- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Type d'étude
Inscription (Estimé)
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Ratio of Arterial Oxygen Partial Pressure to Fractional Inspired Oxygen (PaO2/FiO2)
Délai: 1 day
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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.
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1 day
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Lung & Diaphragm US in Trauma
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