Validation of a Simulated Clinical Evaluation of Ventilators
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.
Inclusion Criteria:

 -  Patients requiring mechanical ventilation for management of either chronic or acute
 respiratory failure.

 -  Old of at least 6 years

 -  Having given his consent writes after enlightened information, him even and the
 parents for least than 18 years, only he for most than 18 years

 -  Realization of a preliminary medical examination

 Exclusion Criteria:

 -  Patients presenting criteria of pointed exacerbation of the respiratory disease