Reliability of a Pocket Sized Ultrasound Scanner in the Evaluation Covid-19 Pneumonia
USCovid
Comparison Between a Pocket Sized and a High End Ultrasound Scanner in the Evaluation of Lung Involvement in Patients With Covid-19 Pneumonia
1 other identifier
observational
34
1 country
1
Brief 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 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 10, 2020
CompletedFirst Submitted
Initial submission to the registry
June 12, 2020
CompletedFirst Posted
Study publicly available on registry
June 16, 2020
CompletedJune 16, 2020
June 1, 2020
3 months
June 12, 2020
June 13, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
1 day
Interventions
Standardized lung ultrasound scan with two different instruments
Eligibility Criteria
Patients admitted to hospital ward with a diagnosis of Covid-19 preumonia, confirmed by a positive rtPCR swab and radiography
You may qualify if:
- Admitted to hospital ward with a diagnosis of Covid-19 preumonia, confirmed by a positive rtPCR swab and radiography
You may not qualify if:
- Unable/unwilling to cooperate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Azienda Ospedaliera Universitaria Senese
Siena, Si, 53100, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Bennett, MD
Azienda Ospedaliera Universitaria Senese
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor of respiratory diseases
Study Record Dates
First Submitted
June 12, 2020
First Posted
June 16, 2020
Study Start
March 15, 2020
Primary Completion
June 10, 2020
Study Completion
June 10, 2020
Last Updated
June 16, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- from the month of July, for one year
- Access Criteria
- on request by email
The whole anonymized dataset could be shared