Ultrasound in Undifferentiated Hypotension (US-UHP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Giovanni Volpicelli, San Luigi Gonzaga Hospital
ClinicalTrials.gov Identifier:
NCT01572571
First received: April 4, 2012
Last updated: December 18, 2013
Last verified: December 2013
  Purpose

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).

Condition
Hypotension

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Focused Multiorgan Ultrasound in the Emergency Evaluation of Undifferentiated Hypotension

Resource links provided by NLM:


Further study details as provided by San Luigi Gonzaga Hospital:

Primary Outcome Measures:
  • Correlation between the ultrasound primary diagnosis and the clinical final diagnosis [ Time Frame: Clinical judgment on the final diagnosis as deduced from all the data obtained after hospital stay ] [ Designated as safety issue: Yes ]

Enrollment: 100
Study Start Date: December 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients presenting to the Emergency Department with undifferentiated hypotension

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01572571

Locations
Italy
San Luigi Gonzaga University Hospital, Department of Emergency Medicine
Orbassano, Torino, Italy, 10043
Sponsors and Collaborators
San Luigi Gonzaga Hospital
Investigators
Principal Investigator: Giovanni Volpicelli, MD San Luigi Gonzaga Hospital
  More Information

Publications:
Responsible Party: Giovanni Volpicelli, Principal Investigator, San Luigi Gonzaga Hospital
ClinicalTrials.gov Identifier: NCT01572571     History of Changes
Other Study ID Numbers: SLG-182/2011
Study First Received: April 4, 2012
Last Updated: December 18, 2013
Health Authority: Italy: National Bioethics Committee

Keywords provided by San Luigi Gonzaga Hospital:
Emergency ultrasound
Focused ultrasound
Point-of-care ultrasound
Undifferentiated hypotension

Additional relevant MeSH terms:
Hypotension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 16, 2014