Covid-19 PneumoniaUSCovidNCT04433000
Reliability of a Pocket Sized Ultrasound Scanner in the Evaluation Covid-19 Pneumonia
An observational study of Covid-19 Pneumonia, run by University of Siena at 1 site in Italy.
Trial summary
Ultrasound imaging of the lung (LUS) and associated tissues has demonstrated clinical utility in COVID-19 patients. The aim of the present study was to evaluate the possibilities of a portable pocket-sized ultrasound scanner in the evaluation of lung involvement in patients with COVID-19 pneumonia, in comparison with… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Covid-19 Pneumonia
- What is being tested?
- Butterfly
- How many people
- 34 participants
- Where
- 1 siteItaly
- Study dates
- 15 Mar 2020to 10 Jun 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients admitted to hospital ward with a diagnosis of Covid-19 preumonia, confirmed by a positive rtPCR swab and radiography
Who may be able to join
- Admitted to hospital ward with a diagnosis of Covid-19 preumonia, confirmed by a positive rtPCR swab and radiography
Who cannot join
- Unable/unwilling to cooperate
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliera Universitaria Senese
Siena, Si, 53100
Sestini Piersante, MD, +390577586710, piersante.sestini@unisi.it
About this study
Official title: Comparison Between a Pocket Sized and a High End Ultrasound Scanner in the Evaluation of Lung Involvement in Patients With Covid-19 Pneumonia
Ultrasound imaging of the lung (LUS) and associated tissues has demonstrated clinical utility in COVID-19 patients. The aim of the present study was to evaluate the possibilities of a portable pocket-sized ultrasound scanner in the evaluation of lung involvement in patients with COVID-19 pneumonia, in comparison with a high end ultrasound scanner.
Statisical analysis will be performed with Stata for Windows V 16 (Stata corp, Texas College, TX). Power size estimation using Medcalc 19.3.1, (MedCalc Software Ltd, Ostenda, B) showed that hat 34 patients would be required for the comparison of the two methods using the Bland-Altman method assuming a mean difference in total score of 1±1, a false positive rate (α) of 0.05 and a false negative rate of 0.1 (β=0.9).
Read the detailed description
Coronavirus disease 2019 (COVID-19), caused by infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), emerged in China in December 2019 and quickly spread all over the globe. The clinical features are fever, dyspnoea, dry cough, fatigue and diarrhoea (1). Pharyngodynia, nasal congestion, rhinorrhoea and anosmia have also been reported . Interstitial pneumonia is very common and a high percentage of patients (9-11%) develop severe acute respiratory distress syndrome (ARDS) and require intensive care. Current therapeutic strategy involves agents counteracting viral invasion and replication, and inhibitors of cytokine-sustained inflammatory reactions. No specific antiviral therapy has yet been identified.
Ultrasound imaging of the lung (LUS) and associated tissues has demonstrated clinical utility in COVID-19 patients, due to the typical sonographic characteristics of affected lungs. It provides indications for clinical decisions and the management of associated respiratory failure and lung injury.
The aim of the present study was to evaluate the possibilities of a portable pocket-sized ultrasound scanner in the evaluation of lung involvement in patients with COVID-19 pneumonia.
We will perform 34 LUS (lung ultrasound scan) evaluations on patients admitted to the COVID Unit of Siena University Hospital with symptoms compatible with COVID-19, a positive SARS-CoV-2 nasal-pharyngeal swab and radiological evidence of interstitial pneumonia.
The patients will be divided into three severity categories based on respiratory impairment: Mild PaO2/FiO2 > 300 in room air or oxygen flow; Moderate PaO2/FiO2 between 150 and 300 in room air or oxygen-therapy, CPAP, NIV or HFNC; Severe PaO2/FiO2 < 150 on oxygen-therapy, CPAP, NIV, HFNC or mechanical ventilation.
