Clinical Trial: Ultrasound in Undifferentiated Hypotension
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Focused Multiorgan Ultrasound in the Emergency Evaluation of Undifferentiated Hypotension
Brief 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).
Detailed Summary:
Sponsor: San Luigi Gonzaga Hospital
Current Primary Outcome: 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 ]
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: San Luigi Gonzaga Hospital
Dates:
Date Received: April 4, 2012
Date Started: December 2011
Date Completion:
Last Updated: December 18, 2013
Last Verified: December 2013