Validation of a Simulated Clinical Evaluation of Ventilators (SIMULVENTI)

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Diseases; Chronic and Acute Respiratory Failure
• Intervention / Treatment: Procedure: bench-evaluation, of three ventilators

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 Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• France
  • Garches, France, 92380
    • Hopital Raymond Poincare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Hélène Prigent, ph, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (ACTUAL): September 1, 2011
• Study Completion (ACTUAL): December 1, 2011

Study Registration Dates

• First Submitted: February 26, 2010
• First Submitted That Met QC Criteria: April 28, 2010
• First Posted (ESTIMATE): April 29, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): November 6, 2014
• Last Update Submitted That Met QC Criteria: November 5, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: MECHANICAL VENTILATION; VENTILATORS; BENCH EVALUATION
• Additional Relevant MeSH Terms: Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases
• Other Study ID Numbers: P070146