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