NCT04093661

Brief Summary

As part of the clinical routine of the Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK), Charité - Universitätsmedizin Berlin at Campus Virchow-Klinikum intraoperative electroencephalography data and clinical routine data are recorded and evaluated in surgical children (\<=1 year).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2019

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

First Submitted

Initial submission to the registry

September 16, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

September 16, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 18, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2019

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

2 months

First QC Date

September 16, 2019

Last Update Submit

January 15, 2020

Conditions

Depth of Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Electroencephalography monitoring changes

    The primary objective of this study performed according to an observational post-ad-hoc design measures the perioperative EEG overall power signature. Approximately 150 children admitted from 06/2017 to 06/2019 to the Charité will be enrolled in the study. They are followed up until their discharge from the recovery room.

    06/2017 - 06/2019

Secondary Outcomes (4)

  • Anesthetic depth

    06/2017 - 06/2019

  • Medication

    06/2017 - 06/2019

  • Emergence Delirium

    06/2017 - 06/2019

  • Pain

    06/2017 - 06/2019

Other Outcomes (2)

  • Duration of anesthesia

    06/2017 - 06/2019

  • Type of surgery

    06/2017 - 06/2019

Study Arms (1)

Children below 1 year

Children \<= 1 year for elective surgery

Eligibility Criteria

Age1 Month - 12 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children \<= 1 year undergoing surgery procedure with Electroencephalography Monitoring.

You may qualify if:

  • Children \<= 1 year undergoing surgery procedure

You may not qualify if:

  • Incomplete patient record documentation
  • Pre-existing neurological/psychological conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK), Charité - Universitätsmedizin Berlin

Berlin, 13353, Germany

Location

Study Officials

  • Claudia Spies, MD, Prof.

    Department of Anesthesiology and Operative Intensive Care Medicine, Campus Charité Mitte and Campus Virchow-Klinikum, Charité - Universitätsmedizin Berlin

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK)

Study Record Dates

First Submitted

September 16, 2019

First Posted

September 18, 2019

Study Start

September 16, 2019

Primary Completion

November 29, 2019

Study Completion

November 29, 2019

Last Updated

January 18, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)