Emergency Thoracic Ultrasound and Clinical Risk Management

NCT02985528 | Completed

• 1 other identifier: TUSMASTER
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

Clinical risk assessment and management is mostly relevant in emergency. Thoracic ultrasound (TUS) has been proposed as an easy-option replacement for chest X-ray (CXR) in Emergency diagnosis of pneumonia, pleural effusion and pneumothorax. Investigators investigated CXR "unforeseen diagnosis", provided by TUS, exploring usefulness and sustainability of telementoring aimed at the management of clinical risk. This observational report includes a period of six months with a proactive concurrent adjunctive telementoring in TUS diagnosis using freely available smartphone applications for the transfer of images and movies.

Conditions

Chest Disorders

Outcome Measures

Primary Outcomes (1)

• level of individual diagnostic accuracy of TUS vs. CXR

  one day

Study Arms (2)

TUS positive

Ultrasound detection of pleuro-pulmonary disease and further diagnostic and imaging when needed

Other: further diagnostic

CXR positive

Radiographic detection of pleuro-pulmonary disease and further diagnostic and imaging when needed

Other: further diagnostic

Interventions

further diagnostic OTHER

further diagnostic procedures - mainly CHEST CT -

Also known as: chest CT

CXR positive; TUS positive

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

observations of a single physician of consecutivo emergency patients, (excluding trauma patients) addressed to a single facility for pain symptoms: of chest, abdomen (with or without distention), lumbar region, neck; and/or dyspnea and/or cough and/or fever with detection of humid or dry lung sounds, chest dullness, of heart and/or pleura-pericardial sounds, and/or jugular congestion.

You may qualify if:

• Patients included in this study have satisfied one of these two criteria of unexpected diagnosis after TUS examination:
• Patients in which chest radiography was not diagnostic, or totally negative, in which thoracic ultrasound suggested evidence of a specific pathology (consolidation, effusion, pneumothorax), later confirmed by CT.
• Patients with detection of a chest disease on chest radiographs, and which a specific condition was further detailed, or differently addressed by the ultrasound procedure, and confirmed by CT.

You may not qualify if:

• patients with non-invasive pulse oximetry lower than 92.0% of Peripheral oxygen saturation (SpO2) , with clinical or instrumental signs of heart failure, in hemodialysis or with severe renal insufficiency, with a known diagnosis of solid or blood tumors.

Sponsors & Collaborators

• Guglielmo Trovato, MD, PhD: lead

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine - Research Project Planning Unit

Study Record Dates

• First Submitted: December 5, 2016
• First Posted: December 7, 2016
• Study Start: February 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: December 7, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share