CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 100 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT01572571
NCT01572571N/ACompleted

Focused Multiorgan Ultrasound in the Emergency Evaluation of Undifferentiated Hypotension

San Luigi Gonzaga Hospital·observational·Posted Apr 6, 2012·Updated Dec 19, 2013

In Brief

An observational study for Hypotension. Completed, enrolled 100 participants across 1 site.

Detailed 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).

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsHypotension
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 6, 2012
Enrollment StartDec 1, 2011
Primary CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 14.2 years ago