NCT03948282

Brief Summary

This is a prospective, non-blinded observational study to compare measurement of inferior vena cava (IVC) dimensions with two placement sites of the ultrasound probe (sub-xiphoid and the side or right lateral position).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 10, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 13, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

July 31, 2019

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2019

Completed
Last Updated

November 6, 2019

Status Verified

November 1, 2019

Enrollment Period

16 days

First QC Date

May 10, 2019

Last Update Submit

November 5, 2019

Conditions

Surgery

Outcome Measures

Primary Outcomes (1)

  • IVC diameter

    Measurement of the inferior vena cava via ultrasound using the right lateral view and the subxiphoid view.

    Baseline

Eligibility Criteria

Age1 Year - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children undergoing elective dental surgery.

You may qualify if:

  • ASA 1-2 patients scheduled for elective dental surgery under general anesthesia.

You may not qualify if:

  • History of significant pulmonary disease, cardiac disease, and laparotomy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Pediatric Anesthesiologist

Study Record Dates

First Submitted

May 10, 2019

First Posted

May 13, 2019

Study Start

July 31, 2019

Primary Completion

August 16, 2019

Study Completion

August 16, 2019

Last Updated

November 6, 2019

Record last verified: 2019-11

Locations

US(1)