PneumoniaNCT05636631
Chest U/S in Differentiating Lung Congestion & Pneumonia in Adult Critically-ill Patients and Its Prognostic Impact
An observational study of Pneumonia and Pulmonary Edema, run by Assiut University at 1 site in Egypt.
Trial summary
This study aim will be to assess the effectiveness of chest ultrasound as a diagnostic and differentiating modality in cases of pneumonia and lung congestion . It also evaluates chests sonography effectiveness in follow-up of patients with pneumonia and lung congestion . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Pulmonary Edema
- What is being tested?
- Chest ultrasound
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2022to 31 Jul 2025
- Phase
- Observational
- 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
Study population: both genders adult (above age of 18 years) critically ill patients
Who may be able to join
- 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
Who cannot join
- Patients with Renal induced lung congestion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Chest Ultrasound in Differentiating Lung Congestion and Pneumonia in Adult Critically-ill Patients and Its Prognostic Impact
This study aim will be to assess the effectiveness of chest ultrasound as a diagnostic and differentiating modality in cases of pneumonia and lung congestion . It also evaluates chests sonography effectiveness in follow-up of patients with pneumonia and lung congestion .
Read the 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
- Conditions
- Pneumonia, Pulmonary Edema
- Being tested
- Chest ultrasound
- Medical subject headings
- Pneumonia, Pulmonary Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest ultrasoundDevice
chest ultrasound as a non invasive, low cost \& bedside device for differentiation \& follow up of lung congestion \& pneumonia
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Chest ultrasound | |
| 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 Receives: Device: Chest ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic tool
Diagnosis of pneumonia vs lung congestion by using chest ultrasound examination viewing A-lines, B-lines, pleural effusion presence \& its initial amount .
Measured: Baseline
Follow up after initiation of treatment
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
Measured: Baseline ( day 3 of hospital admission)
Follow up before assessing final outcome
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
Measured: Baseline ( day 7 of hospital admission)
Secondary outcomes (1)
morbidity & mortality
if patient's symptoms improved or not If patient died or not
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start1 Nov 2022
- Primary completion30 Nov 2024
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nardin Aymn Boshra, Assiut University
- Investigators
- Mahmoud Ashry, Professor, Study director, Professor Faculty of Medicine, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05636631
- Sponsor's protocol ID
- chest US for lung conditions
- Status last verified
- Dec 2022
- First submitted
- 4 Nov 2022
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 18236088Lichtenstein 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.
PubMed 26033127
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Chest Ultrasound in Differentiating Lung Congestion and Pneumonia in Adult Critically-ill Patients and Its Prognostic Impact
- ClinicalTrials.gov ID
- NCT05636631
- Acronym / sponsor ID
- chest US for lung conditions
- Conditions
- Pneumonia, Pulmonary Edema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 5 Dec 2022 (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.
This study aim will be to assess the effectiveness of chest ultrasound as a diagnostic and differentiating modality in cases of pneumonia and lung congestion . It also evaluates chests sonography effectiveness in follow-up of patients with pneumonia and lung congestion .
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Pneumonia (1) | – | Device: Chest ultrasoundPatients 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 |
| Patients with decongestive heart failure (2) | – | Device: Chest ultrasoundPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- both genders adult (above age of 18 years) critically ill patients
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Patients with Renal induced lung congestion
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 |
|---|---|---|
| Chest ultrasoundchest ultrasound as a non invasive, low cost \& bedside device for differentiation \& follow up of lung congestion \& pneumonia | Device | Patients with Pneumonia (1), Patients with decongestive heart failure (2) |
Primary outcome
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 .
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
Follow up before assessing final outcome
Time frame: Baseline ( day 7 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 7 of hospital admission
1 secondary outcome
morbidity & mortality
Time frame: baseline
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 29 Oct 2026.
- Background: PubMed 18236088Volpicelli 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.
- Background: PubMed 26033127Lichtenstein 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.
- Individual participant dataSharing planned: Undecided
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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.
Mahmoud Ashry, Professor study director
Professor Faculty of Medicine, Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia and Pulmonary Edema, run by Assiut University at 1 site in Egypt.
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 5 inclusion and 1 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 29 Oct 2026. 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 Egypt. 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?
Diagnostic tool (time frame: Baseline). The study lists 3 primary outcomes in all. 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 NCT05636631, which also lists 2 linked publications.
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 29 Oct 2026.