANSM

Status Module

Record Verification Date

Nov 2017

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

Nov 21, 2017Actual

Primary Completion Date

Mar 16, 2018Actual

Completion Date

Mar 16, 2018Actual

First Submitted Date

Nov 6, 2017

First Submission Date that Met QC Criteria

Nov 30, 2017

First Posted Date

Dec 2, 2017Actual

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

Aug 23, 2018

Last Update Posted Date

Aug 24, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Quantium Medical Company has an ElectoEcenphalograph-based (EEG-based) algorithm with two outputs: qCON for unconsciousness and qNOX for anti-nociception. qCON, is designed to provide information about the depth of the hypnotic state, similar to that provided by the BIS™.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

46Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
qCON monitor	Experimental	Simultaneous measurement of BIS and qCON	Device: qCON monitor

Interventions

Name	Type	Description	Arm Group Labels	Other Names
qCON monitor	Device	supervision by qCON monitor of the depth of anesthesia	qCON monitor

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
qCON monitoring during maintenance of anesthesia	Measurement of qCON values	up to 10 hours

Secondary Outcomes

Measure	Description	Time Frame
BIS monitoring during maintenance of anesthesia	Measurement of BIS values each 5 seconds during maintenance of anesthesia	One day
qCON monitoring during induction of anesthesia	Measurement of qCON values each 5 seconds during induction of anesthesia

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients affiliated to a national insurance scheme or benefiting from such a program
Patients having given their written consent.
Patients that must benefit from a general anesthesia with the aim of a surgical act of a duration of at least one hour
Patients that must benefit from a general anesthesia including a maintenance by the sevoflurane.
For the patients taken care in ambulatory surgery, having a telephone and agreeing to communicate their phone number

Exclusion Criteria:

Pregnant or breast-feeding Women
Patients having a limit of use of the Bispectral Index (BIS) or qCON monitor ,
Patients having a contraindication in the propofol.
Patients taken care in ambulatory surgery who could not be contacted within 24 hours following the surgical operation;

Accepts Healthy Volunteers

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Faiz Sofian, MD	Hopital Foch	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hopital Foch		Suresnes		92150	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided