NCT01287429

Brief Summary

Dyspnea is a frequent symptom in patients admitted to the Emergency Department (ED); discriminating between cardiogenic and non-cardiogenic dyspnea is a common clinical dilemma. The initial diagnostic work-out is often not very accurate in defining the etiology and the underlying pathophysiology. In the last years, lung ultrasound (US) has emerged as a useful real-time bedside diagnostic tool in the critical patient. The aim of this study was to evaluate the accuracy, reproducibility, and diagnostic impact of pleural and lung US, performed by emergency physicians at the time of patient first presentation to the ED, in identifying cardiac causes of acute dyspnea.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,005

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2010

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 1, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

November 20, 2012

Status Verified

October 1, 2010

Enrollment Period

2 years

First QC Date

January 28, 2011

Last Update Submit

November 19, 2012

Conditions

Keywords

Ultrasonography

Study Arms (1)

acute dyspnea

Other: lung and pleural ultrasound

Interventions

After the initial diagnostic work-out (medical history, physical examination, EKG, arterious blood gas), the emergency physician will classify dyspnoea in cardiogenic or respiratory dyspnoea and write it down in a specific form (clinical form). Immediately after this, lung and pleural ultrasound will be performed: the physician will describe it and evaluate the etiology again (integrated evaluation form). Then a chest X-ray evaluation will be performed for each patient.

acute dyspnea

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Hospital Emergency Departments sample

You may qualify if:

  • Patients had to present to the ED with a principal complaint of shortness of breath, defined as either the sudden onset of dyspnea with no history of chronic dyspnea or an increase in the severity of chronic dyspnea in the last 48 hours;
  • Presence of an emergency physician with lung US experience at the time of enrollment;
  • US examination within 30 minutes after the start of the clinical evaluation.

You may not qualify if:

  • Dyspnea cases clearly due to neither cardiogenic nor respiratory etiology will considered not eligible.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Emergency Department - AOU San Giovanni Battista

Turin, Italy, 10126, Italy

Location

Emergency Medicine & Surgery Unit - Cardinal Massaia Hospital

Asti, 14100, Italy

Location

Emergency Department - AO Santa Croce e Carle

Cuneo, Italy

Location

Emergency Medicine Unit - AOU San Luigi Gonzaga

Orbassano, 10043, Italy

Location

Emergency Medicine & Surgery Unit - Pinerolo General Hospital, ASL TO 3

Pinerolo, 10064, Italy

Location

Emergency Medicine and Surgery Unit- AO Mauriziano

Turin, 10128, Italy

Location

Emergency Medicine & Surgery Unit - Martini Hospital, ASL TO 2

Turin, 10141, Italy

Location

Related Publications (25)

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    PMID: 17316468BACKGROUND
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    PMID: 19697100BACKGROUND
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    PMID: 18442425BACKGROUND
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    PMID: 19183402BACKGROUND
  • Pivetta E, Goffi A, Lupia E, Tizzani M, Porrino G, Ferreri E, Volpicelli G, Balzaretti P, Banderali A, Iacobucci A, Locatelli S, Casoli G, Stone MB, Maule MM, Baldi I, Merletti F, Cibinel GA, Baron P, Battista S, Buonafede G, Busso V, Conterno A, Del Rizzo P, Ferrera P, Pecetto PF, Moiraghi C, Morello F, Steri F, Ciccone G, Calasso C, Caserta MA, Civita M, Condo' C, D'Alessandro V, Del Colle S, Ferrero S, Griot G, Laurita E, Lazzero A, Lo Curto F, Michelazzo M, Nicosia V, Palmari N, Ricchiardi A, Rolfo A, Rostagno R, Bar F, Boero E, Frascisco M, Micossi I, Mussa A, Stefanone V, Agricola R, Cordero G, Corradi F, Runzo C, Soragna A, Sciullo D, Vercillo D, Allione A, Artana N, Corsini F, Dutto L, Lauria G, Morgillo T, Tartaglino B, Bergandi D, Cassetta I, Masera C, Garrone M, Ghiselli G, Ausiello L, Barutta L, Bernardi E, Bono A, Forno D, Lamorte A, Lison D, Lorenzati B, Maggio E, Masi I, Maggiorotto M, Novelli G, Panero F, Perotto M, Ravazzoli M, Saglio E, Soardo F, Tizzani A, Tizzani P, Tullio M, Ulla M, Romagnoli E; SIMEU Group for Lung Ultrasound in the Emergency Department in Piedmont. Lung Ultrasound-Implemented Diagnosis of Acute Decompensated Heart Failure in the ED: A SIMEU Multicenter Study. Chest. 2015 Jul;148(1):202-210. doi: 10.1378/chest.14-2608.

MeSH Terms

Conditions

DyspneaHeart Failure

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular Diseases

Study Officials

  • Emanuele Pivetta

    Cancer Epidemiology Unit - University of Turin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 28, 2011

First Posted

February 1, 2011

Study Start

October 1, 2010

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

November 20, 2012

Record last verified: 2010-10

Locations