Study Stopped
Recruitment was too slow and data collected would not add to already published studies.
A Prospective Investigation of Pleth Variability Index (PVI) as a Dynamic Parameter of Fluid Responsiveness in Children
1 other identifier
observational
9
1 country
1
Brief Summary
This study is designed to investigate the ability of pleth variability index (PVI) to non-invasively predict fluid responsiveness in mechanically ventilated children. Patients undergoing atrial septal defect (ASD) repair in the cardiac catheterization suite will be recruited for this study. These patients are ideal candidates because very few deviations will be made from standard clinical practice. All patients will already be under general anesthesia, mechanically ventilated, monitored with pulse oximetry, and provided with intravenous fluid to compensate for their nil per os (NPO) fluid deficit. The only deviation from clinical practice will include an abbreviated echocardiographic exam, application of the Masimo pulse oximeter, and measurement of CO via a thermodilution catheter by the interventional cardiologist.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2015
Typical duration for all trials
1 active site
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
October 23, 2014
CompletedFirst Posted
Study publicly available on registry
October 28, 2014
CompletedStudy Start
First participant enrolled
February 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 7, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2018
CompletedOctober 18, 2018
October 1, 2018
2.4 years
October 23, 2014
October 17, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Pleth Variability Index
Change in Pleth Variability Index following fluid bolus of 0.9% normal saline 10 mL/kg over 10 minutes, measured by Masimo Radical-7 monitor.
10 minutes
Secondary Outcomes (2)
Change in Cardiac Output
10 minutes
Change in Stroke Volume
10 mins
Study Arms (1)
Cardiac catheterization
Patients with a diagnosis of atrial septal defect who are having a cardiac catheterization.
Interventions
Fluid bolus of 0.9% normal saline 10 mL/kg over 10 minutes
Eligibility Criteria
Children undergoing cardiac catheterization for atrial septal defect.
You may qualify if:
- Children undergoing cardiac catheterization who will have normal (non-shunted) physiology at the conclusion of the procedure.
You may not qualify if:
- Patients with additional congenital heart abnormalities, cardiac arrhythmias, ventricular dysfunction, and known pulmonary disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Brian Schlosslead
Study Sites (1)
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brian Schloss, MD
Nationwide Children's Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
October 23, 2014
First Posted
October 28, 2014
Study Start
February 1, 2015
Primary Completion
July 7, 2017
Study Completion
May 31, 2018
Last Updated
October 18, 2018
Record last verified: 2018-10