NCT05391282

Brief Summary

Little is known about how implementation of prone position contributes to general anesthesia-induced decrease in cerebral blood flow in infants. The investigators investigated this question in participants undergoing untethering, hypothesizing that cardiorespiratory changes during this procedure would reduce cerebral perfusion.

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
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2022

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

May 20, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

May 23, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 25, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2023

Completed
Last Updated

May 31, 2022

Status Verified

May 1, 2022

Enrollment Period

1.6 years

First QC Date

May 20, 2022

Last Update Submit

May 24, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Changes of internal carotid artery blood flow velocity

    from induction of anesthesia to end of operation, about 3 hours

Interventions

Transfontanel ultrasound assessment before and after prone positioning

Eligibility Criteria

AgeUp to 15 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

pediatric neurosurgical patients

You may qualify if:

  • pediatric neurosurgical patients receiving surgery under prone position

You may not qualify if:

  • patients diagnosed as hydrocephalus
  • premature closure of fontanelle
  • patients diagnosed as patent ductus arteriosus or other congenital heart disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul national university hospital

Seoul, South Korea

Location

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

May 20, 2022

First Posted

May 25, 2022

Study Start

May 23, 2022

Primary Completion

December 23, 2023

Study Completion

December 23, 2023

Last Updated

May 31, 2022

Record last verified: 2022-05

Locations