- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05636631
Chest U/S in Differentiating Lung Congestion & Pneumonia in Adult Critically-ill Patients and Its Prognostic Impact
The Role of Chest Ultrasound in Differentiating Lung Congestion and Pneumonia in Adult Critically-ill Patients and Its Prognostic Impact
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Lung ultrasound (LUS) is used at the bedside in emergency and critical care settings. It is a rapid and low-cost approach that can direct patient care without the use of harmful radiation. The success of this technique depends on its simplicity to discover the sonographic signs which indicate certain lung pathology. These signs include a hyperechoic and sliding line, moving forward and back with ventilation seen 0.5 cm below the rib line and is called the pleural line. The A-profile associates anterior lung sliding with A lines. A lines are horizontal repetition artifacts of the pleural line. The B-profile associates anterior lung sliding with B lines. B lines appear as shining vertical lines arising from the pleural line and reach the edge of the screen.
Several pathological etiologies can fill the alveolar spaces, with fluid (heart failure), pus (pneumonia which is the commonest), blood (pulmonary hemorrhage), and cells (lung cancer).
Other causes of lung consolidation may include atelectasis, pulmonary edema, infarction, and lung cancer. Chest imaging with CT is regarded as the gold standard modality allowing for the diagnosis of pneumonia in earlier stage and with higher sensitivity and specificity. On the contrary, cardiogenic pulmonary edema (CPE) is defined as alveolar transudation caused by elevated pulmonary capillary hydrostatic pressure secondary to increased pulmonary venous pressure with low-protein content in the interstitial tissue of lung as a result of cardiac dysfunction
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Nardin Aymn, resident
- Phone Number: 01285151220
- Email: Nardeen.14223960@med.aun.edu.eg
Study Contact Backup
- Name: Alaa Ahmed, lecturer
- Email: alaa_omar11@aun.edu.eg
Study Locations
-
-
Asyut
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Assiut, Asyut, Egypt, 71511
- Recruiting
- Nardin Aymn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult (above 18 years old)
- Both genders
- Patient with symptoms suggestive of pneumonia
- Patient with symptoms suggestive of acute congestive heart failure
- admitted to Critical care unit
Exclusion Criteria:
- Patients with Renal induced lung congestion
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients with Pneumonia (1)
Patients presented with symptoms suggestive of pneumonia as fever, tachypnea, cough with sputum.
These patients will receive IV fluids & antibiotics with follow up of sepsis parameters
|
chest ultrasound as a non invasive, low cost & bedside device for differentiation & follow up of lung congestion & pneumonia
|
Patients with decongestive heart failure (2)
Patients presented with symptoms suggestive of acute congestive heart failure as dyspnea, orthopnea, bilateral lower limb edema.
These patients will receive anti-failure treatment as diuretics, ACE inhibitors & Beta blockers with follow up of resolving signs of decompensated heart failure
|
chest ultrasound as a non invasive, low cost & bedside device for differentiation & follow up of lung congestion & pneumonia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnostic tool
Time Frame: Baseline
|
Diagnosis of pneumonia vs lung congestion by using chest ultrasound examination viewing A-lines, B-lines, pleural effusion presence & its initial amount .
|
Baseline
|
Follow up after initiation of treatment
Time Frame: Baseline ( day 3 of hospital admission)
|
Follow up of findings of chest U.S on day 1 after initiating therapy using same parameters ( A-lines, B-lines, pleural effusion) on day 3 of hospital admission
|
Baseline ( day 3 of hospital admission)
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Follow up before assessing final outcome
Time Frame: Baseline ( day 7 of hospital admission)
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Follow up of findings of chest U.S on day 1 after initiating therapy using same parameters ( A-lines, B-lines, pleural effusion) on day 7 of hospital admission
|
Baseline ( day 7 of hospital admission)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
morbidity & mortality
Time Frame: baseline
|
if patient's symptoms improved or not If patient died or not
|
baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Mahmoud Ashry, Professor, Professor Faculty of Medicine, Assiut University
Publications and helpful links
General Publications
- Lichtenstein DA. BLUE-protocol and FALLS-protocol: two applications of lung ultrasound in the critically ill. Chest. 2015 Jun;147(6):1659-1670. doi: 10.1378/chest.14-1313.
- Volpicelli G, Cardinale L, Garofalo G, Veltri A. Usefulness of lung ultrasound in the bedside distinction between pulmonary edema and exacerbation of COPD. Emerg Radiol. 2008 May;15(3):145-51. doi: 10.1007/s10140-008-0701-x. Epub 2008 Jan 31.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- chest US for lung conditions
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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