Electroencephalogram Dynamics in Children During Differen... | NCT03066024

Studies
Electroencephalogram Dynamics in Children During Different Levels of Anesthetic Depth

NCT03066024

Sponsor

Charite University, Berlin, Germany

Status

Completed

Last Update Posted

Apr 17, 2020Actual

Enrollment

94Actual

Phase

Not provided

Conditions

Depth of Anesthesia

Interventions

Not provided

Countries

Germany

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

Apr 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2015Actual

Primary Completion Date

Nov 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Feb 10, 2017

First Submission Date that Met QC Criteria

Feb 22, 2017

First Posted Date

Feb 28, 2017Actual

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

Apr 16, 2020

Last Update Posted Date

Apr 17, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Claudia Spies, Hospital director of the Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité - University Medicine Berlin, Charite University, Berlin, GermanyPrincipal Investigator

Lead Sponsor

Charite University, Berlin, GermanyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

As part of the clinical routine of the Department of Anesthesiology and Intensive Care Medicine CVK/CCM in the Charité - University Medicine Berlin intraoperative electroencephalography data and clinical routine data are recorded and evaluated in surgical children and adolescents according to different age groups.

Detailed Description

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

94Actual

Label	Type	Description	Intervention Names
Children and adolescents		Children and adolescents for elective surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Electroencephalography monitoring changes		Up to the end of surgery

Secondary Outcomes

Measure	Description	Time Frame
Anesthetic depth		Up to the end of surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children and adolescents undergoing surgery procedure

Exclusion Criteria:

Neurosurgery
Pre-existing neurological conditions

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Children and adolescents during anaesthesia / surgery procedure

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Claudia Spies, MD, Prof.	Charite University, Berlin, Germany	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité - University Medicine Belrin		Berlin		13353	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided