NCT05290168

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

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
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 22, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

March 28, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

May 5, 2022

Status Verified

May 1, 2022

Enrollment Period

9 months

First QC Date

January 17, 2022

Last Update Submit

May 3, 2022

Conditions

Normal Children

Outcome Measures

Primary Outcomes (9)

  • portal vein flow velocity (cm/s) during self respiration

    just before anesthesia induction (about 5 minutes before anesthetic induction)

  • portal vein flow velocity (cm/s) during general anesthesia

    during positive pressure ventilation (within 5 - 60 minutes after anesthetic induction)

  • splenic vein flow velocity (cm/s) during self respiration

    just before anesthesia induction (about 5 minutes before anesthetic induction)

  • inferior vena cava diameter (mm) during self respiration

    just before anesthesia induction (about 5 minutes before anesthetic induction)

  • inferior vena cava diameter (mm) during general anesthesia

    during positive pressure ventilation (within 5 - 60 minutes after anesthetic induction)

  • hepatic vein flow velocity (cm/s) during self respiration

    just before anesthesia induction (about 5 minutes before anesthetic induction)

  • hepatic vein flow velocity (cm/s) during general anesthesia

    during positive pressure ventilation (within 5 - 60 minutes after anesthetic induction)

  • renal artery/vein flow velocities (cm/s) during self respiration

    just before anesthesia induction (about 5 minutes before anesthetic induction)

  • renal artery/vein flow velocities (cm/s) during general anesthesia

    during positive pressure ventilation (within 5 - 60 minutes after anesthetic induction)

Study Arms (1)

Normal children

EXPERIMENTAL

normal children undergoing simple surgery

Diagnostic Test: abdominal Doppler

Interventions

abdominal DopplerDIAGNOSTIC_TEST

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

Normal children

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children undergoing simple surgery

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jin-Tae Kim

Seoul, South Korea

RECRUITING

Central Study Contacts

Jin-Tae Kim

CONTACT

82-2-2072-3661jintae73@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 17, 2022

First Posted

March 22, 2022

Study Start

March 28, 2022

Primary Completion

December 30, 2022

Study Completion

December 30, 2022

Last Updated

May 5, 2022

Record last verified: 2022-05

Locations

KR(1)