NCT03359512

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™.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2017

Completed
15 days until next milestone

Study Start

First participant enrolled

November 21, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 2, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2018

Completed
Last Updated

August 24, 2018

Status Verified

November 1, 2017

Enrollment Period

4 months

First QC Date

November 6, 2017

Last Update Submit

August 23, 2018

Conditions

General Anesthesia

Keywords

anesthesia monitoring

Outcome Measures

Primary Outcomes (1)

  • qCON monitoring during maintenance of anesthesia

    Measurement of qCON values

    up to 10 hours

Secondary Outcomes (10)

  • BIS monitoring during maintenance of anesthesia

    One day

  • qCON monitoring during induction of anesthesia

    One day

  • BIS monitoring during induction of anesthesia

    One day

  • qCON monitoring during recovery of anesthesia

    One day

  • BIS monitoring during recovery of anesthesia during recovery of anesthesia

    One day

  • +5 more secondary outcomes

Study Arms (1)

qCON monitor

EXPERIMENTAL

Simultaneous measurement of BIS and qCON

Device: qCON monitor

Interventions

qCON monitorDEVICE

supervision by qCON monitor of the depth of anesthesia

qCON monitor

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Foch

Suresnes, 92150, France

Location

Study Officials

  • Faiz Sofian, MD

    Hopital Foch

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2017

First Posted

December 2, 2017

Study Start

November 21, 2017

Primary Completion

March 16, 2018

Study Completion

March 16, 2018

Last Updated

August 24, 2018

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)