Normal Vascular Doppler Pattern of Abdominal Organ in Children

Normal Children Clinical Trial

Official title:

Normal Vascular Doppler Pattern of Abdominal Organ in Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05290168
• Other study ID #: H2105-151-1222
• Status: Recruiting
• Phase: N/A
• Start date: March 28, 2022
• Est. completion date: December 30, 2022

Study information

• Verified date: May 2022
• Source: Seoul National University Hospital
• Contact: Jin-Tae Kim
• Phone: 82-2-2072-3661
• Email: jintae73[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• Children undergoing simple surgery

Exclusion Criteria:

• thoracic/abdominal surgery

• surgery for congenital heart disease

• disease involving liver, kidney, spleen

• vascular disease

Related Conditions & MeSH terms

• Normal Children

Intervention

Diagnostic Test:
• abdominal Doppler
Inferior vena cava diameter and distensibility Hepatic vein Doppler Portal vein Doppler Splenic artery and vein Doppler Renal artery and vein Doppler

Locations

Country	Name	City	State
Korea, Republic of	Jin-Tae Kim	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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