Blunt Chest TraumaNCT07807566
Combined Lung and Diaphragmatic Ultrasound to Predict Respiratory Failure in Blunt Chest Trauma
An observational study of Blunt Chest Trauma and Respiratory Failure, run by Assiut University.
Trial summary
Blunt chest trauma is a leading cause of emergency hospital visits and can result in severe breathing complications such as hypoxemic respiratory failure. While computed tomography (CT) scans provide detailed imaging of the chest, their routine use is limited by radiation exposure, high cost, and the inability to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blunt Chest Trauma, Respiratory Failure, Thoracic Injuries
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: Adult patients presenting to the emergency room of the Trauma Unit at Assiut University Hospitals within 24 hours of sustaining isolated blunt chest trauma.
Who may be able to join
- Age 18 years or older
- Presentation to the trauma unit within 24 hours of injury
- Diagnosed with isolated blunt chest trauma
- Willingness to participate with written informed consent provided by the patient or legally authorized representative
Who cannot join
- Penetrating chest trauma
- Immediate endotracheal intubation before baseline ultrasound assessment
- Massive hemothorax or tension pneumothorax requiring immediate emergency intervention prior to ultrasound evaluation
- Inadequate ultrasound acoustic window due to extensive subcutaneous emphysema or severe obesity
- Known preexisting chronic pulmonary disease (e.g., chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, bronchial asthma)
- Known preexisting cardiac disease (e.g., ischemic heart disease, rheumatic heart disease)
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- Known neuromuscular disorders affecting respiratory muscles
- Previous thoracic surgery affecting diaphragmatic excursion or documented diaphragmatic paralysis
- Pregnancy
- Refusal to provide informed consent or withdrawal from the study
About this study
Official title: The Additive Value of Diaphragmatic Ultrasound to Lung Ultrasound for Early Prediction of Hypoxemic Respiratory Failure Following Isolated Blunt Chest Trauma: A Prospective Cohort Study
Blunt chest trauma is a leading cause of emergency hospital visits and can result in severe breathing complications such as hypoxemic respiratory failure. While computed tomography (CT) scans provide detailed imaging of the chest, their routine use is limited by radiation exposure, high cost, and the inability to perform frequent bedside monitoring. Bedside lung ultrasound (LUS) is commonly used to detect structural injuries like lung contusions or collapsed lungs, but it cannot assess how well the breathing muscles are working. Because acute respiratory failure after chest trauma involves both lung tissue damage and impaired breathing muscle mechanics, combining lung ultrasound with diaphragmatic ultrasound may improve early risk assessment.
The primary purpose of this prospective cohort study is to determine whether combining point-of-care lung ultrasound with diaphragmatic ultrasound provides better early prediction of hypoxemic respiratory failure than lung ultrasound alone in adult patients with isolated blunt chest trauma.
Read more
Participants will undergo bedside lung ultrasound, diaphragmatic ultrasound, and arterial blood gas testing at four standardized time points: upon hospital admission (baseline), and at 6, 12, and 24 hours after admission. The lung ultrasound examination assesses the degree of lung tissue injury using a standardized 12-zone Lung Ultrasound Score (LUS). Diaphragmatic ultrasound measures muscle movement (diaphragmatic excursion) and contraction strength (diaphragm thickening fraction). Arterial blood gas results will be used to track oxygenation via the PaO2/FiO2 ratio, with a ratio of 300 mmHg or lower defining hypoxemic respiratory failure. All participants will also receive a standard-of-care chest CT scan as a reference comparison.
The study aims to evaluate whether this non-invasive, radiation-free bedside approach helps emergency physicians identify high-risk patients earlier, guiding timely respiratory support and intensive care triage while minimizing the need for repeated CT scans.
- Keywords
- Lung ultrasound, Diaphragmatic ultrasound, Diaphragmatic excursion, Diaphragm thickening fraction, Point-of-care ultrasound, POCUS, Lung Ultrasound Score, Pulmonary contusion
- Medical subject headings
- Respiratory Insufficiency, Thoracic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Isolated Blunt Chest Trauma Patients | Adult patients presenting within 24 hours of isolated blunt chest trauma. All participants undergo serial bedside point-of-care lung ultrasound (12-zone protocol to calculate total LUS) and diaphragmatic ultrasound (measuring diaphragmatic excursion [DE] and diaphragm thickening fraction [DTF]), paired with arterial blood gas analysis to calculate the PaO₂/FiO₂ ratio at four predefined time points: admission (baseline), 6 hours, 12 hours, and 24 hours post-admission. Patients also undergo baseline chest CT imaging as a standard reference. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of Arterial Oxygen Partial Pressure to Fractional Inspired Oxygen (PaO2/FiO2)
PaO2/FiO2 ratio will be calculated using arterial blood gas (ABG) analysis. Hypoxemic respiratory failure is defined as a PaO2/FiO2 ratio of 300 mmHg or less. Values will be measured in mmHg.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blunt Chest TraumaStudies 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
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Ahmed Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07807566
- Sponsor's protocol ID
- Lung & Diaphragm US in Trauma
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Additive Value of Diaphragmatic Ultrasound to Lung Ultrasound for Early Prediction of Hypoxemic Respiratory Failure Following Isolated Blunt Chest Trauma: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07807566
- Acronym / sponsor ID
- Lung & Diaphragm US in Trauma
- Keywords
- Lung ultrasound, Diaphragmatic ultrasound, Diaphragmatic excursion, Diaphragm thickening fraction, Point-of-care ultrasound, POCUS, Lung Ultrasound Score, Pulmonary contusion
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 8 Sep 2026 (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.
