Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2026-02-22 @ 7:02 AM
Study NCT ID:
NCT01847859
Status:
COMPLETED
Last Update Posted:
2021-11-09
First Post:
2013-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pocket-size Ultrasound by Nurses in Cardiothoracic Post-operative Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019220', 'term': 'High-Energy Shock Waves'}], 'ancestors': [{'id': 'D000069453', 'term': 'Ultrasonic Waves'}, {'id': 'D013016', 'term': 'Sound'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-05', 'studyFirstSubmitDate': '2013-05-02', 'studyFirstSubmitQcDate': '2013-05-06', 'lastUpdatePostDateStruct': {'date': '2021-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Clinical impact', 'timeFrame': '0 days and 30 days', 'description': 'Clinical influence of detection/assessment of pleural and pericardial effusion by ultrasound.'}], 'primaryOutcomes': [{'measure': 'Feasibility and reliability', 'timeFrame': '0 days', 'description': 'Feasibility: Proportion of patients where the pleural and pericardial cavitis can be assessed and interpreted by ultrasound performed by nurses compared with cardiologists.'}, {'measure': 'Reliability', 'timeFrame': '0 days', 'description': 'Validation of ultrasound examinations and interpretation of the pleural and pericardial cavities by nurses compared with cardiologists as reference.'}], 'secondaryOutcomes': [{'measure': 'Time use', 'timeFrame': '0 days', 'description': 'Comparison of the time use of ultrasound examinations of the pleural and pericardial cavities when examinations are performed by nurses and cardiologists, respectively.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cardiothoracic surgery', 'Post-operative', 'Nurses', 'Cardiac', 'Echocardiography', 'Pocket-size', 'Hand-held'], 'conditions': ['Cardiothoracic Surgery']}, 'referencesModule': {'references': [{'pmid': '25611808', 'type': 'DERIVED', 'citation': 'Graven T, Wahba A, Hammer AM, Sagen O, Olsen O, Skjetne K, Kleinau JO, Dalen H. Focused ultrasound of the pleural cavities and the pericardium by nurses after cardiac surgery. Scand Cardiovasc J. 2015 Feb;49(1):56-63. doi: 10.3109/14017431.2015.1009383. Epub 2015 Feb 6.'}]}, 'descriptionModule': {'briefSummary': 'The investigators aim to study the feasibility and reliability of pocket-size diagnostic ultrasound examinations performed by nurses of postoperative patients who have underwent cardiothoracic surgery in a cardiac unit.', 'detailedDescription': 'Patient inclusion: Post-operative cardiothoracic surgery patients transferred to a cardiac unit. All such patients are eligible for inclusion if they consent to participate in the study. No other exclusion criteria other than not willing/able to give their consent. Only postoperative patients will be included.\n\nStudy population: Approximately 50 patients\n\nIntervention: All participants will undergo careful medical history, physical examination and blood tests led by residents. All patients will routinely be examined with ultrasound by nurses trained in ultrasound examinations of the pleural space and the pericardium and a complete high-end echocardiography including assessment of both pleural cavities and the pericardial space will be performed in all by cardiologists.\n\nStatistics and results: Feasibility and reliability will be studied.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Post-operative cardiothoracic patients admitted to the cardiac unit at the local hospital\n\nExclusion Criteria:\n\n* Not able or not willing to consent'}, 'identificationModule': {'nctId': 'NCT01847859', 'briefTitle': 'Pocket-size Ultrasound by Nurses in Cardiothoracic Post-operative Patients', 'organization': {'class': 'OTHER', 'fullName': 'Helse Nord-Trøndelag HF'}, 'officialTitle': 'Feasibility and Reliability of Routine Ultrasound Examination Performed by Nurses in Cardiothoracic Post-operative Patients', 'orgStudyIdInfo': {'id': 'LH-2013-2'}, 'secondaryIdInfos': [{'id': 'Spl postop hjerte', 'type': 'OTHER', 'domain': 'Levanger Hospital'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ultrasound performed by nurses', 'description': 'Focused examination of the pleural and pericardial cavity. Cardiologists perform reference ultrasound examinations.', 'interventionNames': ['Procedure: Ultrasound examination by nurses']}], 'interventions': [{'name': 'Ultrasound examination by nurses', 'type': 'PROCEDURE', 'otherNames': ['Ultrasound'], 'description': 'Focused examination of the pleural space and inferior vena cava.Reference method: Cardiologists performed ultrasound examinations.', 'armGroupLabels': ['Ultrasound performed by nurses']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7601', 'city': 'Levanger', 'country': 'Norway', 'facility': 'Department of medicine, Levanger Hospital, Nord-Trøndelag Health Trust', 'geoPoint': {'lat': 63.74644, 'lon': 11.29963}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helse Nord-Trøndelag HF', 'class': 'OTHER'}, 'collaborators': [{'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}