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Lung Ultrasound for Acute Dyspnea in Emergency Department

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ClinicalTrials.gov Identifier: NCT01287429
Recruitment Status : Completed
First Posted : February 1, 2011
Last Update Posted : November 20, 2012
Sponsor:
Collaborators:
Azienda Ospedaliera San Giovanni Battista
San Luigi Gonzaga Hospital
Agnelli Hospital, Italy
Azienda Ospedaliera Ordine Mauriziano di Torino
Martini Hospital, Turin, Italy
Ospedale Cardinal Massaia
Ospedale Santa Croce-Carle Cuneo
Information provided by:
University of Turin, Italy

Tracking Information
First Submitted Date January 28, 2011
First Posted Date February 1, 2011
Last Update Posted Date November 20, 2012
Study Start Date October 2010
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Lung Ultrasound for Acute Dyspnea in Emergency Department
Official Title Lung Ultrasound for Acute Dyspnea in Emergency Department - Prospective Multicenter Study on Accuracy, Reproducibility, and Diagnostic Impact of Lung Ultrasound in the Evaluation of Patients With Dyspnea in the Emergency Department
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Hospital Emergency Departments sample
Condition
  • Dyspnea
  • Congestive Heart Failure
Intervention Other: lung and pleural ultrasound
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.
Study Groups/Cohorts acute dyspnea
Intervention: Other: lung and pleural ultrasound
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 13, 2012)
1005
Original Estimated Enrollment
 (submitted: January 28, 2011)
1000
Actual Study Completion Date October 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Dyspnea cases clearly due to neither cardiogenic nor respiratory etiology will considered not eligible.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT01287429
Other Study ID Numbers CEU-UTurin-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Emanuele Pivetta, Cancer Epidemiology Unit - University of Turin
Study Sponsor University of Turin, Italy
Collaborators
  • Azienda Ospedaliera San Giovanni Battista
  • San Luigi Gonzaga Hospital
  • Agnelli Hospital, Italy
  • Azienda Ospedaliera Ordine Mauriziano di Torino
  • Martini Hospital, Turin, Italy
  • Ospedale Cardinal Massaia
  • Ospedale Santa Croce-Carle Cuneo
Investigators
Principal Investigator: Emanuele Pivetta Cancer Epidemiology Unit - University of Turin
PRS Account University of Turin, Italy
Verification Date October 2010