Validation of a Simulated Clinical Evaluation of Ventilators (SIMULVENTI)
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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 |
- 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 ]
- 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 |
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| Contact: Hélène Pringent, PH | +33(0)1 47 10 79 11 | helene.prigent@rpc.aphp.fr |
| 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 | |
| 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 May 22, 2013