Internal Carotid Artery Blood Flow in Infants With Prone Position

May 24, 2022 updated by: Eun-hee Kim, Seoul National University Hospital

A Study on Internal Carotid Artery Blood Flow Velocity Changes in Prone, Head Tilt and Trendelenberg Position in Infants: an Observational Study Using Transfontanel Ultrasound

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

pediatric neurosurgical patients

Description

Inclusion Criteria:

  • pediatric neurosurgical patients receiving surgery under prone position

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes of internal carotid artery blood flow velocity
Time Frame: from induction of anesthesia to end of operation, about 3 hours
from induction of anesthesia to end of operation, about 3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 23, 2022

Primary Completion (Anticipated)

December 23, 2023

Study Completion (Anticipated)

December 23, 2023

Study Registration Dates

First Submitted

May 20, 2022

First Submitted That Met QC Criteria

May 20, 2022

First Posted (Actual)

May 25, 2022

Study Record Updates

Last Update Posted (Actual)

May 31, 2022

Last Update Submitted That Met QC Criteria

May 24, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 2204-162-1320

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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