Validation of a Simulated Clinical Evaluation of Ventilators (SIMULVENTI)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01113255
First received: February 26, 2010
Last updated: December 12, 2011
Last verified: June 2011

February 26, 2010
December 12, 2011
March 2009
March 2012   (final data collection date for primary outcome measure)
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. [ Time Frame: 24 MONTHS ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01113255 on ClinicalTrials.gov Archive Site
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. [ Time Frame: 24 MONTHS ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Respiratory Diseases
  • Chronic and Acute Respiratory Failure
Procedure: bench-evaluation, of three ventilators
to select in-VITRO the most appropriate ventilator for a given pathology.
Other Name: Mechanical ventilation
  • Active Comparator: CHRONIC REPIRATORY FAILURE
    Intervention: Procedure: bench-evaluation, of three ventilators
  • Active Comparator: ACUTE RESPIRATORY FAILURE
    Intervention: Procedure: bench-evaluation, of three ventilators
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
68
March 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
6 Years and older
No
Contact: Hélène Pringent, PH +33(0)1 47 10 79 11 helene.prigent@rpc.aphp.fr
France
 
NCT01113255
P070146
No
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Hélène Prigent, ph Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP