Ultrasound in Undifferentiated Hypotension (US-UHP)
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|ClinicalTrials.gov Identifier: NCT01572571|
Recruitment Status : Completed
First Posted : April 6, 2012
Last Update Posted : December 19, 2013
- Symptomatic undifferentiated hypotension represents a negative prognostic factor and the strongest predictor of in-hospital mortality.
- Misdiagnosis may lead to delayed or incorrect treatment of some life-threatening conditions.
- The aim of the study is to evaluate the feasibility and accuracy of a new bedside ultrasound method that consists in the focused imaging of the thorax, abdomen and leg veins, in emergency.
- Hypotensive (<100 mm/Hg) patients presenting to our emergency department, complaining of at least one of the neurologic, respiratory and cutaneous signs and symptoms of inadequate tissue perfusion, are prospectively studied by ultrasound-focused assessment of the heart, lungs, inferior vena cava, peritoneum, aorta and leg deep veins.
- On the basis of physical examination and ultrasound results, the operator declares the diagnostic hypothesis without influencing the attending physician and the following diagnostic procedure (which includes ultrasound, when needed).
- The diagnostic hypothesis is compared with the final diagnosis, obtained after the hospital route and discussed by a panel of three blinded experts (one radiologist, one cardiologist and one emergency physician).
- The statistical agreement is calculated by the k of Cohen with p-value, confidence intervals and raw agreement (Ra).
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||100 participants|
|Official Title:||Focused Multiorgan Ultrasound in the Emergency Evaluation of Undifferentiated Hypotension|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
- Correlation between the ultrasound primary diagnosis and the clinical final diagnosis [ Time Frame: Clinical judgment on the final diagnosis as deduced from all the data obtained after hospital stay ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01572571
|San Luigi Gonzaga University Hospital, Department of Emergency Medicine|
|Orbassano, Torino, Italy, 10043|
|Principal Investigator:||Giovanni Volpicelli, MD||San Luigi Gonzaga Hospital|