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- Essai clinique NCT07834970
Mechanical Power During Pressure Controlled Versus Volume-Controlled Ventilation in Acute Respiratory Failure (MP-PCV-VCV)
Mechanical Power During Pressure-Controlled Versus Volume Controlled Mechanical Ventilation in Patients With Acute Respiratory Failure
This prospective observational cohort study aims to compare mechanical power between pressure-controlled ventilation (PCV) and volume-controlled ventilation (VCV) in critically ill adult patients receiving invasive mechanical ventilation. Mechanical power will be assessed at different time points during the first 24 hours after intubation, with the primary comparison performed at 24 hours. The study will also evaluate the association between mechanical power and clinical outcomes, including ICU mortality, hospital mortality, successful weaning, duration of mechanical ventilation, and length of ICU and hospital stay.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Mechanical ventilation is a life-saving intervention for critically ill patients with acute respiratory failure. However, mechanical ventilation can also contribute to ventilator-induced lung injury when excessive energy is delivered to the respiratory system. Mechanical power, which represents the energy transferred from the ventilator to the respiratory system per unit of time, has emerged as a potentially important parameter for assessing the intensity of mechanical ventilation.
The mode of ventilation may influence mechanical power through changes in airway pressure, tidal volume, respiratory rate, and inspiratory flow. Pressure-controlled ventilation (PCV) and volume-controlled ventilation (VCV) are commonly used modes of invasive mechanical ventilation, but their effects on mechanical power in critically ill patients may differ.
Therefore, this prospective observational cohort study aims to compare mechanical power between PCV and VCV in critically ill adult patients receiving invasive mechanical ventilation and to evaluate the relationship between mechanical power and relevant clinical outcomes.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Sahar Ahmed Okily, Master degree of chest disease
- Numéro de téléphone: 01094504484 0201094504484
- E-mail: sara3hmed2012@gmail.com
Sauvegarde des contacts de l'étude
- Nom: Hend Mohamed Sayed, Lecturer
- Numéro de téléphone: 0201098988712
- E-mail: Hendmohamed@aun.edu.eg
Lieux d'étude
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Asyut, Egypte
- Assuit university
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
Adult patients aged >18 years with acute respiratory failure requiring invasive mechanical ventilation and admitted to the Respiratory Intensive Care Unit at Assiut University Hospitals will be enrolled. Eligible patients receiving either pressure-controlled ventilation (PCV) or volume-controlled ventilation (VCV) will be prospectively followed during their ICU and hospital stay.
La description
Inclusion Criteria:
- Adult patients aged >18 years.
- Patients with acute respiratory failure who are receiving invasive mechanical ventilation.
Exclusion Criteria:
- Patients whose condition requires shifting between VCV and PCV after enrollment.
- Patients with neurological, neuromuscular, or muscular disorders.
- Neurological disorders, e.g., stroke, multiple sclerosis, Parkinsonism, and Guillain-Barré syndrome.
- Neuromuscular junction disorders, e.g., myasthenia gravis.
- Muscular disorders, e.g., polymyositis and Duchenne muscular dystrophy.
- Chest wall abnormalities, e.g., kyphoscoliosis, scoliosis, and pectus excavatum.
- Tracheostomized patients.
- Patients with raised intra-abdominal pressure (IAP ≥12 mmHg), as estimated by transvesical manometry e.g., massive ascites, bowel obstruction, and postoperative abdominal surgery.
- Patients with documented chronic type 2 respiratory failure, characterized by an elevated partial pressure of carbon dioxide (PaCO₂ >45 mmHg), low partial pressure of oxygen (PaO₂), and chronically elevated bicarbonate (HCO₃-) reflecting renal compensation.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: COHORT
- Perspectives temporelles: PROSPECTIVE
Cohortes et interventions
Groupe / Cohorte |
|---|
|
93 patients in Pressure controlled ventilation
93 patients in Volume controlled ventilation |
|
93 patients in PCV
93 patients in Volume controlled ventilation |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Mechanical power
Délai: 24 hours after intubation
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Mechanical power will be measured and compared between pressure-controlled ventilation (PCV) and volume-controlled ventilation (VCV) at 24 hours after intubation. |
24 hours after intubation
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
mechanical power and ICU mortality, hospital mortality, time to death.
Délai: From hospital admission until 30 days after hospital admission.
|
Correlation between mechanical power and ICU mortality, hospital mortality, time to death .
|
From hospital admission until 30 days after hospital admission.
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Mechanical power over time
Délai: At 1, 6, 12, and 24 hours after initiation of invasive mechanical ventilation.
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Changes in mechanical power over time following initiation of invasive mechanical ventilation. |
At 1, 6, 12, and 24 hours after initiation of invasive mechanical ventilation.
|
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Successful weaning from mechanical ventilation
Délai: From intubation until successful weaning( successful extubation without need for ventilatory support within the following 48 hours)
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Correlation between Mechanical power and successful weaning from mechanical ventilation .Successful weaning is defined as successful extubation without the need for re-intubation or noninvasive ventilation (NIV) within the following 48 hours. |
From intubation until successful weaning( successful extubation without need for ventilatory support within the following 48 hours)
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Olfat Mostafa El shinawy, Professor, Assiut University, Faculty of Medicine, Chest Diseases Department, Assiut, Egypt
- Directeur d'études: Sara Mohamed Hashem, Lecteurer, Assiut University, Faculty of Medicine, Chest Diseases Department, Assiut, Egypt
Publications et liens utiles
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
Autres numéros d'identification d'étude
- AUN-CH-MP-001
Informations sur les médicaments et les dispositifs, documents d'étude
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