Ultrasound in Undifferentiated Hypotension

Hypotension Clinical Trial

— US-UHP  

Official title:

Focused Multiorgan Ultrasound in the Emergency Evaluation of Undifferentiated Hypotension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01572571
• Other study ID #: SLG-182/2011
• Status: Completed
• Phase: N/A
• First received: April 4, 2012
• Last updated: December 18, 2013
• Start date: December 2011
• Est. completion date: December 2013

Study information

• Verified date: December 2013
• Source: San Luigi Gonzaga Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Bioethics Committee
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypotension

Locations

Country	Name	City	State
Italy	San Luigi Gonzaga University Hospital, Department of Emergency Medicine	Orbassano	Torino

Sponsors (1)

Lead Sponsor	Collaborator
San Luigi Gonzaga Hospital

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes