PPV vs PVI in the Supine and Prone Position | NCT07415603

Studies
PPV vs PVI in the Supine and Prone Position

NCT07415603

Sponsor

Joseph D. Tobias

Status

Not yet recruiting

Last Update Posted

Feb 17, 2026Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Surgeries Undergoing General Anesthesia

Interventions

Observation

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2026Estimated

Primary Completion Date

May 31, 2029Estimated

Completion Date

May 31, 2029Estimated

First Submitted Date

Feb 10, 2026

First Submission Date that Met QC Criteria

Feb 10, 2026

First Posted Date

Feb 17, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 10, 2026

Last Update Posted Date

Feb 17, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Joseph D. Tobias, Chief - Department of Anesthesiology & Pain Medicine, Nationwide Children's HospitalSponsor-Investigator

Lead Sponsor

Joseph D. TobiasOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Prone surgical patients			Other: Observation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Observation	Other	No intervention	Prone surgical patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PPV Supine	Pulse Pressure Variability (PPV) recorded from the arterial line while supine.	Once a minute for 5 minutes
PVI Supine	Plethysmography Variability Index (PVI) recorded from the pulse oximeter while supine.	Once a minute for 5 minutes
PPV Prone	Pulse Pressure Variability (PPV) recorded from the arterial line while prone.	Once a minute for 5 minutes
PVI Prone	Plethysmography Variability Index (PVI) recorded from the pulse oximeter while prone.	Once a minute for 5 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients undergoing surgery at Nationwide Children's Hospital only.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Julie Rice-Weimer, BSN	Contact	614-355-3142		julie.rice-weimer@nationwidechildrens.org
Catherine Roth, MPH	Contact			catherine.roth@nationwidechildrens.org

Overall Officials

Name	Affiliation	Role
Joseph Tobias, MD	Nationwide Children's Hospital	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019370	Observation

Ancestor Terms

ID	Term
D008722	Methods
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided