Ultrasound in Undifferentiated Hypotension

Completed

• Conditions: Hypotension

• Registration Number: NCT01572571
• Lead Sponsor: San Luigi Gonzaga Hospital

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 Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-04-04
• Study First Submitted QC: 2012-04-05
• Study First Posted: 2012-04-06
• Status Verified: 2013-12
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Last Update Submitted: 2013-12-18
• Last Update Posted: 2013-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

San Luigi Gonzaga University Hospital, Department of Emergency Medicine; 🇮🇹 Orbassano, Torino, Italy