Ultrasound in Undifferentiated Hypotension (US-UHP)

Focused Multiorgan Ultrasound in the Emergency Evaluation of Undifferentiated Hypotension

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).

Study Overview

• Status: Completed
• Conditions: Hypotension

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Italy
  • Torino
    • Orbassano, Torino, Italy, 10043
      • San Luigi Gonzaga University Hospital, Department of Emergency Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients presenting to the Emergency Department with undifferentiated hypotension

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: San Luigi Gonzaga Hospital

Publications and helpful links

General Publications

• Atkinson PR, McAuley DJ, Kendall RJ, Abeyakoon O, Reid CG, Connolly J, Lewis D. Abdominal and Cardiac Evaluation with Sonography in Shock (ACES): an approach by emergency physicians for the use of ultrasound in patients with undifferentiated hypotension. Emerg Med J. 2009 Feb;26(2):87-91. doi: 10.1136/emj.2007.056242.
• Jones AE, Tayal VS, Sullivan DM, Kline JA. Randomized, controlled trial of immediate versus delayed goal-directed ultrasound to identify the cause of nontraumatic hypotension in emergency department patients. Crit Care Med. 2004 Aug;32(8):1703-8. doi: 10.1097/01.ccm.0000133017.34137.82.
• Rose JS, Bair AE, Mandavia D, Kinser DJ. The UHP ultrasound protocol: a novel ultrasound approach to the empiric evaluation of the undifferentiated hypotensive patient. Am J Emerg Med. 2001 Jul;19(4):299-302. doi: 10.1053/ajem.2001.24481.
• Copetti R, Copetti P, Reissig A. Clinical integrated ultrasound of the thorax including causes of shock in nontraumatic critically ill patients. A practical approach. Ultrasound Med Biol. 2012 Mar;38(3):349-59. doi: 10.1016/j.ultrasmedbio.2011.11.015. Epub 2012 Jan 21.

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: April 4, 2012
• First Submitted That Met QC Criteria: April 5, 2012
• First Posted (Estimate): April 6, 2012

Study Record Updates

• Last Update Posted (Estimate): December 19, 2013
• Last Update Submitted That Met QC Criteria: December 18, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Emergency ultrasound; Focused ultrasound; Point-of-care ultrasound; Undifferentiated hypotension
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: SLG-182/2011

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No