SIMULVENTI: Validation of a Simulated Clinical Evaluation of Ventilators

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Completed

CT.gov ID

NCT01113255

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Diseases Chronic and Acute Respiratory Failure	Procedure: bench-evaluation, of three ventilators	Phase 2/Phase 3

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

54 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Validation of a Simulated Clinical Evaluation of Ventilators

Study Start Date :

Mar 1, 2009

Actual Primary Completion Date :

Sep 1, 2011

Actual Study Completion Date :

Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: CHRONIC REPIRATORY FAILURE	Procedure: bench-evaluation, of three ventilators to select in-VITRO the most appropriate ventilator for a given pathology. Other Names: Mechanical ventilation
Active Comparator: ACUTE RESPIRATORY FAILURE	Procedure: bench-evaluation, of three ventilators to select in-VITRO the most appropriate ventilator for a given pathology. Other Names: Mechanical ventilation

Arm

Intervention/Treatment

Active Comparator: CHRONIC REPIRATORY FAILURE

Procedure: bench-evaluation, of three ventilators

to select in-VITRO the most appropriate ventilator for a given pathology.

Other Names:

Mechanical ventilation

Active Comparator: ACUTE RESPIRATORY FAILURE

Procedure: bench-evaluation, of three ventilators

to select in-VITRO the most appropriate ventilator for a given pathology.

Other Names:

Mechanical ventilation

Outcome Measures

Primary Outcome Measures

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. [24 MONTHS]

Secondary Outcome Measures

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. [24 MONTHS]

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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