Ultrasound in Undifferentiated Hypotension

NCT01572571 | Completed

• 1 other identifier: SLG-182/2011
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Hypotension

Keywords

Emergency ultrasound; Focused ultrasound; Point-of-care ultrasound; Undifferentiated hypotension

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients presenting to the Emergency Department with undifferentiated hypotension

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• San Luigi Gonzaga Hospital: lead

Study Sites (1)

San Luigi Gonzaga University Hospital, Department of Emergency Medicine

Orbassano, Torino, 10043, Italy

Location

Related 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.

  PMID: 19164614 BACKGROUND

• 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.

  PMID: 15286547 BACKGROUND

• 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.

  PMID: 11447518 BACKGROUND

• 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.

  PMID: 22266231 BACKGROUND

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Giovanni Volpicelli, MD

  San Luigi Gonzaga Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 4, 2012
• First Posted: April 6, 2012
• Study Start: December 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 19, 2013

Record last verified: 2013-12

Locations

IT (1)