COVID-19NCT04577235
Correlation Between Thoracic Ultrasound and Thorax Computed Tomography Scores.
A study testing severity of lung involvement with COVID-19. in people with COVID-19, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
Coronavirus Disease 19 (COVID-19) pandemic has become a global health problem in a short time due to high infection rate and increasing mortality. Since it is not possible to perform thorax computed tomography (CT) and transfer of patients with COVID-19 pneumonia who are followed up in intensive care, diagnosis and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- severity of lung involvement with COVID-19.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jun 2020to 5 Sep 2020
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years of age
Who cannot join
- Under 18 years of age
- Previous lung resection
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpasa Taksim Research and Education Hospital
Istanbul, Gazi̇osmanpaşa, 34255
About this study
Official title: Evaluation of the Correlation Between Thoracic Ultrasound and Thorax Computed Tomography Scores of Patients With Severe COVID 19 Pneumonia in Intensive Care.
Coronavirus Disease 19 (COVID-19) pandemic has become a global health problem in a short time due to high infection rate and increasing mortality. Since it is not possible to perform thorax computed tomography (CT) and transfer of patients with COVID-19 pneumonia who are followed up in intensive care, diagnosis and follow-up by lung ultrasound (LUS) is a great advantage nowadays.The investigators aimed to evaluate the correlation between thoracic CT score and LUS score and to determine its relationship with mortality.
Patients who were admitted to intensive care with the diagnosis of COVID-19 pneumonia, who had an initial thorax CT examination and who underwent LUS during admission to the intensive care unit were included in the study. The demographic characteristics, clinical parameters, prognosis, thorax CT and LUS scores of the patients were recorded prospectively. The characteristics of the survived patients and the patients who died were compared.
Read the detailed description
Thorax CT scoring was performed by an experienced radiologist, while LUS scoring was performed an experienced anaesthesia and reanimation specialist. The demographic characteristics, clinical parameters, prognosis, thorax CT and LUS scores of the patients were recorded prospectively. The correlation between thorax CT score and LUS score was evaluated.Lung ultrasound score (LUSS):
LUS was performed by an intensive care specialist with experience in this field using a 2- to 5-MHz transducer (Esaote MyLabSeven, Getz Healthcare Malaysia). The transducer was covered with a probe cover, and the transducer and ultrasound device were cleaned with disinfectant wipes after each use. LUS examinations were performed at the bedside, in the supine position, and twelve-zone examinations were performed. Each hemithorax is separated into 6 quadrants: anterior, lateral, and posterior zones (separated by the anterior and posterior axillary lines) each divided in upper and lower portion (Figure 1). Each zone was scored according to the LUS pattern as follows: the presence of lung sliding with A-lines or fewer than two isolated B-lines, scored 0; when multiple well-defined B-lines presented, scored 1; the presence of multiple coalescent B-lines, scored 2; and when presented with a tissue pattern characterized by dynamic air bronchograms (lung consolidation), scored 3. The worst ultrasound pattern observed in each zone was recorded and used to calculate the sum of the scores (total score = 36).
CT Technique and Image Interpretation The thorax CT scans in the study were obtained using the low dose protocol of our hospital with a 128-slice multi-detector CT scanner (Optima; General Electric Healthcare, Wisconsin, USA). All CT scans were performed during a single breath-hold without contrast administration.
As in the ultrasound evaluation, each lung was divided into anterior, lateral and posterior quadrants based on the anterior and posterior axillary lines, and then each quadrant was divided into upper and lower sections. Each quadrant was scored between 0-3. It was scored 0 when there was no parenchymal involvement, 1score when the parenchymal involvement rate was between 0 and 33%, 2 score when it was between 33% and 66%, and 3score when it was above 66%.
- Conditions
- COVID-19
- Being tested
- severity of lung involvement with COVID-19.
- Keywords
- COVID-19 Pneumonia, Critical Care, Lung ultrasound, Computed tomography
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
severity of lung involvement with COVID-19.Other
transthoracic lung ultrasound and throcic CT
| Study group | Role | What they receive |
|---|---|---|
| Survivors group | Experimental | Lung ultrasound score and computed tomography score were evaluated in the surviving group Receives: Other: severity of lung involvement with COVID-19. |
| Non survivors group | Experimental | Lung ultrasound score and computed tomography score were evaluated in the non surviving group Receives: Other: severity of lung involvement with COVID-19. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The evaluation of the correlation between the baseline LUS score and mortality rate of patients with severe COVID-19 pneumonia who were followed up in the intensive care unit
LUS score
Measured: 2 month
Secondary outcomes (1)
The evaluation of the correlation between the baseline CT score and mortality rate of patients with severe COVID-19 pneumonia who were followed up in the intensive care unit
CT skore
Measured: 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2020
- Study start5 Jun 2020
- Primary completion5 Aug 2020
- Study completion5 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ayşe Vahapoglu, Gaziosmanpasa Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04577235
- Sponsor's protocol ID
- AyşeV
- Status last verified
- Oct 2020
- First submitted
- 29 Sep 2020
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Correlation Between Thoracic Ultrasound and Thorax Computed Tomography Scores of Patients With Severe COVID 19 Pneumonia in Intensive Care.
