Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-31 @ 11:20 AM
Study NCT ID:
NCT07415603
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-17
First Post:
2026-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PPV vs PVI in the Supine and Prone Position
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2029-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-10', 'studyFirstSubmitDate': '2026-02-10', 'studyFirstSubmitQcDate': '2026-02-10', 'lastUpdatePostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PPV Supine', 'timeFrame': 'Once a minute for 5 minutes', 'description': 'Pulse Pressure Variability (PPV) recorded from the arterial line while supine.'}, {'measure': 'PVI Supine', 'timeFrame': 'Once a minute for 5 minutes', 'description': 'Plethysmography Variability Index (PVI) recorded from the pulse oximeter while supine.'}, {'measure': 'PPV Prone', 'timeFrame': 'Once a minute for 5 minutes', 'description': 'Pulse Pressure Variability (PPV) recorded from the arterial line while prone.'}, {'measure': 'PVI Prone', 'timeFrame': 'Once a minute for 5 minutes', 'description': 'Plethysmography Variability Index (PVI) recorded from the pulse oximeter while prone.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Surgeries Undergoing General Anesthesia']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients undergoing surgery at Nationwide Children's Hospital only.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Consenting ASA 1-4 patients\n* Undergoing a surgical procedure with general anesthesia that requires placement of an arterial cannula and prone positioning\n\nExclusion Criteria:\n\n* Patients in whom an arterial cannula is not indicated or cannot be placed\n* Patients undergoing a surgical procedure that does not require prone positioning'}, 'identificationModule': {'nctId': 'NCT07415603', 'briefTitle': 'PPV vs PVI in the Supine and Prone Position', 'organization': {'class': 'OTHER', 'fullName': "Nationwide Children's Hospital"}, 'officialTitle': 'Variability and Correlation of the Pulse Pressure Variability (PPV) and the Plethysmography Variability Index (PVI) in the Supine and Prone Position', 'orgStudyIdInfo': {'id': 'STUDY00005745'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Prone surgical patients', 'interventionNames': ['Other: Observation']}], 'interventions': [{'name': 'Observation', 'type': 'OTHER', 'description': 'No intervention', 'armGroupLabels': ['Prone surgical patients']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Julie Rice-Weimer, BSN', 'role': 'CONTACT', 'email': 'julie.rice-weimer@nationwidechildrens.org', 'phone': '614-355-3142'}, {'name': 'Catherine Roth, MPH', 'role': 'CONTACT', 'email': 'catherine.roth@nationwidechildrens.org'}], 'overallOfficials': [{'name': 'Joseph Tobias, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Nationwide Children's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Joseph D. Tobias', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chief - Department of Anesthesiology & Pain Medicine', 'investigatorFullName': 'Joseph D. Tobias', 'investigatorAffiliation': "Nationwide Children's Hospital"}}}}