- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04432051
The Use of Lung Ultrasonography in COVID-19 Patients
The Significance of Lung Ultrasonography in the Follow-up and Treatment of COVID-19 Patients With Respiratory Failure
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey
- Gazoosmanpasa Education and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients have been diagnosed with COVID 19
- Patients in the intensive care unit over the age of 18
Exclusion Criteria:
- Patients not diagnosed with COVID 19
- Patients with cardiac problems
- Patients with renal problems
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: GRUP Control
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.
|
Mechanical ventilation settings and patient position will be re-evaluated
|
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Active Comparator: GRUP Ultrasonography
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.
|
Mechanical ventilation settings and patient position will be re-evaluated
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in PO2 values
Time Frame: 12 hours
|
Effect of positioning on ultrasound guidance on oxygenation assessed by changes between pO2 values.
|
12 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in PCO2 values
Time Frame: 12 hours
|
Effect of positioning on ultrasound guidance on ventilation assessed by changes between pCO2 values.
|
12 hours
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Gaziosmanpasa
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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