NCT04826146

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

2 active sites

Status
unknown

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

Study Start

First participant enrolled

July 1, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

September 9, 2021

Status Verified

September 1, 2021

Enrollment Period

1.4 years

First QC Date

March 21, 2021

Last Update Submit

September 1, 2021

Conditions

AnesthesiaAnesthesia AwarenessNociceptive PainPediatric ALLSurgeryPain

Outcome Measures

Primary Outcomes (1)

  • Correlation of qCOX and BIS values

    Both values are correlated by a blind investigator

    prospective data acquisition through study completion, an average of 1 year

Secondary Outcomes (1)

  • Correlation of qNOX and MOAA/S values

    prospective data acquisition through study completion, an average of 1 year

Study Arms (1)

CONOX

Patients are monitored with BIS and CONOX

Device: Validation of qCON versus BIS

Interventions

Validation of qCON versus BISDEVICE

Correlation between qCON and BIS values (main outcome) and qNOX and MOAA/S scale are determined

Also known as: Validation of qNOX Vs MOAA/S Scale
CONOX

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • General Anesthesia using propofol, sevoflurane or desflurane
  • ASA I - IV
  • Surgical procedure longer than 60 minutes

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Universitario de Santiago de Compostela (CHUS)

Santiago de Compostela, Spain

Location

MeSH Terms

Conditions

Intraoperative AwarenessNociceptive PainPrecursor Cell Lymphoblastic Leukemia-LymphomaPain

Condition Hierarchy (Ancestors)

Intraoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and SymptomsLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 21, 2021

First Posted

April 1, 2021

Study Start

July 1, 2020

Primary Completion

December 1, 2021

Study Completion

December 30, 2021

Last Updated

September 9, 2021

Record last verified: 2021-09

Locations

ES(2)