Pediatric Validation of CONOX Monitor During Surgery | NCT04826146

Studies
Pediatric Validation of CONOX Monitor During Surgery

NCT04826146

Sponsor

Patricio Gonzalez Pizarro

Status

Unknown status

Last Update Posted

Sep 9, 2021Actual

Enrollment

65Estimated

Phase

Not provided

Conditions

Anesthesia
Anesthesia Awareness
Nociceptive Pain
Pediatric ALL
Surgery
Pain

Interventions

Validation of qCON versus BIS

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2020Actual

Primary Completion Date

Dec 1, 2021Estimated

Completion Date

Dec 30, 2021Estimated

First Submitted Date

Mar 21, 2021

First Submission Date that Met QC Criteria

Mar 29, 2021

First Posted Date

Apr 1, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 1, 2021

Last Update Posted Date

Sep 9, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Patricio Gonzalez Pizarro, Principal Investigator, Hospital Universitario La PazSponsor-Investigator

Lead Sponsor

Patricio Gonzalez PizarroOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

65Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CONOX		Patients are monitored with BIS and CONOX	Device: Validation of qCON versus BIS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Validation of qCON versus BIS	Device	Correlation between qCON and BIS values (main outcome) and qNOX and MOAA/S scale are determined	CONOX

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Universitario La Paz		Madrid		28046	Spain
Hospital Universitario de Santiago de Compostela (CHUS)

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D058926	Intraoperative Awareness
D059226	Nociceptive Pain
D054198	Precursor Cell Lymphoblastic Leukemia-Lymphoma
D010146	Pain

Ancestor Terms

ID	Term
D007431	Intraoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009461	Neurologic Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided