NCT03753217

Brief Summary

Quantium Medical Company has an ElectroEncephalograph-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
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2018

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 26, 2018

Completed
8 days until next milestone

Study Start

First participant enrolled

December 4, 2018

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2018

Completed
Last Updated

February 15, 2019

Status Verified

August 1, 2018

Enrollment Period

17 days

First QC Date

November 22, 2018

Last Update Submit

February 12, 2019

Conditions

General Anesthesia

Keywords

Anesthesia Monitoring

Outcome Measures

Primary Outcomes (2)

  • qCON monitoring during maintenance of anesthesia

    Measurement of qCON values during maintenance of anesthesia

    Up to 10 hours

  • BIS monitoring during maintenance of anesthesia

    Measurement of BIS values during maintenance of anesthesia

    Up to 10 hours

Secondary Outcomes (10)

  • 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

    One day

  • Burst Suppression ratio retrieved by qCON monitoring

    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 above 18 years,
  • 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 by intravenous drugs (propofol and remifentanil),
  • 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 monitors,
  • Patients having a contraindication to Propofol and/or to Remifentanil.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Foch

Suresnes, 92150, France

Location

Study Officials

  • Marc Fischler, MD PhD

    Hopital Foch

    STUDY DIRECTOR

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 22, 2018

First Posted

November 26, 2018

Study Start

December 4, 2018

Primary Completion

December 21, 2018

Study Completion

December 21, 2018

Last Updated

February 15, 2019

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)