NCT04134221

Brief Summary

Little is known about how general anesthesia-induced decrease in cerebral blood flow in pediatric moyamoya pateints. We investigated this question in patients undergoing moyamoya surgery, hypothesizing that cardiorespiratory changes during this procedure would reduce cerebral perfusion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2019

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

October 18, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

October 18, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 22, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 17, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2021

Completed
Last Updated

April 21, 2021

Status Verified

April 1, 2021

Enrollment Period

1.3 years

First QC Date

October 18, 2019

Last Update Submit

April 19, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Internal carotid artery blood flow velocity

    ultrasound assessment of internal carotid artery blood flow velocity

    from anesthetic induction to end of surgery, an average of 5 hours

Interventions

Ultrasound assessmentDIAGNOSTIC_TEST

Ultrasound assessment of internal carotid artery blood flow

Eligibility Criteria

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

pediatric Moyamoya disease patients

You may qualify if:

  • pediatric patients undergoing encephaloduroarteriosynangiosis surgery for moyamoya disease

You may not qualify if:

  • cutaneous lesion on the neck

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hee-Soo Kim

Seoul, Soul-t'ukpyolsi, 03080, South Korea

Location

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

October 18, 2019

First Posted

October 22, 2019

Study Start

October 18, 2019

Primary Completion

February 17, 2021

Study Completion

February 17, 2021

Last Updated

April 21, 2021

Record last verified: 2021-04

Locations