- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07702422
The Accuracy of Combined Parasternal Intercostal Muscle Thickening Fraction and Diaphragmatic Excursion in Predicting Failure of Libration From Mechanical Ventilation
The Accuracy of Combined Parasternal Intercostal Muscle Thickening Fraction and Diaphragmatic Excursion in Predicting Failure of Libration From Mechanical Ventilation: A Prospective Cohort Study.
Approximately 20% of patients in the intensive care unit (ICU) requiring mechanical ventilation (MV) experience difficulty and prolonged weaning. Early spontaneous breathing trials (SBT) and timely extubation are essential to avoid complications such as diaphragmatic dysfunction, ventilator-associated pneumonia, and airway trauma.
Mechanical ventilation is a vital supportive therapy in critical care. However, both delayed weaning and premature discontinuation are associated with poor outcomes and prolonged ICU stay. Prolonged MV may lead to complications including respiratory muscle dysfunction, ventilator-associated lung injury, and increased healthcare costs, emphasizing the importance of optimal timing of weaning.
Ultrasonography (US) has emerged as a rapid, non-invasive bedside tool for real-time assessment of respiratory muscle function. It allows evaluation of muscle thickness and contractility, aiding in the detection of diaphragmatic dysfunction.
In cases of diaphragmatic impairment, accessory respiratory muscles, particularly the parasternal intercostal muscles, play a compensatory role. Measurement of parasternal intercostal muscle thickness fraction (PICTF%) has been proposed as a predictor of weaning failure.
Additionally, composite indices such as the rapid shallow breathing index (RSBI) and compliance, rate, oxygenation, and pressure (CROP) index are widely used to assess weaning readiness. A recently proposed composite index combining PICTF (>9%) and diaphragmatic excursion (<15 mm) demonstrated high predictive value for failure of non-invasive ventilation.
Therefore, the present study aims to evaluate the effectiveness of this novel composite index in predicting weaning failure in mechanically ventilated patients.
Aperçu de l'étude
Statut
Les conditions
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
- All the patients with difficulty in obtaining an appropriate ultrasound window (diaphragmatic paralysis/injury, ascites, thoracotomy, pneumothorax, pleural effusion, flail chest, and rib fractures).
- Neuromuscular diseases.
- Severe head injury.
- Pregnant and lactating women.
La description
Inclusion Criteria:
- Age ≥ 18 years old.
- Both sexes.
- Patients who have been mechanically ventilated for more than 48 h.
Exclusion Criteria:
- All the patients with difficulty in obtaining an appropriate ultrasound window (diaphragmatic paralysis/injury, ascites, thoracotomy, pneumothorax, pleural effusion, flail chest, and rib fractures).
- Neuromuscular diseases.
- Severe head injury.
- Pregnant and lactating women.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Ability of a combined PICTF% and diaphragmatic excursion to predict weaning failure .
Délai: 5minutes after spontaneous breathing trail and after 5minutes of spontaneous breathing trail
|
Parasternal intercostal muscle thickening fraction (%) measured by ultrasound at 5 minutes after the start of the spontaneous breathing trial to evaluate its ability to predict weaning failure and diaphragmatic excursion
|
5minutes after spontaneous breathing trail and after 5minutes of spontaneous breathing trail
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
• Difference between PICTF % at 5 and 60 min OF SBT. • RSBI at 5and 60 min of SBT. • Correlation between PICTF% and RSBI Diaphragmatic excursion
Délai: at 5 mintues of spontanous breathing trail and at 60 minutes
|
at 5 mintues of spontanous breathing trail and at 60 minutes
|
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
Autres numéros d'identification d'étude
- md-461-2024
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .