Lung UltrasoundNCT04719234
Lung Ultrasonography in COVID-19 Pneumonia
A study testing lung ultrasonography in people with Lung Ultrasound and Pneumonia, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Lung ultrasonography has been used for diagnosis and treatment in many departments including intensive care before the pandemic. The gold standard method for the diagnosis of pneumonia is still chest tomography. Ultrasonography, which has advantages over tomography, has also been tried to be used in covid 19 pneumonia. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Lung Ultrasound, Pneumonia, Covid19
- What is being tested?
- lung ultrasonography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2020to 1 Dec 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 and 85 years old
- Hospitalized in intensive care unit
- PCR tested
- Thoracic CT applied
Who cannot join
- Previous lung and thoracic wall surgery
- Anatomically with thoracic wall disorder
- Patients who did not consent to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital
Bursa
About this study
Official title: Comparison of Lung Ultrasonography Findings With Chest Computerized Tomography Results in Corona virüs (COVID-19) Pneumonia
Lung ultrasonography has been used for diagnosis and treatment in many departments including intensive care before the pandemic. The gold standard method for the diagnosis of pneumonia is still chest tomography. Ultrasonography, which has advantages over tomography, has also been tried to be used in covid 19 pneumonia.
Read the detailed description
In this study, it was aimed to investigate the efficiency of lung ultrasonography in diagnosis of covid 19 pneumonia.
- Conditions
- Lung Ultrasound, Pneumonia, Covid19
- Being tested
- lung ultrasonography
- Medical subject headings
- Pneumonia, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lung ultrasonographyDevice
Application of 12 zone lung ultrasonography protocol using the konvex ultrasound probe (2-6 MHz)
| Study group | Role | What they receive |
|---|---|---|
| lung ultrasound | Other | lung ultrasonography protocol will be applied. Receives: Device: lung ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between Thoracic CT imaging results and LUS results
Lung ultrasonography will be performed within 6 hours of the Thoracic CT.
Measured: 6 hours
Secondary outcomes (1)
Characteristics of lesions
İdentifying the characteristics of the abnormal findings detected in Thoracic CT and LUS
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start15 Jun 2020
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung UltrasoundStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Korgün Ökmen, Bursa Yuksek Ihtisas Training and Research Hospital
- Investigators
- Korgün Ökmen, Assoc. PhD., Principal investigator, Sağlık Bilimleri Üniversitesi Bursa Yüksek İhtisas Eğitim Ve Araştırma HastanesiDurdu Kahraman Yıldız, M.D, Study chair, Sağlık Bilimleri Üniversitesi Bursa Yüksek İhtisas Eğitim Ve Araştırma HastanesiEmel Tatar Soyaslan, M.D, Study chair, Sağlık Bilimleri Üniversitesi Bursa Yüksek İhtisas Eğitim Ve Araştırma Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04719234
- Sponsor's protocol ID
- 2011-KAEK-25 2020/5-21
- Status last verified
- Jan 2021
- First submitted
- 20 Jan 2021
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Okmen K, Yildiz DK, Soyaslan E. Comparison of lung ultrasonography findings with chest computed tomography results in coronavirus (COVID-19) pneumonia. J Med Ultrason (2001). 2021 Apr;48(2):245-252. doi: 10.1007/s10396-021-01081-7. Epub 2021 Feb 26.
PubMed 33638057
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Lung Ultrasonography Findings With Chest Computerized Tomography Results in Corona virüs (COVID-19) Pneumonia
- ClinicalTrials.gov ID
- NCT04719234
- Acronym / sponsor ID
- 2011-KAEK-25 2020/5-21
- Conditions
- Lung Ultrasound, Pneumonia, Covid19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 22 Jan 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.
Lung ultrasonography has been used for diagnosis and treatment in many departments including intensive care before the pandemic. The gold standard method for the diagnosis of pneumonia is still chest tomography. Ultrasonography, which has advantages over tomography, has also been tried to be used in covid 19 pneumonia.
Detailed description
In this study, it was aimed to investigate the efficiency of lung ultrasonography in diagnosis of covid 19 pneumonia.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lung ultrasound | Other | Device: lung ultrasonographylung ultrasonography protocol will be applied. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 and 85 years old
- Hospitalized in intensive care unit
- PCR tested
- Thoracic CT applied
Key exclusion criteria (3 listed)
- Previous lung and thoracic wall surgery
- Anatomically with thoracic wall disorder
- Patients who did not consent to participate in the study
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 |
|---|---|---|
| lung ultrasonographyApplication of 12 zone lung ultrasonography protocol using the konvex ultrasound probe (2-6 MHz) | Device | lung ultrasound |
Primary outcome
Relationship between Thoracic CT imaging results and LUS results
Time frame: 6 hours
Lung ultrasonography will be performed within 6 hours of the Thoracic CT.
1 secondary outcome
Characteristics of lesions
Time frame: 6 hours
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 22 Jan 2021.
- Derived from this study: PubMed 33638057Okmen K, Yildiz DK, Soyaslan E. Comparison of lung ultrasonography findings with chest computed tomography results in coronavirus (COVID-19) pneumonia. J Med Ultrason (2001). 2021 Apr;48(2):245-252. doi: 10.1007/s10396-021-01081-7. Epub 2021 Feb 26.
- 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.
Korgün Ökmen, Assoc. PhD. principal investigator
Sağlık Bilimleri Üniversitesi Bursa Yüksek İhtisas Eğitim Ve Araştırma Hastanesi
Durdu Kahraman Yıldız, M.D study chair
Sağlık Bilimleri Üniversitesi Bursa Yüksek İhtisas Eğitim Ve Araştırma Hastanesi
Emel Tatar Soyaslan, M.D study chair
Sağlık Bilimleri Üniversitesi Bursa Yüksek İhtisas Eğitim Ve Araştırma Hastanesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lung ultrasonography in people with Lung Ultrasound and Pneumonia, run by Bursa Yuksek Ihtisas Training and Research 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 4 inclusion and 3 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 22 Jan 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 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?
Relationship between Thoracic CT imaging results and LUS results (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04719234, which also lists 1 linked publication.
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 22 Jan 2021.