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Ultrasound Assessment of the Inferior Vena Cava in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03948282
Recruitment Status : Completed
First Posted : May 13, 2019
Last Update Posted : November 6, 2019
Sponsor:
Information provided by (Responsible Party):
Alok Moharir, Nationwide Children's Hospital

Tracking Information
First Submitted Date May 10, 2019
First Posted Date May 13, 2019
Last Update Posted Date November 6, 2019
Actual Study Start Date July 31, 2019
Actual Primary Completion Date August 16, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 10, 2019)
IVC diameter [ Time Frame: Baseline ]
Measurement of the inferior vena cava via ultrasound using the right lateral view and the subxiphoid view.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Ultrasound Assessment of the Inferior Vena Cava in Children
Official Title Ultrasound Assessment of the Inferior Vena Cava in Children; Comparison of Sub-xiphoid and Right Lateral Coronal Views During Spontaneous Ventilation
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).
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Children undergoing elective dental surgery.
Condition Surgery
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 5, 2019)
51
Original Estimated Enrollment
 (submitted: May 10, 2019)
50
Actual Study Completion Date August 16, 2019
Actual Primary Completion Date August 16, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • History of significant pulmonary disease, cardiac disease, and laparotomy.
Sex/Gender
Sexes Eligible for Study: All
Ages 1 Year to 12 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03948282
Other Study ID Numbers STUDY00000316
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Alok Moharir, Nationwide Children's Hospital
Study Sponsor Alok Moharir
Collaborators Not Provided
Investigators Not Provided
PRS Account Nationwide Children's Hospital
Verification Date November 2019