Ultrasound in Undifferentiated Hypotension

Focused Multiorgan Ultrasound in the Emergency Evaluation of Undifferentiated Hypotension

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01572571

Acronym

US-UHP

Enrollment

100

Registered

2012-04-06

Start date

2011-12-31

Completion date

2013-12-31

Last updated

2013-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypotension

Keywords

Emergency ultrasound, Focused ultrasound, Point-of-care ultrasound, 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).

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

Inclusion criteria

* Arterial pressure \<100 mm/Hg at presentation * At least one of the following symptoms: * Unresponsive * Syncope * Impaired mental status * Respiratory distress * Severe malaise and fatigue

Exclusion criteria

* Patients undergoing cardiopulmonary resuscitation * Trauma patients * Electrocardiographic and clinical diagnosis of STEMI or NSTEMI * Clear cause of shock that needs immediate intervention (hemorrhage, gastrointestinal bleeding, drugs overdose) * Late evolution of shock state in a patient already treated with known diagnostic tests

Design outcomes

Primary

Measure	Time frame
Correlation between the ultrasound primary diagnosis and the clinical final diagnosis	Clinical judgment on the final diagnosis as deduced from all the data obtained after hospital stay

Countries

Italy

Outcome results