Pediatric Validation of CONOX Monitor During Surgery

September 1, 2021 updated by: Patricio Gonzalez Pizarro

Monitoring the Depth of Anesthesia Using the qCON and qNOX Indices During Pediatric Surgery: a Multi-centre Study

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

65

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Santiago De Compostela, Spain
        • Hospital Universitario de Santiago de Compostela (CHUS)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children undergoing general anesthesia for a surgical procedure longer than 60 minutes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of qCOX and BIS values
Time Frame: prospective data acquisition through study completion, an average of 1 year
Both values are correlated by a blind investigator
prospective data acquisition through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of qNOX and MOAA/S values
Time Frame: prospective data acquisition through study completion, an average of 1 year
Both values are correlated by a blind investigator
prospective data acquisition through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Patricio Gonzalez Pizarro

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2020

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 30, 2021

Study Registration Dates

First Submitted

March 21, 2021

First Submitted That Met QC Criteria

March 29, 2021

First Posted (Actual)

April 1, 2021

Study Record Updates

Last Update Posted (Actual)

September 9, 2021

Last Update Submitted That Met QC Criteria

September 1, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI-3871

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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