The lung ultrasound scans will be performed on the same day with a standard ultrasound scanner (GE Healthcare, Venue GO) and a pocket-sized ultrasound scanner (Butterfly Network Inc., Butterfly iQ) for clinical purposes; lung preset will be used with both scanners. Up to six regions of the chest will be identified: anterosuperior (A); anteroinferior (B); lateralsuperior (C); lateralinferior (D); posterosuperior (E); posteroinferior (F). One of four different aeration patterns will be recorded according to a specific scoring system: A = 0 points (normal aeration, presence of lung sliding with A lines or less than two isolated B lines), B1 = 1 point (moderate loss of lung aeration, multiple well-defined B lines), B2 = 2 points (severe loss of lung aeration, multiple coalescent B lines), C = 3 points (lung consolidation and tissue-like pattern). Pleural effusion and pneumothorax were also recorded. A score of 0 was normal and 36 was the worst. Due to clinical conditions, the upper posterior region (E) could not be explored in some patients, so the mean of the regions explored will be calculated for the purposes of statistical analysis (total sum (0 to 36) divided by number of regions explored (5 or 6 on each side).
- Conditions
- Covid-19 Pneumonia
- Being tested
- Butterfly
- Keywords
- Covid-19, pneumonia, lung ultrasound
- Medical subject headings
- COVID-19, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ButterflyDiagnostic test
Also called GE Healthcare Venue GO
Standardized lung ultrasound scan with two different instruments
What is being measured
The primary outcome is the main question the study is designed to answer.
Bland-Altman estimate of bias and Limits of Agreement (LoA) of patient mean scores obtained with the two instruments
The more widely accepted measure of agreement beteen two instruments. Bland JM, Altman DG (1986) Statistical method for assessing agreement between two methods of clinical measurement. The Lancet i:307-310
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start15 Mar 2020
- Primary completion10 Jun 2020
- Study completion10 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid-19 PneumoniaStudies 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
- Retrospective
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Siena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Piersante Sestini, University of Siena
- Investigators
- David Bennett, MD, Principal investigator, Azienda Ospedaliera Universitaria Senese
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04433000
- Sponsor's protocol ID
- USCovid
- Acronym
- USCovid
- Status last verified
- Jun 2020
- First submitted
- 12 Jun 2020
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The whole anonymized dataset could be shared
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between a Pocket Sized and a High End Ultrasound Scanner in the Evaluation of Lung Involvement in Patients With Covid-19 Pneumonia
- ClinicalTrials.gov ID
- NCT04433000
- Acronym / sponsor ID
- USCovid / USCovid
- Conditions
- Covid-19 Pneumonia
- Keywords
- Covid-19, pneumonia, lung ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- University of SienaUniversity, hospital or other
- Study start
- 15 Mar 2020 (actual)
- Primary completion
- 10 Jun 2020 (actual)
- Study completion
- 10 Jun 2020 (estimated)
- First posted
- 16 Jun 2020 (actual)
- 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.
Ultrasound imaging of the lung (LUS) and associated tissues has demonstrated clinical utility in COVID-19 patients. The aim of the present study was to evaluate the possibilities of a portable pocket-sized ultrasound scanner in the evaluation of lung involvement in patients with COVID-19 pneumonia, in comparison with a high end ultrasound scanner.
Statisical analysis will be performed with Stata for Windows V 16 (Stata corp, Texas College, TX). Power size estimation using Medcalc 19.3.1, (MedCalc Software Ltd, Ostenda, B) showed that hat 34 patients would be required for the comparison of the two methods using the Bland-Altman method assuming a mean difference in total score of 1±1, a false positive rate (α) of 0.05 and a false negative rate of 0.1 (β=0.9).
