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
  Purpose

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 Intervention Phase
Respiratory Diseases
Chronic and Acute Respiratory Failure
Procedure: bench-evaluation, of three ventilators
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Validation of a Simulated Clinical Evaluation of Ventilators

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

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. [ Time Frame: 24 MONTHS ] [ Designated as safety issue: Yes ]

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. [ Time Frame: 24 MONTHS ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 68
Study Start Date: March 2009
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CHRONIC REPIRATORY 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: 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

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.

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01113255

Contacts
Contact: Hélène Pringent, PH +33(0)1 47 10 79 11 helene.prigent@rpc.aphp.fr

Locations
France
Hopital Raymond Poincaré Recruiting
Garches, France, 92380
Contact: helene Prigent, PH    +33(0)1 47 10 79 11 ext +33    helene.prigent@rpc.aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Hélène Prigent, ph Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01113255     History of Changes
Other Study ID Numbers: P070146
Study First Received: February 26, 2010
Last Updated: December 12, 2011
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
VENTILATORS
BENCH EVALUATION
MECHANICAL VENTILATION

Additional relevant MeSH terms:
Respiration Disorders
Respiratory Tract Diseases
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Lung Diseases

ClinicalTrials.gov processed this record on August 28, 2014