NCT04070339

Brief Summary

We planned to evaluate cerebral blood flow and its association with age, blood pressure, and end tidal carbon dioxide in small pediatric using transfontanelle ultrasound during general anesthesia.

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
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

August 26, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

August 28, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

July 23, 2020

Status Verified

July 1, 2020

Enrollment Period

2.9 years

First QC Date

August 26, 2019

Last Update Submit

July 21, 2020

Conditions

Cerebral Blood Flow

Outcome Measures

Primary Outcomes (1)

  • cerebral blood flow

    from anesthetic induction to postanesthesia care unit discharge, an average of 3 hours

Interventions

transfontanelle ultrasoundOTHER

cerebral blood flow investigation using transfontanelle ultrasound

Eligibility Criteria

AgeUp to 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

pediatrics including preterm neonates undergoing general anesthesia

You may qualify if:

  • pediatric patients undergoing general anesthesia

You may not qualify if:

  • patients with hydrocephalus, brain tumor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jin-Tae Kim

Seoul, South Korea

RECRUITING

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

August 26, 2019

First Posted

August 28, 2019

Study Start

August 28, 2019

Primary Completion

August 1, 2022

Study Completion

August 1, 2022

Last Updated

July 23, 2020

Record last verified: 2020-07

Locations

KR(1)