Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-26 @ 4:24 AM
Study NCT ID:
NCT03957460
Status:
COMPLETED
Last Update Posted:
2021-05-11
First Post:
2019-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Accuracy of Continuous and Non-invasive Hemoglobin Monitoring
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2017-12-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-09', 'studyFirstSubmitDate': '2019-05-17', 'studyFirstSubmitQcDate': '2019-05-19', 'lastUpdatePostDateStruct': {'date': '2021-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'difference between SpHb value in g/dL and SaHb value in g/dL (SpHb - SaHb)', 'timeFrame': 'from the start of anesthesia to the end of anesthesia, an average 2 hours', 'description': 'SpHb value in g/dL is measured by co-oxymetry, and SaHb value in g/dL is measured by blood sampling.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'The primary purpose of this observational study is to investigate the accuracy on the continuous and non-invasive hemoglobin monitoring during laparoscopic gastrectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The patients were scheduled for laparoscopic gastrectomy and recieved the SpHb monitoring during surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* laparoscopic gastrectomy under general anesthesia\n\nExclusion Criteria:\n\n* atypical hemoglobin disease, infective state, cardiovascular disease, peripheral vascular disease'}, 'identificationModule': {'nctId': 'NCT03957460', 'briefTitle': 'Accuracy of Continuous and Non-invasive Hemoglobin Monitoring', 'organization': {'class': 'OTHER', 'fullName': 'Ajou University School of Medicine'}, 'officialTitle': 'Accuracy of Continuous and Non-invasive Hemoglobin Monitoring During Laparoscopic Gastrectomy: Observational Study', 'orgStudyIdInfo': {'id': 'AJIRB-MED-OBS-17-216'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'continuous and noninvasive hemoglobin monitoring', 'description': 'Group receive the continuous and noninvasive hemoglobin monitoring during laparoscopic gastrectomy.', 'interventionNames': ['Other: SpHb monitoring']}], 'interventions': [{'name': 'SpHb monitoring', 'type': 'OTHER', 'description': 'Subjects receive the continuous and noninvasive hemoglobin monitoring (SpHb monitoring).', 'armGroupLabels': ['continuous and noninvasive hemoglobin monitoring']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Suwon', 'country': 'South Korea', 'facility': 'Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ajou University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Ji Eun Kim', 'investigatorAffiliation': 'Ajou University School of Medicine'}}}}