COVID-19 PneumoniaLungUltrasoundNCT05077202
A New Scoring Model to Diagnose COVID-19 Using Lung Ultrasound in the Emergency Department
An observational study of COVID-19 Pneumonia, run by Zagazig University at 1 site in Egypt.
Trial summary
Mortality in COVID-19 patients is significantly correlated with age, fever duration, cardiac history, and B-profile and areas of consolidation in LUS. However, it is negatively correlated with initial O2 saturation and ejection fraction. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- COVID-19 Pneumonia
- What is being tested?
- ultra sound
- Type of treatment
- Medical device
- How many people
- 82 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Mar 2020to 19 Aug 2020
- How long will I take part?
- 2 Months
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: covid19 pneumonia at emergency room
Who may be able to join
- covid19 patients at emergency room.
Who cannot join
- patients with congestive heart failure (n= 7), (ii) patients with known interstitial lung fibrosis (n= 4), and (iii) patients with poor echo-window (n= 4).
Trial locations and contacts
1 site in 1 country.
About this study
Mortality in COVID-19 patients is significantly correlated with age, fever duration, cardiac history, and B-profile and areas of consolidation in LUS. However, it is negatively correlated with initial O2 saturation and ejection fraction. This study was aiming to design a new scoring model to diagnose COVID-19 using bedside lung ultrasound (LUS) in the emergency department (ED).
Read the detailed description
Patients:
The study recruited all patient with pulmonary symptoms and presented to ED between 27th March 2020 and 17th May 2020. Exclusion criteria were (i) patients with congestive heart failure (n= 7), (ii) patients with known interstitial lung fibrosis (n= 4), and (iii) patients with poor echo-window (n= 4). Patients were seen first at ED where they underwent the required investigations and then classified. Patients were questioned about symptoms suspecting COVID-19 infection. Those who met the suspected clinical and investigational criteria were given a standard mask and were rapidly transferred safely to a separate waiting and isolation area with available infrastructure and tools for hand and respiratory hygiene practice. If the patient was proved to be positive for COVID-19, he was sent to quarantine. For negative patients, they were admitted to intermediate or ICU according to their clinical status. All recruited patients underwent the followings: complete blood count (CBC), arterial blood gas (ABGs), RT-PCR assay to detect COVID-19, chest X-ray, chest CT, LUS, and echocardiography (according to its availability, with precautions for the operators and the probe similar to those exerted to LUS).
LUS examination:
Two trained medical personnel, one ICU physician and one ICU nurse, entered the isolation room respecting all the preventive measures for respiratory, droplet, and contact isolation provided by the world health organization for the COVID-19 outbreak. The ultrasound probe and the tablet were put in two different sterile, plastic probe and tablet covers. Imaging was performed using a curvilinear probe (2-5 MHz) with different devices according to the availability in each centre. Six-point LUS (three in each hemithorax) was performed as described in the bedside lung ultrasonography in emergency (BLUE) protocol [13].
Statistical analysis:
Statistical analysis included comparing different parameters between COVID-19 positive-patients and COVID-19 negative-patients, using independent t-test for numerical variables and chi-square for categorical variables. All significantly different variables were entered in a forward stepwise binary logistic regression analysis to select the best model. After selecting the best model. The variable chosen in the last step was weighed using the odds ratios (ORs) calculated from the regression coefficient (β) for each variable, the ORs were multiplied by 0.125 to calculate a score for each variable and the number was rounded to the nearest integer giving of scoring system of 10 points. All study patients were scored. The cutoff point of the score was calculated using ROC analysis, and calculation of sensitivity and specificity was performed. Also, variables associated with mortality in COVID-19 positive were entered in a forward binary logistic regression, which selected the best model and the ORs were calculated for each variable using the regression coefficient (β). Before adding the variables in the regression analysis, the determination of the proper cutoff values of different contentious variables was done using ROC analysis. Patient Data were entered, checked, and analyzed using SPSS for Windows version 16 (SPSS, Inc. Chicago, IL, USA). For all the above mentioned statistical tests, the threshold of significance is fixed at a 5% level (p < 0.05).
- Conditions
- COVID-19 Pneumonia
- Being tested
- ultra sound
- Keywords
- lung ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultra soundDevice
chest ultrasound
| Study group | Role | What they receive |
|---|---|---|
| ultra sound | lung ultrasound Receives: Device: ultra sound | |
| ct chest | patients had done CT chest already and we receive it from hospital files |
What is being measured
The primary outcome is the main question the study is designed to answer.
lung ultra sound criteria for covid19 pneumonia
Measured: about 2 months
areas of consolidation in COVID-19
Measured: about 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start27 Mar 2020
- Primary completion17 May 2020
- Study completion19 Aug 2020
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 82 participants (actual)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Waleed Mansour, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05077202
- Sponsor's protocol ID
- 6930
- Acronym
- LungUltrasound
- Status last verified
- Oct 2021
- First submitted
- 7 Oct 2021
- Last updated
- 14 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: research
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Scoring Model to Diagnose COVID-19 Using Lung Ultrasound in the Emergency Department
- ClinicalTrials.gov ID
- NCT05077202
- Acronym / sponsor ID
- LungUltrasound / 6930
- Conditions
- COVID-19 Pneumonia
- Keywords
- lung ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 27 Mar 2020 (actual)
- Primary completion
- 17 May 2020 (actual)
- Study completion
- 19 Aug 2020 (actual)
- First posted
- 14 Oct 2021 (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.
