Ignite Creation Date:
2025-12-25 @ 2:35 AM
Ignite Modification Date:
2025-12-30 @ 8:34 AM
Study NCT ID:
NCT05287334
Status:
UNKNOWN
Last Update Posted:
2022-08-09
First Post:
2022-03-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Blood Loss Measurement Using Electrical Impedance Tomography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single group assignment. Approx 10-15 voluntary blood donors.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-08', 'studyFirstSubmitDate': '2022-03-10', 'studyFirstSubmitQcDate': '2022-03-17', 'lastUpdatePostDateStruct': {'date': '2022-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in chest electrical impedance due to blood loss.', 'timeFrame': 'Time frame of one voluntary blood donation process (15 min)', 'description': 'A change in the electrical impedance of the chest of a voluntary blood donor caused by a blood donation.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Blood donation, EIT'], 'conditions': ['Blood Loss']}, 'descriptionModule': {'briefSummary': 'The project focuses on the possibility of detecting blood loss using electrical impedance tomography. Based on previous animal experiments, it was found that the bolus of saline significantly affects the signal of chest bioimpedance. It is assumed that blood loss of a similar volume will cause a similar signal change with the opposite trend. The aim of this project is to determine whether there is a significant change in the thoracic electrical impedance tomography signal when blood loss is caused by voluntary blood donation.', 'detailedDescription': 'Electrical impedance tomography is a bedside method of ventilation monitoring. The bioimpedance of the tissue depends, among other things, on its blood content. The area of the chest and especially the lungs is a heavily perfused tissue, which also serves as one of the reservoirs of blood in case of blood loss. It is therefore possible that blood loss will be visible on chest bioimpedance relatively soon.\n\nThe study will be performed on voluntary blood donors. Blood loss of 450 mL will be caused by the collection of donated blood. During blood collection at the transfusion department, thoracic bioimpedance will be measured using electrical impedance tomography. The resulting signal change will then be analyzed to determine the possibility of detecting and measuring blood loss using electrical impedance tomography.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* voluntary blood donation\n\nExclusion Criteria:\n\n* standard exclusion criteria for voluntary blood donation based on the transfusion station protocol\n* standard exclusion criteria for electrical impedance tomography according to the manufacturer'}, 'identificationModule': {'nctId': 'NCT05287334', 'briefTitle': 'Blood Loss Measurement Using Electrical Impedance Tomography', 'organization': {'class': 'OTHER', 'fullName': 'Czech Technical University in Prague'}, 'officialTitle': 'Measurement of Blood Loss Using Electrical Impedance Tomography', 'orgStudyIdInfo': {'id': '12229'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Voluntary blood donors', 'description': 'Voluntary blood donors undergoing standard blood donation while measuring electrical impedance of the chest .', 'interventionNames': ['Device: Electrical impedance tomography measurement']}], 'interventions': [{'name': 'Electrical impedance tomography measurement', 'type': 'DEVICE', 'description': "During standard blood donation, donors' chest bioimpedance will be measured using electrical impedance tomography.", 'armGroupLabels': ['Voluntary blood donors']}]}, 'contactsLocationsModule': {'locations': [{'zip': '272 01', 'city': 'Kladno', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Karel Roubik, PhD', 'role': 'CONTACT', 'email': 'roubik@fbmi.cvut.cz', 'phone': '+420 603 479 901'}], 'facility': 'Czech Technical University, Faculty of Biomedical Engineering', 'geoPoint': {'lat': 50.14734, 'lon': 14.10285}}, {'zip': '27201', 'city': 'Kladno', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Vaclav Ort, M.Eng', 'role': 'CONTACT', 'email': 'ortvacla@fbmi.cvut.cz', 'phone': '+420731577649'}], 'facility': 'Czech technical university in Prague, Facutly of biomedical engineering', 'geoPoint': {'lat': 50.14734, 'lon': 14.10285}}], 'centralContacts': [{'name': 'Vaclav Ort, M.Eng.', 'role': 'CONTACT', 'email': 'ortvacla@fbmi.cvut.cz', 'phone': '+420 731 577 649'}], 'overallOfficials': [{'name': 'Vaclav Ort, M.Eng.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Czech Technical University in Prague, Fac. of Biomedical Engineering'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Czech Technical University in Prague', 'class': 'OTHER'}, 'collaborators': [{'name': 'Military University Hospital, Prague', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}