Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2026-01-05 @ 5:34 PM
Study NCT ID:
NCT07135492
Status:
COMPLETED
Last Update Posted:
2025-08-22
First Post:
2025-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intraoperative Continuous Noninvasive Hemoglobin Monitoring in Patients Undergoing Thoracic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-07-13', 'size': 345774, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-08-13T14:13', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-07-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-13', 'studyFirstSubmitDate': '2025-07-04', 'studyFirstSubmitQcDate': '2025-08-13', 'lastUpdatePostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the correlation between continuous hemoglobin and inasive hemoglubin at the preoperative period', 'timeFrame': '6 Hours', 'description': 'continuous hemoglobin % monitoring, Rainbow adult ReSposable™ sensors (rev E) were attached to the ring or middle fingertip of each subject and connected to a Radical-7 Pulse CO-Oximeter (SET version 7601; Masimo Corporation, Irvine, CA).\n\ninvasive hemoglubin % monitoring, Blood samples were collected and analyzed using a satellite blood analyzer (Gem Premier 4000)'}, {'measure': 'the correlation between continuous hemoglobin and inasive hemoglubin 1 hour after start of surgery', 'timeFrame': '6 Hours', 'description': 'continuous hemoglobin % monitoring, Rainbow adult ReSposable™ sensors (rev E) were attached to the ring or middle fingertip of each subject and connected to a Radical-7 Pulse CO-Oximeter (SET version 7601; Masimo Corporation, Irvine, CA).\n\ninvasive hemoglubin % monitoring, Blood samples were collected and analyzed using a satellite blood analyzer (Gem Premier 4000)'}, {'measure': 'the correlation between continuous hemoglobin and inasive hemoglubin 2 hours after start of surgery', 'timeFrame': '6 Hours', 'description': 'continuous hemoglobin % monitoring, Rainbow adult ReSposable™ sensors (rev E) were attached to the ring or middle fingertip of each subject and connected to a Radical-7 Pulse CO-Oximeter (SET version 7601; Masimo Corporation, Irvine, CA).\n\ninvasive hemoglubin % monitoring, Blood samples were collected and analyzed using a satellite blood analyzer (Gem Premier 4000)'}, {'measure': 'the correlation between continuous hemoglobin and inasive hemoglubin 3 hours after start of surgery', 'timeFrame': '6 Hours', 'description': 'continuous hemoglobin % monitoring, Rainbow adult ReSposable™ sensors (rev E) were attached to the ring or middle fingertip of each subject and connected to a Radical-7 Pulse CO-Oximeter (SET version 7601; Masimo Corporation, Irvine, CA).\n\ninvasive hemoglubin % monitoring, Blood samples were collected and analyzed using a satellite blood analyzer (Gem Premier 4000)'}, {'measure': 'the correlation between continuous hemoglobin and inasive hemoglubin 4 hours after start of surgery', 'timeFrame': '6 Hours', 'description': 'continuous hemoglobin % monitoring, Rainbow adult ReSposable™ sensors (rev E) were attached to the ring or middle fingertip of each subject and connected to a Radical-7 Pulse CO-Oximeter (SET version 7601; Masimo Corporation, Irvine, CA).\n\ninvasive hemoglubin % monitoring, Blood samples were collected and analyzed using a satellite blood analyzer (Gem Premier 4000)'}, {'measure': 'the correlation between continuous hemoglobin and inasive hemoglubin at the end of surgery', 'timeFrame': '6 Hours', 'description': 'continuous hemoglobin % monitoring, Rainbow adult ReSposable™ sensors (rev E) were attached to the ring or middle fingertip of each subject and connected to a Radical-7 Pulse CO-Oximeter (SET version 7601; Masimo Corporation, Irvine, CA).\n\ninvasive hemoglubin % monitoring, Blood samples were collected and analyzed using a satellite blood analyzer (Gem Premier 4000)'}, {'measure': 'the correlation between continuous hemoglobin and inasive hemoglubin after recovery of the patient', 'timeFrame': '6 Hours', 'description': 'continuous hemoglobin % monitoring, Rainbow adult ReSposable™ sensors (rev E) were attached to the ring or middle fingertip of each subject and connected to a Radical-7 Pulse CO-Oximeter (SET version 7601; Masimo Corporation, Irvine, CA).\n\ninvasive hemoglubin % monitoring, Blood samples were collected and analyzed using a satellite blood analyzer (Gem Premier 4000)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Thoracic', 'surgery', 'hemoglobin', 'transcutaneous oximetry.'], 'conditions': ['Thoracic Anesthesia']}, 'referencesModule': {'references': [{'pmid': '26654895', 'type': 'BACKGROUND', 'citation': 'Joseph B, Haider A, Rhee P. Non-invasive hemoglobin monitoring. Int J Surg. 2016 Sep;33(Pt B):254-257. doi: 10.1016/j.ijsu.2015.11.048. Epub 2015 Nov 30.'}]}, 'descriptionModule': {'briefSummary': 'This study investigates the correlation between noninvasive hemoglobin monitoring (SpHb) and invasive hemoglobin measurement (InvHb) in guiding blood transfusions during thoracic surgeries.\n\nMethods: A non-interventional design was used to evaluate the relationship between SpHb and InvHb readings in the context of transfusion decisions. Data were obtained from 80 patients aged 18 years or older undergoing thoracic procedures. Continuous SpHb monitoring was performed, and concurrent InvHb samples were collected for comparison. The primary endpoint was the degree of correlation between SpHb and InvHb values.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients were monitored using ASA standard monitors, along with invasive arterial and/or central venous monitoring as part of their standard care.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged 18 years and older who were subjected to open thoracic surgery\n* the length of surgery was ≥ 4 hours\n\nExclusion Criteria:\n\n* dysrhythmia\n* coagulopathy'}, 'identificationModule': {'nctId': 'NCT07135492', 'acronym': 'noninvasive Hb', 'briefTitle': 'Intraoperative Continuous Noninvasive Hemoglobin Monitoring in Patients Undergoing Thoracic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Intraoperative Continuous Noninvasive Hemoglobin Monitoring in Patients Undergoing Thoracic Surgery', 'orgStudyIdInfo': {'id': 'A01890'}}, 'armsInterventionsModule': {'interventions': [{'name': 'continuous noninvasive hemoglobin monitoring', 'type': 'DIAGNOSTIC_TEST', 'description': 'noninvasive hemoglobin monitoring, Rainbow® Adult ReSposable™ sensors (Rev E) were placed on either the ring or middle fingertip of each participant and connected to a Radical-7 Pulse CO-Oximeter (SET version 7601; Masimo Corp., Irvine, CA).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '31511', 'city': 'Jeddah', 'state': 'Mekkah', 'country': 'Saudi Arabia', 'facility': 'Ministry of health', 'geoPoint': {'lat': 21.49012, 'lon': 39.18624}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor of Anesthesia', 'investigatorFullName': 'Mona Mohamed Mogahed', 'investigatorAffiliation': 'Tanta University'}}}}