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Ultrasound in Undifferentiated Hypotension

NCT01572571 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2013-12-19

No results posted yet for this study

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

Sponsors & Collaborators

  • San Luigi Gonzaga Hospital

    lead OTHER

Principal Investigators

  • Giovanni Volpicelli, MD · San Luigi Gonzaga Hospital

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01572571 on ClinicalTrials.gov