Validation of a Simulated Clinical Evaluation of Ventilators

Respiratory Diseases Clinical Trial

— SIMULVENTI  

Official title:

Validation of a Simulated Clinical Evaluation of Ventilators

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01113255
• Other study ID #: P070146
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 26, 2010
• Last updated: November 5, 2014
• Start date: March 2009
• Est. completion date: December 2011

Study information

• Verified date: November 2014
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic and Acute Respiratory Failure
• Respiration Disorders
• Respiratory Diseases
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency
• Respiratory Tract Diseases

Intervention

Procedure:
• bench-evaluation, of three ventilators
to select in-VITRO the most appropriate ventilator for a given pathology.

Locations

Country	Name	City	State
France	Hopital Raymond Poincaré	Garches

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes