NCT07415603

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.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
35mo left

Started Jun 2026

Typical duration for all trials

Status
not yet recruiting

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

Study Progress6%
Jun 2026May 2029

First Submitted

Initial submission to the registry

February 10, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 17, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2029

Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

3 years

First QC Date

February 10, 2026

Last Update Submit

February 10, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (1)

Prone surgical patients

Other: Observation

Interventions

No intervention

Prone surgical patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing surgery at Nationwide Children's Hospital only.

You may qualify if:

  • Consenting ASA 1-4 patients
  • Undergoing a surgical procedure with general anesthesia that requires placement of an arterial cannula and prone positioning

You may not qualify if:

  • Patients in whom an arterial cannula is not indicated or cannot be placed
  • Patients undergoing a surgical procedure that does not require prone positioning

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Joseph Tobias, MD

    Nationwide Children's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief - Department of Anesthesiology & Pain Medicine

Study Record Dates

First Submitted

February 10, 2026

First Posted

February 17, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

May 31, 2029

Study Completion (Estimated)

May 31, 2029

Last Updated

February 17, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share