Mortality in COVID-19 patients is significantly correlated with age, fever duration, cardiac history, and B-profile and areas of consolidation in LUS. However, it is negatively correlated with initial O2 saturation and ejection fraction. This study was aiming to design a new scoring model to diagnose COVID-19 using bedside lung ultrasound (LUS) in the emergency department (ED).
Detailed description
Patients:
The study recruited all patient with pulmonary symptoms and presented to ED between 27th March 2020 and 17th May 2020. Exclusion criteria were (i) patients with congestive heart failure (n= 7), (ii) patients with known interstitial lung fibrosis (n= 4), and (iii) patients with poor echo-window (n= 4). Patients were seen first at ED where they underwent the required investigations and then classified. Patients were questioned about symptoms suspecting COVID-19 infection. Those who met the suspected clinical and investigational criteria were given a standard mask and were rapidly transferred safely to a separate waiting and isolation area with available infrastructure and tools for hand and respiratory hygiene practice. If the patient was proved to be positive for COVID-19, he was sent to quarantine. For negative patients, they were admitted to intermediate or ICU according to their clinical status. All recruited patients underwent the followings: complete blood count (CBC), arterial blood gas (ABGs), RT-PCR assay to detect COVID-19, chest X-ray, chest CT, LUS, and echocardiography (according to its availability, with precautions for the operators and the probe similar to those exerted to LUS).
LUS examination:
Two trained medical personnel, one ICU physician and one ICU nurse, entered the isolation room respecting all the preventive measures for respiratory, droplet, and contact isolation provided by the world health organization for the COVID-19 outbreak. The ultrasound probe and the tablet were put in two different sterile, plastic probe and tablet covers. Imaging was performed using a curvilinear probe (2-5 MHz) with different devices according to the availability in each centre. Six-point LUS (three in each hemithorax) was performed as described in the bedside lung ultrasonography in emergency (BLUE) protocol [13].
Statistical analysis:
Statistical analysis included comparing different parameters between COVID-19 positive-patients and COVID-19 negative-patients, using independent t-test for numerical variables and chi-square for categorical variables. All significantly different variables were entered in a forward stepwise binary logistic regression analysis to select the best model. After selecting the best model. The variable chosen in the last step was weighed using the odds ratios (ORs) calculated from the regression coefficient (β) for each variable, the ORs were multiplied by 0.125 to calculate a score for each variable and the number was rounded to the nearest integer giving of scoring system of 10 points. All study patients were scored. The cutoff point of the score was calculated using ROC analysis, and calculation of sensitivity and specificity was performed. Also, variables associated with mortality in COVID-19 positive were entered in a forward binary logistic regression, which selected the best model and the ORs were calculated for each variable using the regression coefficient (β). Before adding the variables in the regression analysis, the determination of the proper cutoff values of different contentious variables was done using ROC analysis. Patient Data were entered, checked, and analyzed using SPSS for Windows version 16 (SPSS, Inc. Chicago, IL, USA). For all the above mentioned statistical tests, the threshold of significance is fixed at a 5% level (p < 0.05).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ultra sound | – | Device: ultra soundlung ultrasound |
| ct chest | – | –patients had done CT chest already and we receive it from hospital files |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- covid19 pneumonia at emergency room
Key inclusion criteria (1 listed)
- covid19 patients at emergency room.
Key exclusion criteria (1 listed)
- patients with congestive heart failure (n= 7), (ii) patients with known interstitial lung fibrosis (n= 4), and (iii) patients with poor echo-window (n= 4).
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 |
|---|---|---|
| ultra soundchest ultrasound | Device | ultra sound |
Primary outcome
lung ultra sound criteria for covid19 pneumonia
Time frame: about 2 months
areas of consolidation in COVID-19
Time frame: about 2 months
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 14 Oct 2021.
- Individual participant dataSharing planned: No. research
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Zagazig University at 1 site in Egypt.
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: finished, as of the sponsor's last update on 14 Oct 2021. 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 Egypt. 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?
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?
lung ultra sound criteria for covid19 pneumonia (time frame: about 2 months). The study lists 2 primary outcomes in all. 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 14 Oct 2021.