Ultrasound in Undifferentiated Hypotension (US-UHP)
|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|
|Primary Completion Date :||December 2013|
|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 ]
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|