Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
100 participants
OBSERVATIONAL
2011-12-31
2013-12-31
Brief Summary
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* 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
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Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* At least one of the following symptoms:
* Unresponsive
* Syncope
* Impaired mental status
* Respiratory distress
* Severe malaise and fatigue
Exclusion Criteria
* 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
16 Years
ALL
No
Sponsors
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San Luigi Gonzaga Hospital
OTHER
Responsible Party
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Giovanni Volpicelli
Principal Investigator
Principal Investigators
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Giovanni Volpicelli, MD
Role: PRINCIPAL_INVESTIGATOR
San Luigi Gonzaga Hospital
Locations
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San Luigi Gonzaga University Hospital, Department of Emergency Medicine
Orbassano, Torino, Italy
Countries
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References
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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.
Other Identifiers
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SLG-182/2011
Identifier Type: -
Identifier Source: org_study_id