Detailed description
Coronavirus disease 2019 (COVID-19), caused by infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), emerged in China in December 2019 and quickly spread all over the globe. The clinical features are fever, dyspnoea, dry cough, fatigue and diarrhoea (1). Pharyngodynia, nasal congestion, rhinorrhoea and anosmia have also been reported . Interstitial pneumonia is very common and a high percentage of patients (9-11%) develop severe acute respiratory distress syndrome (ARDS) and require intensive care. Current therapeutic strategy involves agents counteracting viral invasion and replication, and inhibitors of cytokine-sustained inflammatory reactions. No specific antiviral therapy has yet been identified.
Ultrasound imaging of the lung (LUS) and associated tissues has demonstrated clinical utility in COVID-19 patients, due to the typical sonographic characteristics of affected lungs. It provides indications for clinical decisions and the management of associated respiratory failure and lung injury.
The aim of the present study was to evaluate the possibilities of a portable pocket-sized ultrasound scanner in the evaluation of lung involvement in patients with COVID-19 pneumonia.
We will perform 34 LUS (lung ultrasound scan) evaluations on patients admitted to the COVID Unit of Siena University Hospital with symptoms compatible with COVID-19, a positive SARS-CoV-2 nasal-pharyngeal swab and radiological evidence of interstitial pneumonia.
The patients will be divided into three severity categories based on respiratory impairment: Mild PaO2/FiO2 > 300 in room air or oxygen flow; Moderate PaO2/FiO2 between 150 and 300 in room air or oxygen-therapy, CPAP, NIV or HFNC; Severe PaO2/FiO2 < 150 on oxygen-therapy, CPAP, NIV, HFNC or mechanical ventilation.
The lung ultrasound scans will be performed on the same day with a standard ultrasound scanner (GE Healthcare, Venue GO) and a pocket-sized ultrasound scanner (Butterfly Network Inc., Butterfly iQ) for clinical purposes; lung preset will be used with both scanners. Up to six regions of the chest will be identified: anterosuperior (A); anteroinferior (B); lateralsuperior (C); lateralinferior (D); posterosuperior (E); posteroinferior (F). One of four different aeration patterns will be recorded according to a specific scoring system: A = 0 points (normal aeration, presence of lung sliding with A lines or less than two isolated B lines), B1 = 1 point (moderate loss of lung aeration, multiple well-defined B lines), B2 = 2 points (severe loss of lung aeration, multiple coalescent B lines), C = 3 points (lung consolidation and tissue-like pattern). Pleural effusion and pneumothorax were also recorded. A score of 0 was normal and 36 was the worst. Due to clinical conditions, the upper posterior region (E) could not be explored in some patients, so the mean of the regions explored will be calculated for the purposes of statistical analysis (total sum (0 to 36) divided by number of regions explored (5 or 6 on each side).
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients admitted to hospital ward with a diagnosis of Covid-19 preumonia, confirmed by a positive rtPCR swab and radiography
Key inclusion criteria (1 listed)
- Admitted to hospital ward with a diagnosis of Covid-19 preumonia, confirmed by a positive rtPCR swab and radiography
Key exclusion criteria (1 listed)
- Unable/unwilling to cooperate
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 |
|---|---|---|
| ButterflyAlso: GE Healthcare Venue GOStandardized lung ultrasound scan with two different instruments | Diagnostic test | – |
Primary outcome
Bland-Altman estimate of bias and Limits of Agreement (LoA) of patient mean scores obtained with the two instruments
Time frame: 1 day
The more widely accepted measure of agreement beteen two instruments. Bland JM, Altman DG (1986) Statistical method for assessing agreement between two methods of clinical measurement. The Lancet i:307-310
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Individual participant dataSharing planned: Yes. The whole anonymized dataset could be shared
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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.
David Bennett, MD principal investigator
Azienda Ospedaliera Universitaria Senese
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid-19 Pneumonia, run by University of Siena at 1 site in Italy.
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 1 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: status not confirmed, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Piersante Sestini, MD (+393356247055, piersante.sestini@unisi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bland-Altman estimate of bias and Limits of Agreement (LoA) of patient mean scores obtained with the two instruments (time frame: 1 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 16 Jun 2020.