Ultrasound in Undifferentiated Hypotension | NCT01572571

Studies
Ultrasound in Undifferentiated Hypotension

NCT01572571

Sponsor

San Luigi Gonzaga Hospital

Status

Completed

Last Update Posted

Dec 19, 2013Estimated

Enrollment

100Actual

Phase

Not provided

Conditions

Hypotension

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2011

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Apr 4, 2012

First Submission Date that Met QC Criteria

Apr 5, 2012

First Posted Date

Apr 6, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 18, 2013

Last Update Posted Date

Dec 19, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Giovanni Volpicelli, Principal Investigator, San Luigi Gonzaga HospitalPrincipal Investigator

Lead Sponsor

San Luigi Gonzaga HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients presenting to the Emergency Department with undifferentiated hypotension

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Giovanni Volpicelli, MD	San Luigi Gonzaga Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
San Luigi Gonzaga University Hospital, Department of Emergency Medicine		Orbassano	Torino	10043	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19164614	Background	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.
15286547

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases