Surgeries Undergoing General AnesthesiaNCT07415603
PPV vs PVI in the Supine and Prone Position
An observational study of Surgeries Undergoing General Anesthesia, run by Joseph D. Tobias at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Surgeries Undergoing General Anesthesia
- What is being tested?
- Observation
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2026to 31 May 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing surgery at Nationwide Children's Hospital only.
Who may be able to join
- Consenting ASA 1-4 patients
- Undergoing a surgical procedure with general anesthesia that requires placement of an arterial cannula and prone positioning
Who cannot join
- Patients in whom an arterial cannula is not indicated or cannot be placed
- Patients undergoing a surgical procedure that does not require prone positioning
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: 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.
- Conditions
- Surgeries Undergoing General Anesthesia
- Being tested
- Observation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Prone surgical patients | Not described Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
PPV Supine
Pulse Pressure Variability (PPV) recorded from the arterial line while supine.
Measured: Once a minute for 5 minutes
PVI Supine
Plethysmography Variability Index (PVI) recorded from the pulse oximeter while supine.
Measured: Once a minute for 5 minutes
PPV Prone
Pulse Pressure Variability (PPV) recorded from the arterial line while prone.
Measured: Once a minute for 5 minutes
PVI Prone
Plethysmography Variability Index (PVI) recorded from the pulse oximeter while prone.
Measured: Once a minute for 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start9 Jul 2026
- Primary completion31 May 2029 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgeries Undergoing General AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joseph D. Tobias
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joseph D. Tobias, Nationwide Children's Hospital
- Investigators
- Joseph Tobias, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07415603
- Sponsor's protocol ID
- STUDY00005745
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Variability and Correlation of the Pulse Pressure Variability (PPV) and the Plethysmography Variability Index (PVI) in the Supine and Prone Position
- ClinicalTrials.gov ID
- NCT07415603
- Acronym / sponsor ID
- STUDY00005745
- Conditions
- Surgeries Undergoing General Anesthesia
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Joseph D. TobiasUniversity, hospital or other
- Study start
- 9 Jul 2026 (actual)
- Primary completion
- 31 May 2029 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prone surgical patients | – | Other: Observation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing surgery at Nationwide Children's Hospital only.
Key inclusion criteria (2 listed)
- Consenting ASA 1-4 patients
- Undergoing a surgical procedure with general anesthesia that requires placement of an arterial cannula and prone positioning
Key exclusion criteria (2 listed)
- Patients in whom an arterial cannula is not indicated or cannot be placed
- Patients undergoing a surgical procedure that does not require prone positioning
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationNo intervention | Other | Prone surgical patients |
Primary outcome
PPV Supine
Time frame: Once a minute for 5 minutes
Pulse Pressure Variability (PPV) recorded from the arterial line while supine.
PVI Supine
Time frame: Once a minute for 5 minutes
Plethysmography Variability Index (PVI) recorded from the pulse oximeter while supine.
PPV Prone
Time frame: Once a minute for 5 minutes
Pulse Pressure Variability (PPV) recorded from the arterial line while prone.
PVI Prone
Time frame: Once a minute for 5 minutes
Plethysmography Variability Index (PVI) recorded from the pulse oximeter while prone.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joseph Tobias, MD principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgeries Undergoing General Anesthesia, run by Joseph D. Tobias at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PPV Supine (time frame: Once a minute for 5 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.