UltrasonographyNCT04432051
The Use of Lung Ultrasonography in COVID-19 Patients
A study testing mechanical ventilator settings and position in people with Ultrasonography, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
In COVID-19 patients hospitalized in the intensive care unit due to respiratory failure, lung ultrasonography will be tried to be given an appropriate position that will effectively use lung capacity and its effect on oxygenation will be investigated. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ultrasonography
- What is being tested?
- mechanical ventilator settings and position
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 May 2020to 10 Aug 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients have been diagnosed with COVID 19
- Patients in the intensive care unit over the age of 18
Who cannot join
- Patients not diagnosed with COVID 19
- Patients with cardiac problems
- Patients with renal problems
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazoosmanpasa Education and Research Hospital
Istanbul
About this study
Official title: The Significance of Lung Ultrasonography in the Follow-up and Treatment of COVID-19 Patients With Respiratory Failure
In COVID-19 patients hospitalized in the intensive care unit due to respiratory failure, lung ultrasonography will be tried to be given an appropriate position that will effectively use lung capacity and its effect on oxygenation will be investigated.
Read the detailed description
In this study, the COVID-19 patients hospitalized in the intensive care unit due to respiratory failure will be evaluated. Participants will be divided into two groups as patients undergoing lung ultrasonography (Group Ultrasonography ) and those without lung ultrasonography (Group Control).
While performing lung ultrasonography, each hemithorax will be evaluated using anterior axillary line and posterior axillary line into anterior, lateral and posterior region, and each region will be divided into 6 quadrants, upper and lower. Each hemithorax will be scanned by the investigators, scored in 6 regions using a convex ultrasonography probe with the Lung Ultrasound Score (LUS score).
Participants in both groups will be evaluated by comparing arterial blood gas analyzes before examination (with/without ultrasonography), at the 2nd and 12th hours. Is there any change in arterial blood gas values such as PO2 and PCO2 at 0, 2 and 12 hours so that oxygenation and ventilation between Group Ultrasonograpy and Group Control will be evaluated?
- Conditions
- Ultrasonography
- Being tested
- mechanical ventilator settings and position
- Keywords
- lung ultrasonography, intensive care unit, position, COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mechanical ventilator settings and positionBehavioural
Mechanical ventilation settings and patient position will be re-evaluated
| Study group | Role | What they receive |
|---|---|---|
| GRUP Control | Placebo comparator | The daily respiratory system examination of COVID-19 patients who are hospitalized in the intensive care unit is performed and the necessary mechanical ventilation applications are performed by evaluating the arterial blood gas analysis. Receives: Behavioral: mechanical ventilator settings and position |
| GRUP Ultrasonography | Active comparator | The daily respiratory system examination of COVID-19 patients who are hospitalized in the intensive care unit is performed and the necessary mechanical ventilation applications are performed by evaluating the arterial blood gas analysis. However, the lung of the patient will be evaluated by ultrasound and the position to use the lung capacity most appropriately will be given. Receives: Behavioral: mechanical ventilator settings and position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PO2 values
Effect of positioning on ultrasound guidance on oxygenation assessed by changes between pO2 values.
Measured: 12 hours
Secondary outcomes (1)
Change in PCO2 values
Effect of positioning on ultrasound guidance on ventilation assessed by changes between pCO2 values.
Measured: 12 hours
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 start26 May 2020
- Primary completion8 Aug 2020
- Study completion10 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UltrasonographyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- patients will be divided into two groups, those with and without ultrasound.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04432051
- Sponsor's protocol ID
- Gaziosmanpasa
- Status last verified
- Aug 2020
- First submitted
- 11 Jun 2020
- Last updated
- 22 Dec 2022
- 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 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Significance of Lung Ultrasonography in the Follow-up and Treatment of COVID-19 Patients With Respiratory Failure
- ClinicalTrials.gov ID
- NCT04432051
- Acronym / sponsor ID
- Gaziosmanpasa
- Conditions
- Ultrasonography
- Keywords
- lung ultrasonography, intensive care unit, position, COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 26 May 2020 (actual)
- Primary completion
- 8 Aug 2020 (actual)
- Study completion
- 10 Aug 2020 (actual)
- 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.
In COVID-19 patients hospitalized in the intensive care unit due to respiratory failure, lung ultrasonography will be tried to be given an appropriate position that will effectively use lung capacity and its effect on oxygenation will be investigated.
Detailed description
In this study, the COVID-19 patients hospitalized in the intensive care unit due to respiratory failure will be evaluated. Participants will be divided into two groups as patients undergoing lung ultrasonography (Group Ultrasonography ) and those without lung ultrasonography (Group Control).
While performing lung ultrasonography, each hemithorax will be evaluated using anterior axillary line and posterior axillary line into anterior, lateral and posterior region, and each region will be divided into 6 quadrants, upper and lower. Each hemithorax will be scanned by the investigators, scored in 6 regions using a convex ultrasonography probe with the Lung Ultrasound Score (LUS score).
Participants in both groups will be evaluated by comparing arterial blood gas analyzes before examination (with/without ultrasonography), at the 2nd and 12th hours. Is there any change in arterial blood gas values such as PO2 and PCO2 at 0, 2 and 12 hours so that oxygenation and ventilation between Group Ultrasonograpy and Group Control will be evaluated?
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- patients will be divided into two groups, those with and without ultrasound.
| Arm | Type | Receives |
|---|---|---|
| GRUP Control | Placebo comparator | Behavioral: mechanical ventilator settings and positionThe daily respiratory system examination of COVID-19 patients who are hospitalized in the intensive care unit is performed and the necessary mechanical ventilation applications are performed by evaluating the arterial blood gas analysis. |
| GRUP Ultrasonography | Active comparator | Behavioral: mechanical ventilator settings and positionThe daily respiratory system examination of COVID-19 patients who are hospitalized in the intensive care unit is performed and the necessary mechanical ventilation applications are performed by evaluating the arterial blood gas analysis. However, the lung of the patient will be evaluated by ultrasound and the position to use the lung capacity most appropriately will be given. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients have been diagnosed with COVID 19
- Patients in the intensive care unit over the age of 18
Key exclusion criteria (3 listed)
- Patients not diagnosed with COVID 19
- Patients with cardiac problems
- Patients with renal problems
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 |
|---|---|---|
| mechanical ventilator settings and positionMechanical ventilation settings and patient position will be re-evaluated | Behavioural | GRUP Control, GRUP Ultrasonography |
Primary outcome
Change in PO2 values
Time frame: 12 hours
Effect of positioning on ultrasound guidance on oxygenation assessed by changes between pO2 values.
1 secondary outcome
Change in PCO2 values
Time frame: 12 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 Dec 2022.
- 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 mechanical ventilator settings and position in people with Ultrasonography, 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 2 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 Dec 2022. 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. Some participants in this study may receive a placebo. 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?
Change in PO2 values (time frame: 12 hours). 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 22 Dec 2022.