Validation of a Simulated Clinical Evaluation of Ventilators

Phase 2

Completed

• Conditions: Chronic and Acute Respiratory Failure; Respiratory Diseases
• Interventions: Procedure: bench-evaluation, of three ventilators

• Registration Number: NCT01113255
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

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 Timeline

• Study Start: 2009-03
• Study First Submitted: 2010-02-26
• Study First Submitted QC: 2010-04-28
• Study First Posted: 2010-04-29
• Primary Completion: 2011-09
• Study Completion: 2011-12
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-05
• Last Update Posted: 2014-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

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Exclusion Criteria

• Patients presenting criteria of pointed exacerbation of the respiratory disease

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CHRONIC REPIRATORY FAILURE	bench-evaluation, of three ventilators	-
ACUTE RESPIRATORY FAILURE	bench-evaluation, of three ventilators	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Hopital Raymond Poincaré; 🇫🇷 Garches, France