- ClinicalTrials.gov ID
- NCT04577235
- Acronym / sponsor ID
- AyşeV
- Conditions
- COVID-19
- Keywords
- COVID-19 Pneumonia, Critical Care, Lung ultrasound, Computed tomography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 5 Jun 2020 (actual)
- Primary completion
- 5 Aug 2020 (actual)
- Study completion
- 5 Sep 2020 (actual)
- First posted
- 6 Oct 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.
Coronavirus Disease 19 (COVID-19) pandemic has become a global health problem in a short time due to high infection rate and increasing mortality. Since it is not possible to perform thorax computed tomography (CT) and transfer of patients with COVID-19 pneumonia who are followed up in intensive care, diagnosis and follow-up by lung ultrasound (LUS) is a great advantage nowadays.The investigators aimed to evaluate the correlation between thoracic CT score and LUS score and to determine its relationship with mortality.
Patients who were admitted to intensive care with the diagnosis of COVID-19 pneumonia, who had an initial thorax CT examination and who underwent LUS during admission to the intensive care unit were included in the study. The demographic characteristics, clinical parameters, prognosis, thorax CT and LUS scores of the patients were recorded prospectively. The characteristics of the survived patients and the patients who died were compared.
Detailed description
Thorax CT scoring was performed by an experienced radiologist, while LUS scoring was performed an experienced anaesthesia and reanimation specialist. The demographic characteristics, clinical parameters, prognosis, thorax CT and LUS scores of the patients were recorded prospectively. The correlation between thorax CT score and LUS score was evaluated.Lung ultrasound score (LUSS):
LUS was performed by an intensive care specialist with experience in this field using a 2- to 5-MHz transducer (Esaote MyLabSeven, Getz Healthcare Malaysia). The transducer was covered with a probe cover, and the transducer and ultrasound device were cleaned with disinfectant wipes after each use. LUS examinations were performed at the bedside, in the supine position, and twelve-zone examinations were performed. Each hemithorax is separated into 6 quadrants: anterior, lateral, and posterior zones (separated by the anterior and posterior axillary lines) each divided in upper and lower portion (Figure 1). Each zone was scored according to the LUS pattern as follows: the presence of lung sliding with A-lines or fewer than two isolated B-lines, scored 0; when multiple well-defined B-lines presented, scored 1; the presence of multiple coalescent B-lines, scored 2; and when presented with a tissue pattern characterized by dynamic air bronchograms (lung consolidation), scored 3. The worst ultrasound pattern observed in each zone was recorded and used to calculate the sum of the scores (total score = 36).
CT Technique and Image Interpretation The thorax CT scans in the study were obtained using the low dose protocol of our hospital with a 128-slice multi-detector CT scanner (Optima; General Electric Healthcare, Wisconsin, USA). All CT scans were performed during a single breath-hold without contrast administration.
As in the ultrasound evaluation, each lung was divided into anterior, lateral and posterior quadrants based on the anterior and posterior axillary lines, and then each quadrant was divided into upper and lower sections. Each quadrant was scored between 0-3. It was scored 0 when there was no parenchymal involvement, 1score when the parenchymal involvement rate was between 0 and 33%, 2 score when it was between 33% and 66%, and 3score when it was above 66%.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Survivors group | Experimental | Other: severity of lung involvement with COVID-19.Lung ultrasound score and computed tomography score were evaluated in the surviving group |
| Non survivors group | Experimental | Other: severity of lung involvement with COVID-19.Lung ultrasound score and computed tomography score were evaluated in the non surviving group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Over 18 years of age
Key exclusion criteria (2 listed)
- Under 18 years of age
- Previous lung resection
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 |
|---|---|---|
| severity of lung involvement with COVID-19.transthoracic lung ultrasound and throcic CT | Other | Non survivors group, Survivors group |
Primary outcome
The evaluation of the correlation between the baseline LUS score and mortality rate of patients with severe COVID-19 pneumonia who were followed up in the intensive care unit
Time frame: 2 month
LUS score
1 secondary outcome
The evaluation of the correlation between the baseline CT score and mortality rate of patients with severe COVID-19 pneumonia who were followed up in the intensive care unit
Time frame: 2 month
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 6 Oct 2020.
- Individual participant dataSharing planned: No
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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?
A study testing severity of lung involvement with COVID-19. in people with COVID-19, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
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 2 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 6 Oct 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 Turkey (Türkiye). 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?
The evaluation of the correlation between the baseline LUS score and mortality rate of patients with severe COVID-19 pneumonia who were followed up in the intensive care unit (time frame: 2 month). 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 6 Oct 2020.