Respiratory Diseases Clinical Trial
Official title:
Validation of a Simulated Clinical Evaluation of Ventilators
The purpose of this study is to evaluate the ability of a device reproducing patients' respiratory characteristics to select in-VITRO the most appropriate ventilator for a given pathology.
Context : Mechanical ventilation is an essential element in the management of chronic as
well as acute respiratory failure allowing an improvement of both mortality and morbidity.
However, considering the wide choice of ventilators available on the market, it has become
increasingly difficult to choose the most appropriate ventilator according to the pathology
presented by a patient, patients being able to try only a limited number of devices.
Patient-ventilator synchronization is a crucial part of ventilation efficacy and its
success. It depends on both the physiopathological characteristics of patients and specific
properties of the ventilation device.
Objective : To evaluate the ability of a device reproducing patients' respiratory
characteristics to select in-VITRO the most appropriate ventilator for a given pathology.
Method : Multi-center transversal study. Selection, after an initial bench-evaluation, of
three ventilators. Clinical evaluation of their efficacy and synchronization between patient
and ventilator and establishment of a classification.
Second bench evaluation of the studied ventilators while the bench is simulating the
ventilation characteristic of previously studied patients in order to compare the results
obtained in VITRO to the results obtained in vivo.
Selection criteria : Patients requiring mechanical ventilation for management of either
chronic or acute respiratory failure.
Patients, centers : 4 groups of 14 patients presenting chronic respiratory disease followed
in the ICU of RAYMOND POINCARE HOSPITAL in GARCHES and in the pulmonary departments of the
Armand Trousseau hospital and the PITIE SALPETRIERE IN PARIS; 1 cohort of 12 patients
admitted in the ICU of Henri Mondor in CRETEIL IN PARIS for acute respiratory failure.
Study duration : 33 months (bench study : 3 + 6 months, clinical study : 24 months)
Perspectives : Developing an evaluation tool allowing the rapid assessment of any new
available ventilator according to the specific characteristics (and needs) of a patient and
to a given pathology. Selecting the most appropriate ventilator for a given patient.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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