Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-04-06 @ 5:57 AM
Study NCT ID:
NCT07352033
Status:
COMPLETED
Last Update Posted:
2026-01-20
First Post:
2026-01-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Is Pulse Co-Oximetry a Reliable Alternative to Invasive Hemoglobin Measurement in Pediatric Neurosurgical Procedures?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-01-11', 'studyFirstSubmitDate': '2026-01-11', 'studyFirstSubmitQcDate': '2026-01-11', 'lastUpdatePostDateStruct': {'date': '2026-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Agreement and Correlation between Non-invasive Hemoglobin (SpHb) and Invasive Arterial Hemoglobin (Hb) levels.', 'timeFrame': 'Intraoperative period (from induction of anesthesia to extubation, approximately 2-5 hours'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Anemia (Diagnosis)']}, 'descriptionModule': {'briefSummary': 'The study evaluated the diagnostic accuracy and clinical utility of continuous SpHb across a comprehensive pediatric age spectrum-ranging from neonates to adolescents-undergoing high-risk neurosurgical procedures (cranial and spinal) characterized by significant potential for blood loss.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '2 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pediatric patients admitted to the Department of Neurosurgery for elective surgery requiring general anesthesia and invasive arterial blood pressure monitoring.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I-IV,\n* Scheduled for elective complex spinal surgery or cranial procedures under general anesthesia\n\nExclusion Criteria:\n\n* congenital heart disease\n* requirement for emergency surgery\n* pre-existing peripheral circulatory disorders'}, 'identificationModule': {'nctId': 'NCT07352033', 'briefTitle': 'Is Pulse Co-Oximetry a Reliable Alternative to Invasive Hemoglobin Measurement in Pediatric Neurosurgical Procedures?', 'organization': {'class': 'OTHER', 'fullName': 'Selcuk University'}, 'officialTitle': 'Is Pulse Co-Oximetry a Reliable Alternative to Invasive Hemoglobin Measurement in Pediatric Neurosurgical Procedures?', 'orgStudyIdInfo': {'id': 'F6'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pediatric Neurosurgery Patients', 'description': 'Pediatric patients undergoing neurosurgical procedures requiring invasive arterial pressure monitoring and hemoglobin measurement', 'interventionNames': ['Device: Masimo Radical-7® Pulse CO-Oximeter']}], 'interventions': [{'name': 'Masimo Radical-7® Pulse CO-Oximeter', 'type': 'DEVICE', 'description': 'Continuous non-invasive measurement of total hemoglobin (SpHb) using a pulse co-oximetry sensor during the surgery.', 'armGroupLabels': ['Pediatric Neurosurgery Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42130', 'city': 'Konya', 'state': 'Selçuklu', 'country': 'Turkey (Türkiye)', 'facility': 'Selcuk University', 'geoPoint': {'lat': 37.87135, 'lon': 32.48464}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Selcuk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'FUNDA ARUN', 'investigatorAffiliation': 'Selcuk University'}}}}