Blunt chest trauma is a leading cause of emergency hospital visits and can result in severe breathing complications such as hypoxemic respiratory failure. While computed tomography (CT) scans provide detailed imaging of the chest, their routine use is limited by radiation exposure, high cost, and the inability to perform frequent bedside monitoring. Bedside lung ultrasound (LUS) is commonly used to detect structural injuries like lung contusions or collapsed lungs, but it cannot assess how well the breathing muscles are working. Because acute respiratory failure after chest trauma involves both lung tissue damage and impaired breathing muscle mechanics, combining lung ultrasound with diaphragmatic ultrasound may improve early risk assessment.
The primary purpose of this prospective cohort study is to determine whether combining point-of-care lung ultrasound with diaphragmatic ultrasound provides better early prediction of hypoxemic respiratory failure than lung ultrasound alone in adult patients with isolated blunt chest trauma.
Participants will undergo bedside lung ultrasound, diaphragmatic ultrasound, and arterial blood gas testing at four standardized time points: upon hospital admission (baseline), and at 6, 12, and 24 hours after admission. The lung ultrasound examination assesses the degree of lung tissue injury using a standardized 12-zone Lung Ultrasound Score (LUS). Diaphragmatic ultrasound measures muscle movement (diaphragmatic excursion) and contraction strength (diaphragm thickening fraction). Arterial blood gas results will be used to track oxygenation via the PaO2/FiO2 ratio, with a ratio of 300 mmHg or lower defining hypoxemic respiratory failure. All participants will also receive a standard-of-care chest CT scan as a reference comparison.
The study aims to evaluate whether this non-invasive, radiation-free bedside approach helps emergency physicians identify high-risk patients earlier, guiding timely respiratory support and intensive care triage while minimizing the need for repeated CT scans.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Isolated Blunt Chest Trauma Patients | – | –Adult patients presenting within 24 hours of isolated blunt chest trauma. All participants undergo serial bedside point-of-care lung ultrasound (12-zone protocol to calculate total LUS) and diaphragmatic ultrasound (measuring diaphragmatic excursion [DE] and diaphragm thickening fraction [DTF]), paired with arterial blood gas analysis to calculate the PaO₂/FiO₂ ratio at four predefined time points: admission (baseline), 6 hours, 12 hours, and 24 hours post-admission. Patients also undergo baseline chest CT imaging as a standard reference. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients presenting to the emergency room of the Trauma Unit at Assiut University Hospitals within 24 hours of sustaining isolated blunt chest trauma.
Key inclusion criteria (4 listed)
- Age 18 years or older
- Presentation to the trauma unit within 24 hours of injury
- Diagnosed with isolated blunt chest trauma
- Willingness to participate with written informed consent provided by the patient or legally authorized representative
Key exclusion criteria (10 listed)
- Penetrating chest trauma
- Immediate endotracheal intubation before baseline ultrasound assessment
- Massive hemothorax or tension pneumothorax requiring immediate emergency intervention prior to ultrasound evaluation
- Inadequate ultrasound acoustic window due to extensive subcutaneous emphysema or severe obesity
- Known preexisting chronic pulmonary disease (e.g., chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, bronchial asthma)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ratio of Arterial Oxygen Partial Pressure to Fractional Inspired Oxygen (PaO2/FiO2)
Time frame: 1 day
PaO2/FiO2 ratio will be calculated using arterial blood gas (ABG) analysis. Hypoxemic respiratory failure is defined as a PaO2/FiO2 ratio of 300 mmHg or less. Values will be measured in mmHg.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Blunt Chest Trauma and Respiratory Failure, run by Assiut University.
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 10 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: opening soon, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Ratio of Arterial Oxygen Partial Pressure to Fractional Inspired Oxygen (PaO2/FiO2) (time frame: 1 day). 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 8 Sep 2026.