NCT02638649|Completed
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Sponsor study identifier
observational
69
1 country
2
Study Start
September 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 15, 2018
Actual (reported)Study Completion
September 15, 2018
Actual (reported)This is a pilot observational feasibility study of the ability of paramedics to assess thoracic ultrasound findings in the prehospital environment. The primary goal of the study is to determine whether paramedics are able to accurately assess for sonographic B-lines in patients with undifferentiated shortness of breath at least 80% of the time in the prehospital environment using a portable ultrasound (U/S) device.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 15, 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 11, 2015
Actual (reported)December 23, 2015
Actual (reported)September 2016
Date type not reportedThis date has not been verified as actual or estimated.
September 15, 2018
Actual (reported)September 15, 2018
Actual (reported)Accuracy of Paramedics' assessments of ultrasound for unilateral or bilateral B-lines
The paramedic will use the portable U/S machine to look for the presence of either unilateral/bilateral B-lines indicating possible pneumonia (unilateral B-lines) or pulmonary edema (bilateral B-lines). The paramedic will document the presence or absence of B-lines for each lung on the prehospital study sheet. The attending ED physician will be notified of the enrolled patient and, blinded to the paramedic's interpretation, will then conduct the same U/S study and document their findings and the final diagnosis of the patient using the patient's name, birthdate and MRN (Medical Record Number) on the ED study sheet. An U/S expert, blinded to the patient's diagnosis, the U/S operator, and confirmatory imaging, will review the recorded images obtained in the prehospital setting. The expert's interpretation of the images will be confirmed by a second expert for at least 15 % of the cases. The goal is 80% accuracy. The accuracy will be evaluated up to 12 months after the U/S is taken.
up to 12 months
Accuracy of Paramedics' assessments of ultrasound for interpretation of lung sliding, pleural effusions, and pericardial effusions.
up to 12 months
All subjects who call 9-1-1 for difficulty breathing will have the potential to be enrolled in the study.
At each call, the paramedic will initially evaluate the patient clinically conducting a standard history and physical exam. The paramedic will then use the portable U/S machine to look for the presence of either unilateral or bilateral B-lines indicating possible pneumonia (in the case of unilateral B-lines) or pulmonary edema (in the case of bilateral B-lines). The paramedic will then document the presence or absence of B-lines for each lung on the prehospital study sheet. The paramedic will then use the U/S to evaluate for the presence of pleural effusions, lung sliding and pericardial effusion.
Patients presenting with dyspnea
Yale-New Haven Hospital-Saint Raphael Campus
New Haven, Connecticut, 06517, United States
Yale New Haven Hospital
New Haven, Connecticut, 06519-1362, United States
David C Cone, MD
Yale University
69 participants (actual enrollment reported by the registry).
First Submitted
December 11, 2015
First Posted
December 23, 2015
Study Start
September 2016
Date type not reportedThis date has not been verified as actual or estimated.
The ULTRA Study: Cross-Comparison of Ultrasound Systems
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
September 15, 2018
Actual (reported)Study Completion
September 15, 2018
Actual (reported)Last Updated
March 23, 2020
Record last verified: 2020-03
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Source: ClinicalTrials.gov.
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