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.