Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2026-03-05 @ 11:18 PM
Study NCT ID:
NCT04483193
Status:
UNKNOWN
Last Update Posted:
2020-08-19
First Post:
2020-07-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reliability of Duplex Ultrasound for Diagnosis of Deep Vein Thrombosis Performed by Nurses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D018616', 'term': 'Ultrasonography, Doppler, Duplex'}], 'ancestors': [{'id': 'D018608', 'term': 'Ultrasonography, Doppler'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-07-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2021-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-18', 'studyFirstSubmitDate': '2020-07-20', 'studyFirstSubmitQcDate': '2020-07-22', 'lastUpdatePostDateStruct': {'date': '2020-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Validity of duplex ultrasound', 'timeFrame': 'Comparison of two examinations performed with a maximum interval of 24 hours.', 'description': 'Validity of duplex ultrasound examination performed by a trained general intensive care nurses when compared with the examination performed by a trained physician - intensivist, specialist in Point-of-Care ultrasound.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ultrasound']}, 'referencesModule': {'references': [{'pmid': '32216998', 'type': 'BACKGROUND', 'citation': 'Skulec R, Kohlova A, Miksova L, Cerny V. The reliability of ultrasound compression test performed by general ICU nurses in the critically ill patients: A preliminary prospective clinical study. Eur J Intern Med. 2020 Jun;76:130-131. doi: 10.1016/j.ejim.2020.03.007. Epub 2020 Mar 23. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess validity of extended duplex ultrasound examination for diagnosis of proximal deep vein thrombosis performed by general intensive care unit nurses in the critically ill patients.', 'detailedDescription': "Critically ill patients hospitalized in the intensive care unit are in increased risk of proximal deep vein thrombosis despite thromboprophylactic measures. Diagnostic method of the first choice is Point-of-Care ultrasound examination. This method is usually performed by a trained intensive care physician. However, if this examination could be performed by trained nurses, its availability would be greatly increased. The results of the investigator's pilot study showed that general nurses are able to diagnose proximal deep vein thrombosis in critically ill patients by compression ultrasound test with a sensitivity of 88,9 % and a specificity of 99 %. Before implementation of this examination into the optional competencies of general nurses, the results need to be confirmed in a larger group of patients. This is the goal of proposed clinical study.\n\nIn this prospective observational study, the patients will be investigated by extended duplex ultrasound (compression ultrasound test combined with colour doppler imaging in the range from the groin to the popliteal region) by a trained nurse and on the same day, the examination will be repeated by a trained physician - intensivist. The results of the examinations of each patient will be blinded until both tests will be performed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult critically ill patients.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inpatients\n* Critically ill patients hospitalised in the intensive care unit for more than 72 hours\n\nExclusion Criteria:\n\n* Known deep vein thrombosis\n* Contraindication of ultrasound examination\n* Refusal of ultrasound examination by patient'}, 'identificationModule': {'nctId': 'NCT04483193', 'briefTitle': 'Reliability of Duplex Ultrasound for Diagnosis of Deep Vein Thrombosis Performed by Nurses', 'organization': {'class': 'OTHER', 'fullName': 'Emergency Medical Service of the Central Bohemian Region, Czech Republic'}, 'officialTitle': 'Reliability of Extended Duplex Ultrasound for Diagnosis of Proximal Deep Vein Thrombosis Performed by General Intensive Care Unit Nurses in the Critically Ill Patients', 'orgStudyIdInfo': {'id': '284/36'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Critically ill patients', 'description': 'Critically ill patients hospitalised at the intensive care unit.', 'interventionNames': ['Diagnostic Test: Duplex ultrasound']}], 'interventions': [{'name': 'Duplex ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'Point-of-Care compression ultrasound test combined with colour doppler imaging in the range from the groin to the popliteal region of both lower extremities.', 'armGroupLabels': ['Critically ill patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40113', 'city': 'Ústí nad Labem', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Roman Skulec, MD, PhD', 'role': 'CONTACT', 'email': 'skulec@email.cz', 'phone': '00420777577497'}], 'facility': 'Masaryk Hospital Usti nad Labem', 'geoPoint': {'lat': 50.6607, 'lon': 14.03227}}], 'centralContacts': [{'name': 'Roman Skulec, MD, PhD', 'role': 'CONTACT', 'email': 'skulec@email.cz', 'phone': '00420777577497'}, {'name': 'Lenka Miksova', 'role': 'CONTACT', 'email': 'lenusmiksova@seznam.cz', 'phone': '00420774140032'}], 'overallOfficials': [{'name': 'Roman Skulec, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Masaryk Hospital Usti nad Labem'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emergency Medical Service of the Central Bohemian Region, Czech Republic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Masaryk Hospital Usti nad Labem', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Roman Skulec', 'investigatorAffiliation': 'Masaryk Hospital Usti nad Labem'}}}}