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Pediatric Validation of CONOX Monitor During Surgery

Sponsor
Patricio Gonzalez Pizarro (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04826146
Collaborator
(none)
65
Enrollment
2
Locations
18
Anticipated Duration (Months)
32.5
Patients Per Site
1.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Pediatric Validation of CONOX Monitoring device (qCON and qNOX indices) for anesthesia depth during surgery

Condition or Disease Intervention/Treatment Phase
  • Device: Validation of qCON versus BIS

Study Design

Study Type:
Observational
Anticipated Enrollment :
65 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Monitoring the Depth of Anesthesia Using the qCON and qNOX Indices During Pediatric Surgery: a Multi-centre Study
Actual Study Start Date :
Jul 1, 2020
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 30, 2021

Arms and Interventions

Arm Intervention/Treatment
CONOX

Patients are monitored with BIS and CONOX

Device: Validation of qCON versus BIS
Correlation between qCON and BIS values (main outcome) and qNOX and MOAA/S scale are determined
Other Names:
  • Validation of qNOX Vs MOAA/S Scale

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Correlation of qCOX and BIS values [prospective data acquisition through study completion, an average of 1 year]

      Both values are correlated by a blind investigator

    Secondary Outcome Measures

    1. Correlation of qNOX and MOAA/S values [prospective data acquisition through study completion, an average of 1 year]

      Both values are correlated by a blind investigator

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • General Anesthesia using propofol, sevoflurane or desflurane

    • ASA I - IV

    • Surgical procedure longer than 60 minutes

    Exclusion Criteria:

    • Neurological disorders

    • Inability to correctly place BIS and CONOX probes in forehead

    • Pregnancy

    • Active prescription for drugs involving chronic pain and / or central nervous system

    • Hemodynamic instability

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Universitario La Paz Madrid Spain 28046
    2 Hospital Universitario de Santiago de Compostela (CHUS) Santiago De Compostela Spain

    Sponsors and Collaborators

    • Patricio Gonzalez Pizarro

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Patricio Gonzalez Pizarro, Principal Investigator, Hospital Universitario La Paz
    ClinicalTrials.gov Identifier:
    NCT04826146
    Other Study ID Numbers:
    • PI-3871
    First Posted:
    Apr 1, 2021
    Last Update Posted:
    Sep 9, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Nociceptive Pain
    Intraoperative Awareness

    Study Results

    No Results Posted as of Sep 9, 2021