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Trials / Completed

CompletedNCT01572571

Ultrasound in Undifferentiated Hypotension

Focused Multiorgan Ultrasound in the Emergency Evaluation of Undifferentiated Hypotension

Status
Completed
Phase
Study type
Observational
Enrollment
100 (actual)
Sponsor
San Luigi Gonzaga Hospital · Academic / Other
Sex
All
Age
16 Years
Healthy volunteers
Not accepted

Summary

Background * 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. Aim \- 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. Methods * 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).

Conditions

Timeline

Start date
2011-12-01
Primary completion
2013-12-01
Completion
2013-12-01
First posted
2012-04-06
Last updated
2013-12-19

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT01572571. Inclusion in this directory is not an endorsement.