Ignite Creation Date:
2025-12-24 @ 12:12 PM
Ignite Modification Date:
2025-12-30 @ 1:09 PM
Study NCT ID:
NCT02269761
Status:
TERMINATED
Last Update Posted:
2023-03-22
First Post:
2014-10-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chest Ultrasound of ER Patients With Cough or SOB
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003371', 'term': 'Cough'}, {'id': 'D004417', 'term': 'Dyspnea'}, {'id': 'D012135', 'term': 'Respiratory Sounds'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014159', 'term': 'Transducers'}], 'ancestors': [{'id': 'D055615', 'term': 'Electrical Equipment and Supplies'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'whyStopped': "The patients were too sick to consent and we couldn't recruit enough to continue the study", 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2016-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-17', 'studyFirstSubmitDate': '2014-10-03', 'studyFirstSubmitQcDate': '2014-10-17', 'lastUpdatePostDateStruct': {'date': '2023-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'B-lines on chest ultrasound as a predictor of pulmonary edema and/or pneumonia', 'timeFrame': 'Up to 1 week', 'description': 'Results from the study ultrasound will be correlated with other imaging results and the emergency physicians initial impression.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Emergency Departments', 'Chest', 'Lung', 'Cough', 'Dyspnea', 'Wheezing', 'Ultrasound', 'Ultrasonography'], 'conditions': ['Cough', 'Dyspnea', 'Wheezing']}, 'descriptionModule': {'briefSummary': 'Acute dyspnea (shortness of breath) is a common complaint for patients presenting to the Emergency Department (ED). The chest radiograph (CXR) has been the mainstay in evaluating patients with shortness of breath and often provides the timely diagnosis of pneumonia, pneumothorax, pulmonary edema, among other primary diseases of the lung. There are limitations with chest radiograph such as large body mass (e.g, obesity) and patient positioning. On occasion, chest radiography findings are difficult to interpret. Lung ultrasonography may offer a means of clarifying ambiguous results.\n\nThe objective of this study to determine the usefulness of point of care lung ultrasound in evaluating patients presenting to the ED with shortness of breath, cough and/or wheezing.', 'detailedDescription': 'Acute dyspnea (shortness of breath) is a common complaint for patients presenting to the Emergency Department (ED). The chest radiograph (CXR) has been the mainstay in evaluating patients with shortness of breath and often provides the timely diagnosis of pneumonia, pneumothorax, pulmonary edema, among other primary diseases of the lung. There are limitations with chest radiograph such as large body mass (e.g, obesity) and patient positioning. On occasion, chest radiography findings are difficult to interpret. Lung ultrasonography may offer a means of clarifying ambiguous results. Advantages of ultrasound include real-time immediate evaluation, it is non-invasive and does not use radiation.\n\nThe investigators seek to perform a prospective evaluation of patients presenting to the University of Washington Medical Center ED for cough, wheezing and/or shortness of breath.\n\nThe objective of this study to determine the usefulness of point of care lung ultrasound in evaluating patients presenting to the ED with shortness of breath, cough and/or wheezing.\n\nThe specific aim of this study is to further define the utility of point-of-care ultrasound in the evaluation of emergency department patients presenting with cough, wheezing and/or shortness of breath. The investigators will compare ultrasound results to radiograph and tomography results when available, and to the physicians initial impression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Emergency Department (ED) patients with shortness of breath (SOB)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presenting to the Emergency Department with cough, wheezing and/or dyspnea (shortness of breath)\n* Referred for CXR and/or CT scan\n\nExclusion Criteria:\n\n* Life threatening medical condition requiring immediate treatment\n* Unable to sit up for a chest ultrasound\n* Unable to consent\n* Pregnant\n* Unable to speak, read and write in English'}, 'identificationModule': {'nctId': 'NCT02269761', 'briefTitle': 'Chest Ultrasound of ER Patients With Cough or SOB', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Prospective Evaluation With Ultrasound of Emergency Department Patients Presenting With Cough or Dyspnea', 'orgStudyIdInfo': {'id': '47935'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Nuvis Diagnostic Ultrasound System', 'type': 'DEVICE', 'otherNames': ['Diagnostic ultrasound system and transducers', 'C5-2 curve linear array USB transducer'], 'description': 'Ultrasound of the chest'}]}, 'contactsLocationsModule': {'locations': [{'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Theodore J Dubinsky, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'Philips Healthcare', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Radiology', 'investigatorFullName': 'Theodore Dubinsky', 'investigatorAffiliation': 'University of Washington'}}}}