Trial record 4 of 1030 for:    chest x ray

Comparison Between Lung Ultrasound and Chest Radiography for Acute Dyspnea

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of Turin, Italy
Sponsor:
Information provided by (Responsible Party):
Enrico Lupia, MD, PhD, University of Turin, Italy
ClinicalTrials.gov Identifier:
NCT02105207
First received: March 27, 2014
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

For patients presenting to the Emergency Department with acute dyspnea, emergency physicians will be asked to categorize the diagnosis as acute decompensated heart failure or non-cardiogenic shortness of breath a) after the initial clinical assessment, and b) after performing lung ultrasound (LUS) for LUS arm or after chest radiography (CXR) and natriuretic peptide (NT-pro BNP) results for CXR arm. All patients will undergo CXR, those enrolled in the LUS arm, after sonographic evaluation. After discharge, the cause of patient's dyspnea will be determined by independent review of the entire medical records performed by two emergency physicians. In case of disagreement, a third expert physician will review entire medical records, and adjudicate the case.


Condition Intervention
Dyspnea
Congestive Heart Failure
Other: Lung Ultrasound
Other: Chest Radiography

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Comparison Between Lung Ultrasound and Chest Radiography for Differential Diagnosis of Acute Dyspnea in the Emergency Department

Resource links provided by NLM:


Further study details as provided by University of Turin, Italy:

Primary Outcome Measures:
  • Accuracy of Lung Ultrasound and Chest Radiography in dyspnoeic patients [ Time Frame: Accuracy will be measured at the end of clinical evaluation in the Emergency Department, an expected average of 2 hours. ] [ Designated as safety issue: No ]
    Accuracy of lung ultrasound and chest radiography will be measured using as gold standard the independent evaluation of the entire medical records by two expert emergency physicians blinded to the lung ultrasound results and radiographic reports (digitalized chest radiography images will be available).


Estimated Enrollment: 504
Study Start Date: January 2014
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lung Ultrasound Other: Lung Ultrasound
Lung ultrasound evaluation is performed after clinical assessment and before chest radiography
Experimental: Chest Radiography Other: Chest Radiography
Chest Radiography is performed after clinical evaluation without using ultrasound assessment

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • acute dyspnea as chief complaint
  • presence of an emergency physician skilled in lung ultrasound at evaluation time

Exclusion Criteria:

  • mechanical ventilation ongoing at enrolment time
  • dyspnea clearly related to a different aetiology (e.g. trauma, anxiety, etc)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02105207

Contacts
Contact: Enrico Lupia, MD, PhD +390116337184 enrico.lupia@unito.it

Locations
Italy
AOU Città della Salute e della Scienza di Torino Recruiting
Turin, Italy, 10126
Contact: Enrico Lupia, MD, PhD    +390116337184    enrico.lupia@unito.it   
Principal Investigator: Enrico Lupia, MD         
Sub-Investigator: Pietro Tizzani, MD         
Sub-Investigator: Maria Tizzani, MD         
Sub-Investigator: Giulio Porrino, MD         
Sub-Investigator: Enrico Ferreri, MD         
Sub-Investigator: Federica Bovaro         
Sub-Investigator: Emanuele Pivetta, MD         
Sub-Investigator: Ottavio Davini, MD         
Sub-Investigator: Paolo Quaglia, MD         
Sponsors and Collaborators
University of Turin, Italy
Investigators
Principal Investigator: Enrico Lupia, MD, PhD University of Turin
  More Information

Publications:

Responsible Party: Enrico Lupia, MD, PhD, Assistant Professor, University of Turin, Italy
ClinicalTrials.gov Identifier: NCT02105207     History of Changes
Other Study ID Numbers: iLUS-RCT
Study First Received: March 27, 2014
Last Updated: April 4, 2014
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Dyspnea
Heart Failure
Cardiovascular Diseases
Heart Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory

ClinicalTrials.gov processed this record on October 29, 2014