Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-31 @ 2:21 PM
Study NCT ID:
NCT05690633
Status:
COMPLETED
Last Update Posted:
2025-03-04
First Post:
2023-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of Obtaining Pulse Oximetry Readings from the Oropharynx
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010092', 'term': 'Oximetry'}], 'ancestors': [{'id': 'D001784', 'term': 'Blood Gas Analysis'}, {'id': 'D001774', 'term': 'Blood Chemical Analysis'}, {'id': 'D019963', 'term': 'Clinical Chemistry Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-28', 'studyFirstSubmitDate': '2023-01-10', 'studyFirstSubmitQcDate': '2023-01-10', 'lastUpdatePostDateStruct': {'date': '2025-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of Pulse Oximetry', 'timeFrame': 'Baseline', 'description': 'Accuracy of pulse oximetry readings (SpO2) as compared with arterial oxygen saturations'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Surgery', 'Arterial Catheterization, Peripheral']}, 'descriptionModule': {'briefSummary': 'This is a prospective study to evaluate the feasibility of obtaining a pulse oximetry ready from the oropharynx with a standard oximeter probe that has been attached to an oral airway or a tongue blade. The study will compare the values from the peripheral pulse oximeter on a finger, toe, foot or hand with the that from the oropharyngeal oximeter. The study will also compare the saturation from an arterial blood gas (ABG) collected as standard of care with that obtained from the oropharyngeal oximeter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing a surgical procedure with general anesthesia and requiring an invasive arterial cannula\n\nExclusion Criteria:\n\n* Patients in whom an arterial cannula is not indicated for the surgical procedure\n* Patients in whom a peripheral pulse oximeter value cannot be obtained\n* Patients in whom an invasive arterial cannula cannot be placed\n* Patients with any type of intra-oral pathology or injury\n* Patients in whom access to the oropharynx is restricted or not feasible for any clinical reason'}, 'identificationModule': {'nctId': 'NCT05690633', 'briefTitle': 'Feasibility of Obtaining Pulse Oximetry Readings from the Oropharynx', 'organization': {'class': 'OTHER', 'fullName': "Nationwide Children's Hospital"}, 'officialTitle': 'Feasibility of Obtaining Pulse Oximetry Readings from the Oropharynx', 'orgStudyIdInfo': {'id': 'STUDY00003039'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oropharyngeal oximetry', 'description': 'The use of a pulse oximeter in the oropharynx on either an oral airway or a tongue blade.', 'interventionNames': ['Device: Pulse oximetry']}], 'interventions': [{'name': 'Pulse oximetry', 'type': 'DEVICE', 'description': 'Noninvasive method of measuring the saturation of oxygen in the blood.', 'armGroupLabels': ['Oropharyngeal oximetry']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Nationwide Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Joseph D. Tobias', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chief, Dept. of Anesthesiology & Pain Medicine', 'investigatorFullName': 'Joseph D. Tobias', 'investigatorAffiliation': "Nationwide Children's Hospital"}}}}