Validation of a Simulated Clinical Evaluation of Ventilators

NCT01113255 | Completed Phase 2

• 1 other identifier: P070146
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Respiratory Diseases; Chronic and Acute Respiratory Failure

Keywords

VENTILATORS; BENCH EVALUATION; MECHANICAL VENTILATION

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

CHRONIC REPIRATORY FAILURE

ACTIVE COMPARATOR

Procedure: bench-evaluation, of three ventilators

ACUTE RESPIRATORY FAILURE

ACTIVE COMPARATOR

Procedure: bench-evaluation, of three ventilators

Interventions

bench-evaluation, of three ventilators PROCEDURE

to select in-VITRO the most appropriate ventilator for a given pathology.

Also known as: Mechanical ventilation

ACUTE RESPIRATORY FAILURE; CHRONIC REPIRATORY FAILURE

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients presenting criteria of pointed exacerbation of the respiratory disease

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hopital Raymond Poincaré

Garches, 92380, France

Location

MeSH Terms

Conditions

Respiratory Tract Diseases; Bronchiolitis Obliterans Syndrome

Interventions

Respiration, Artificial

Condition Hierarchy (Ancestors)

Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Resuscitation; Emergency Treatment; Respiratory Therapy

Study Officials

• Hélène Prigent, ph

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2010
• First Posted: April 29, 2010
• Study Start: March 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: December 1, 2011
• Last Updated: November 6, 2014

Record last verified: 2014-11

Locations

FR (1)