Chest DisordersCLINRISKETUSNCT02985528
Emergency Thoracic Ultrasound and Clinical Risk Management
An observational study of Chest Disorders, run by Guglielmo Trovato, MD, PhD.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Chest Disorders
- What is being tested?
- further diagnostic
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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.
Read the detailed description
The present study describes a six months period of specialist activity of an Emergency Department physician. The aim is to display the performance in the subsets of difficult or unexpected thoracic ultrasound imaging performed by TUS, in a context with the prompt availability of all radiological facilities. The interaction of TUS telementoring, using WhatsApp® or Skype®, provided by another colleague, in another city and hospital, with a greater specific expertise in TUS, was devised to assure a concurrent mentorship by the School. This training has included a subsequent revaluation of clinical cases by the Ultrasound Course Lecturer in TUS and by the Director of the School of Clinical Ultrasound, with a reappraisal overview of all the available information. The approach was clinical and instrumental, and included:
- clinical history; B. clinical examination of chest, neck, joints and abdomen; C. sequential ultrasound examination of the abdomen, thorax, pericardium; D. focus on pain symptoms: of chest, abdomen (with or without distention), lumbar region, neck; E. focus on 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, checking also the mobility of the diaphragm and evaluating the collapsibility of the cava vein.
TUS was generally conducted with the patient in a sitting position, although the few patients (predominantly children), likely to experience severe discomfort during the procedure, were scanned in a semi-supine position. A systematic examination of all intercostal spaces was performed and TUS images, if present, were assessed for the number, location, shape, size, and breath-dependent changes in consolidation areas. Two main types of pattern of lung consolidation attributable to pneumonia were defined: hypoechoic consolidation and mixed consolidation. The presence of air bronchogram, fluid bronchogram, and basal pleural effusion was also reported. The size of the consolidation area was measured longitudinally and transversally, using the longest measurement, i.e., the maximal length of the consolidation area visible by TUS, for data analysis. For the purpose of this report, details on the measurements are not detailed.
The second opinion was provided outside the Hospital facility by a mentor (FMT), expert in Clinical Ultrasound, answering to the questions related to the images of videoclips of the actual patient in emergency. Images and movies were sent by WhatsApp. Reappraisal was performed subsequently, using all the available imaging - photos and videoclips, the clinical records and the outcome information, as obtainable by a short-term follow-up.
- Conditions
- Chest Disorders
- Being tested
- further diagnostic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
further diagnosticOther
Also called chest CT
further diagnostic procedures - mainly CHEST CT -
| Study group | Role | What they receive |
|---|---|---|
| TUS positive | Ultrasound detection of pleuro-pulmonary disease and further diagnostic and imaging when needed Receives: Other: further diagnostic | |
| CXR positive | Radiographic detection of pleuro-pulmonary disease and further diagnostic and imaging when needed Receives: Other: further diagnostic |
What is being measured
The primary outcome is the main question the study is designed to answer.
level of individual diagnostic accuracy of TUS vs. CXR
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study startFeb 2016
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guglielmo Trovato, MD, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Guglielmo Trovato, MD, PhD, Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02985528
- Sponsor's protocol ID
- TUSMASTER
- Acronym
- CLINRISKETUS
- Status last verified
- Dec 2016
- First submitted
- 5 Dec 2016
- Last updated
- 7 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Thoracic Ultrasound and Clinical Risk Management
- ClinicalTrials.gov ID
- NCT02985528
- Acronym / sponsor ID
- CLINRISKETUS / TUSMASTER
- Conditions
- Chest Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Guglielmo Trovato, MD, PhDUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 7 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The present study describes a six months period of specialist activity of an Emergency Department physician. The aim is to display the performance in the subsets of difficult or unexpected thoracic ultrasound imaging performed by TUS, in a context with the prompt availability of all radiological facilities. The interaction of TUS telementoring, using WhatsApp® or Skype®, provided by another colleague, in another city and hospital, with a greater specific expertise in TUS, was devised to assure a concurrent mentorship by the School. This training has included a subsequent revaluation of clinical cases by the Ultrasound Course Lecturer in TUS and by the Director of the School of Clinical Ultrasound, with a reappraisal overview of all the available information. The approach was clinical and instrumental, and included:
- clinical history; B. clinical examination of chest, neck, joints and abdomen; C. sequential ultrasound examination of the abdomen, thorax, pericardium; D. focus on pain symptoms: of chest, abdomen (with or without distention), lumbar region, neck; E. focus on 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, checking also the mobility of the diaphragm and evaluating the collapsibility of the cava vein.
TUS was generally conducted with the patient in a sitting position, although the few patients (predominantly children), likely to experience severe discomfort during the procedure, were scanned in a semi-supine position. A systematic examination of all intercostal spaces was performed and TUS images, if present, were assessed for the number, location, shape, size, and breath-dependent changes in consolidation areas. Two main types of pattern of lung consolidation attributable to pneumonia were defined: hypoechoic consolidation and mixed consolidation. The presence of air bronchogram, fluid bronchogram, and basal pleural effusion was also reported. The size of the consolidation area was measured longitudinally and transversally, using the longest measurement, i.e., the maximal length of the consolidation area visible by TUS, for data analysis. For the purpose of this report, details on the measurements are not detailed.
The second opinion was provided outside the Hospital facility by a mentor (FMT), expert in Clinical Ultrasound, answering to the questions related to the images of videoclips of the actual patient in emergency. Images and movies were sent by WhatsApp. Reappraisal was performed subsequently, using all the available imaging - photos and videoclips, the clinical records and the outcome information, as obtainable by a short-term follow-up.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TUS positive | – | Other: further diagnosticUltrasound detection of pleuro-pulmonary disease and further diagnostic and imaging when needed |
| CXR positive | – | Other: further diagnosticRadiographic detection of pleuro-pulmonary disease and further diagnostic and imaging when needed |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Patients included in this study have satisfied one of these two criteria of unexpected diagnosis after TUS examination:
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| further diagnosticAlso: chest CTfurther diagnostic procedures - mainly CHEST CT - | Other | CXR positive, TUS positive |
Primary outcome
level of individual diagnostic accuracy of TUS vs. CXR
Time frame: one day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2016.
- Individual participant dataSharing planned: No
Related trials for Chest Disorders
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Chest Disorders, run by Guglielmo Trovato, MD, PhD.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
level of individual diagnostic accuracy of TUS vs. CXR (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2016.