- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03094299
Diaphragm Ultrasound in Weaning From Mechanical Ventilation
The Efficacy of Ultrasound Assessment of Diaphragmatic Function in Guiding Weaning From Mechanical Ventilation in Critically Ill Patients With Abdominal Sepsis
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Difficult weaning from mechanical ventilation (MV) is a common problem in critically ill patients. Many parameters have been developed to aid weaning from MV such as P/F ratio (PO2/FiO2) and rapid shallow breathing index (respiratory rate/tidal volume); however, sensitivity and specificity for most variables are still variable in literature.
Diaphragmatic dysfunction is a common cause of weaning failure (2) however most of the traditional methods used for evaluation of diaphragmatic function (fluoroscopy, trans-diaphragmatic pressure measurement) are invasive and not available.
Ultrasound assessment of diaphragmatic function has been developed recently providing an easy and safe method for evaluation of diaphragmatic excursion and thickening. In this study we will evaluate the ability of the diaphragmatic function to predict weaning success in patients with abdominal sepsis.
After weaning, patients will be divided into two groups; group of successful weaning (group S) and group with failed weaning (group F) both groups will be compared as regards all clinical, laboratory, and ultrasonographic parameters recorded before weaning, further analysis will be done for patients with repeated trials of weaning (more than one trial or more than one week MV) and those with simple weaning (first time for weaning).
A 7-10 Mega Hertz linear ultrasound probe (Mindray machine) set to B mode, the diaphragm will be visualized by placing the transducer perpendicular to the chest wall, in the eighth or ninth intercostal space, between the anterior axillary and the midaxillary lines, to observe the zone of apposition of the muscle 0.5 to 2 cm below the costophrenic sinus.
The diaphragm thickness will be measured from the middle of the pleural line to the middle of the peritoneal line. Then, the diaphragmatic fraction thickening (DTF) will be calculated as percentage Diaphragmatic movement will be measured in all patients with a 3.5 Mega Hertz US probe placed over one of the lower intercostal spaces in the right anterior axillary line for the right diaphragm and the left midaxillary line for the left diaphragm.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
-
-
-
Cairo, Egypte
- Cairo University
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Critically ill patients with abdominal sepsis with history of MV for more than 48 hours
Exclusion Criteria:
- Age < 18 years and surgical dressings over the right lower rib cage which would preclude ultrasound examination will be excluded. Also, patients with chest trauma, thoracotomy, diaphragmatic paralysis, diaphragmatic dysfunction, diaphragmatic injury, diaphragmatic surgery and patients with neuromuscular diseases
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 |
|---|---|---|
|
Diaphragmatic thickening fraction
Délai: five minutes before spontaneous breathing trial
|
(calculated as maximum thickness - minimum thickness / maximum thickness)
|
five minutes before spontaneous breathing trial
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Diaphragmatic excursion
Délai: five minutes before spontaneous breathing trial and five minutes before patient extubation
|
(measured in millimeters)
|
five minutes before spontaneous breathing trial and five minutes before patient extubation
|
|
Rapid shallow breathing index (RSBI)
Délai: five minutes before spontaneous breathing trial
|
Respiratory rate/tidal volume in litres
|
five minutes before spontaneous breathing trial
|
|
Arterial blood gases
Délai: five minutes before spontaneous breathing trial and five minutes before patient extubation
|
Partial oxygen pressure and Partial carbon dioxide pressure
|
five minutes before spontaneous breathing trial and five minutes before patient extubation
|
|
Number of weaning trials
Délai: during the last 7 days
|
number of weaning trials before this trial
|
during the last 7 days
|
|
Heart rate
Délai: five minutes before spontaneous breathing trial and five minutes before patient extubation
|
the patient heart rate measured as beat.minute
|
five minutes before spontaneous breathing trial and five minutes before patient extubation
|
|
Arterial blood pressure
Délai: five minutes before spontaneous breathing trial and five minutes before patient extubation
|
systolic and diastolic blood pressure measured in mmHg
|
five minutes before spontaneous breathing trial and five minutes before patient extubation
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
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
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- N-16-2017
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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
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 .