- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07415603
PPV vs PVI in the Supine and Prone Position
Variability and Correlation of the Pulse Pressure Variability (PPV) and the Plethysmography Variability Index (PVI) in the Supine and Prone Position
This is a prospective study that will record the Pulse Pressure Variability (PPV) from the arterial line and Plethysmography Variability Index (PVI) from the pulse oximeter while the patient is in the supine position and then again in the prone position. There will be no change in anesthetic care based on the study protocol.
The primary objective of this study is to evaluate the changes in PVI and PPV when changing from the supine and prone position in pediatric-aged patients.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Julie Rice-Weimer, BSN
- Phone Number: 614-355-3142
- Email: Julie.Rice-Weimer@nationwidechildrens.org
Study Contact Backup
- Name: Catherine Roth, MPH
- Email: Catherine.Roth@nationwidechildrens.org
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Consenting ASA 1-4 patients
- Undergoing a surgical procedure with general anesthesia that requires placement of an arterial cannula and prone positioning
Exclusion Criteria:
- Patients in whom an arterial cannula is not indicated or cannot be placed
- Patients undergoing a surgical procedure that does not require prone positioning
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Prone surgical patients
|
No intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PPV Supine
Time Frame: Once a minute for 5 minutes
|
Pulse Pressure Variability (PPV) recorded from the arterial line while supine.
|
Once a minute for 5 minutes
|
|
PVI Supine
Time Frame: Once a minute for 5 minutes
|
Plethysmography Variability Index (PVI) recorded from the pulse oximeter while supine.
|
Once a minute for 5 minutes
|
|
PPV Prone
Time Frame: Once a minute for 5 minutes
|
Pulse Pressure Variability (PPV) recorded from the arterial line while prone.
|
Once a minute for 5 minutes
|
|
PVI Prone
Time Frame: Once a minute for 5 minutes
|
Plethysmography Variability Index (PVI) recorded from the pulse oximeter while prone.
|
Once a minute for 5 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Joseph Tobias, MD, Nationwide Children's Hospital
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00005745
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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