- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT07807566
Combined Lung and Diaphragmatic Ultrasound to Predict Respiratory Failure in Blunt Chest Trauma
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.
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.
Studie Overzicht
Toestand
Studietype
Inschrijving (Geschat)
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
- 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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
|---|
|
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Ratio of Arterial Oxygen Partial Pressure to Fractional Inspired Oxygen (PaO2/FiO2)
Tijdsspanne: 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.
|
1 day
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Lung & Diaphragm US in Trauma
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .