Normal Vascular Doppler Pattern of Abdominal Organ in Children

May 3, 2022 updated by: Jin-Tae Kim, Seoul National University Hospital

The following ultrasonic findings are obtained at both time points before and after induction of anesthesia (T1) and after induction (T2) in normal children . Positive pressure ventilation (Tidal volume of 6-8 ml/kg and a positive exhalation pressure of 5 cmH2O) is applied after anesthetic induction.

  1. Inferior vena cava diameter and distensibility
  2. Hepatic vein Doppler
  3. Portal vein Doppler
  4. Splenic artery and vein Doppler
  5. Renal artery and vein Doppler Based on this, the reference values for Doppler findings before and after anesthesia in normal children are obtained.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

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 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children undergoing simple surgery

Exclusion Criteria:

  • thoracic/abdominal surgery
  • surgery for congenital heart disease
  • disease involving liver, kidney, spleen
  • vascular 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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Normal children
normal children undergoing simple surgery
Diagnostic test: abdominal Doppler
  1. Inferior vena cava diameter and distensibility
  2. Hepatic vein Doppler
  3. Portal vein Doppler
  4. Splenic artery and vein Doppler
  5. Renal artery and vein Doppler

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
portal vein flow velocity (cm/s) during self respiration
Time Frame: just before anesthesia induction (about 5 minutes before anesthetic induction)
just before anesthesia induction (about 5 minutes before anesthetic induction)
portal vein flow velocity (cm/s) during general anesthesia
Time Frame: during positive pressure ventilation (within 5 - 60 minutes after anesthetic induction)
during positive pressure ventilation (within 5 - 60 minutes after anesthetic induction)
splenic vein flow velocity (cm/s) during self respiration
Time Frame: just before anesthesia induction (about 5 minutes before anesthetic induction)
just before anesthesia induction (about 5 minutes before anesthetic induction)
inferior vena cava diameter (mm) during self respiration
Time Frame: just before anesthesia induction (about 5 minutes before anesthetic induction)
just before anesthesia induction (about 5 minutes before anesthetic induction)
inferior vena cava diameter (mm) during general anesthesia
Time Frame: during positive pressure ventilation (within 5 - 60 minutes after anesthetic induction)
during positive pressure ventilation (within 5 - 60 minutes after anesthetic induction)
hepatic vein flow velocity (cm/s) during self respiration
Time Frame: just before anesthesia induction (about 5 minutes before anesthetic induction)
just before anesthesia induction (about 5 minutes before anesthetic induction)
hepatic vein flow velocity (cm/s) during general anesthesia
Time Frame: during positive pressure ventilation (within 5 - 60 minutes after anesthetic induction)
during positive pressure ventilation (within 5 - 60 minutes after anesthetic induction)
renal artery/vein flow velocities (cm/s) during self respiration
Time Frame: just before anesthesia induction (about 5 minutes before anesthetic induction)
just before anesthesia induction (about 5 minutes before anesthetic induction)
renal artery/vein flow velocities (cm/s) during general anesthesia
Time Frame: during positive pressure ventilation (within 5 - 60 minutes after anesthetic induction)
during positive pressure ventilation (within 5 - 60 minutes after anesthetic induction)

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 (Actual)

March 28, 2022

Primary Completion (Anticipated)

December 30, 2022

Study Completion (Anticipated)

December 30, 2022

Study Registration Dates

First Submitted

January 17, 2022

First Submitted That Met QC Criteria

March 20, 2022

First Posted (Actual)

March 22, 2022

Study Record Updates

Last Update Posted (Actual)

May 5, 2022

Last Update Submitted That Met QC Criteria

May 3, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • H2105-151-1222

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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