Clinical trial NCT01572571: Ultrasound in Undifferentiated Hypotension
Official title: Focused Multiorgan Ultrasound in the Emergency Evaluation of Undifferentiated Hypotension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypotension
Keywords: Emergency ultrasound
Focused ultrasound
Point-of-care ultrasound
Undifferentiated hypotension
Lead sponsor: San Luigi Gonzaga Hospital
Sponsor class: OTHER
First posted: 2012-04-06
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients presenting to the Emergency Department with undifferentiated hypotension

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).


Eligibility criteria: 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

Primary outcomes:
measure: Correlation between the ultrasound primary diagnosis and the clinical final diagnosis
timeFrame: Clinical judgment on the final diagnosis as deduced from all the data obtained after hospital stay
Secondary outcomes:
Other outcomes:
Locations:
city: Orbassano
country: Italy
facility: San Luigi Gonzaga University Hospital, Department of Emergency Medicine
state: Torino
Study officials:
affiliation: San Luigi Gonzaga Hospital
name: Giovanni Volpicelli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1097/01.ccm.0000133017.34137.82.
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. doi: 10.1053/ajem.2001.24481.
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.