Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2026-01-17 @ 7:36 PM
Study NCT ID:
NCT01794468
Status:
COMPLETED
Last Update Posted:
2013-02-18
First Post:
2013-02-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A New Monitor to Measure Dermal Blood Flow in Critically Ill Patients: a Preliminary Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018467', 'term': 'Positive-Pressure Respiration, Intrinsic'}, {'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2005-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-15', 'studyFirstSubmitDate': '2013-02-15', 'studyFirstSubmitQcDate': '2013-02-15', 'lastUpdatePostDateStruct': {'date': '2013-02-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dermal blood flow measurements', 'timeFrame': 'over an 8-hour period', 'description': 'DBF monitor - non-invasive method for detecting changes in perfusion in critically ill patients.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dermal blood flow', 'critically ill'], 'conditions': ['Positive-Pressure Respiration, Intrinsic', 'Critically Ill Patients']}, 'descriptionModule': {'briefSummary': 'Background: Conditions of reduced perfusion are characterized by redistribution of blood flow away from the skin to more vital organs.\n\nStudy Objectives: To assess the efficacy of a non-invasive, dermal blood flow (DBF) monitor in detecting changes in perfusion in critically ill patients.\n\nPreliminary Study\n\nStudy Population: critically ill patients in a general ICU', 'detailedDescription': 'DBF, finger plethysmography and invasive mean arterial pressure (MAP) were recorded over an 8-hour period. DBF was measured using the I.S. MedTech DBF monitor, based on the hot-wire principle of thermal balance of a heater cooled by a moving medium, via a skin probe placed on the anterior chest wall. Sensitivity was evaluated by visual inspection during active states, either induced, e.g. fluid administration, or spontaneous, e.g. altered hemodynamics. Specificity was evaluated during stable states (minimal fluctuations of MAP and no active interventions applied or required). Data are expressed in terms of standard deviation (SD) and of the difference (SDD) between the MAP and each of the tested methods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients were ventilated and sedated during an 8-hour period of measurement\n\nExclusion Criteria:\n\n* Age \\< 18 years old'}, 'identificationModule': {'nctId': 'NCT01794468', 'acronym': 'MDBF-CIP', 'briefTitle': 'A New Monitor to Measure Dermal Blood Flow in Critically Ill Patients: a Preliminary Study', 'organization': {'class': 'OTHER', 'fullName': 'Rabin Medical Center'}, 'officialTitle': 'A New Monitor to Measure Dermal Blood Flow in Critically Ill Patients: a Preliminary Study', 'orgStudyIdInfo': {'id': '3030'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'study group-Dermal blood flow measurements', 'description': 'Dermal blood flow was measured with the Dermal Blood Flow (DBF) monitor', 'interventionNames': ['Other: Dermal blood flow measurements']}], 'interventions': [{'name': 'Dermal blood flow measurements', 'type': 'OTHER', 'description': 'Dermal blood flow was measured with the Dermal Blood Flow (DBF) monitor (I.S. MedTech, Israel), which consists of a skin probe and a measuring and control feedback unit.', 'armGroupLabels': ['study group-Dermal blood flow measurements']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49100', 'city': 'Petah Tikva', 'country': 'Israel', 'facility': "ICU dep't , Rabin MC", 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}], 'overallOfficials': [{'name': 'Jonathan Cohen, Professor,MD', 'role': 'STUDY_CHAIR', 'affiliation': "ICU dep't, Rabin MC,Petah Tikva, Israel"}, {'name': 'Pierre Singer, Professor,MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "ICU dep't, Rabin MC,Petah Tikva, Israel"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rabin Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor , MD', 'investigatorFullName': 'Pierre singer', 'investigatorAffiliation': 'Rabin Medical Center'}}}}