NCT03066024

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
94

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 10, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 28, 2017

Completed
Last Updated

April 17, 2020

Status Verified

April 1, 2020

Enrollment Period

7 months

First QC Date

February 10, 2017

Last Update Submit

April 16, 2020

Conditions

Depth of Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Electroencephalography monitoring changes

    Up to the end of surgery

Secondary Outcomes (1)

  • Anesthetic depth

    Up to the end of surgery

Study Arms (1)

Children and adolescents

Children and adolescents for elective surgery

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Children and adolescents during anaesthesia / surgery procedure

You may qualify if:

  • Children and adolescents undergoing surgery procedure

You may not qualify if:

  • Neurosurgery
  • Pre-existing neurological conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité - University Medicine Belrin

Berlin, 13353, Germany

Location

Study Officials

  • Claudia Spies, MD, Prof.

    Charite University, Berlin, Germany

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Hospital director of the Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité - University Medicine Berlin

Study Record Dates

First Submitted

February 10, 2017

First Posted

February 28, 2017

Study Start

April 1, 2015

Primary Completion

November 1, 2015

Study Completion

December 1, 2015

Last Updated

April 17, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)