Comparison of Synchrony Between 4 NIV Ventilators

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01615432
Recruitment Status : Completed
First Posted : June 8, 2012
Last Update Posted : May 16, 2013
Information provided by (Responsible Party):
Prof. Philippe Jolliet, University of Lausanne Hospitals

Brief Summary:
Comparison of the effects of 4 ventilators dedicated to NIV (2 home ventilators and 2 ventilators designed for NIV) on patient-ventilator synchrony and comfort in patients admitted in the intensive care unit for respiratory failure and treated with NIV.

Condition or disease Intervention/treatment Phase
Respiratoy Failure Requiring NIV Treatment Device: V-PAP III ventilator Device: Stellar 150 ventilator Device: BiPAP vision ventilator Device: V60 ventilator Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Four Different Ventilators for Noninvasive Ventilation in Terms of Patient-ventilator Synchrony and Comfort
Study Start Date : June 2012
Actual Primary Completion Date : November 2012
Actual Study Completion Date : April 2013

Primary Outcome Measures :
  1. Patient-ventilator synchrony
    Patient-ventilator synchrony will be assessed breath by brath on the basis of airway pressure, flow and diaphragmatic electrical activity recordings.

Secondary Outcome Measures :
  1. comfort of patient under NIV
    Patient's confort during NIV will be assessed using a visual analogic scale.

  2. Ventilatory parameters
    Tidal volume, respiratory rate, inspiratory time, expiratory time and maximal and mean airway pressure will be measured from the continuous recording of airway pressure and flow.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • respiratory failure

Exclusion Criteria:

  • Severe hypoxemia requiring an FiO2 > 0.6
  • Hemodynamic instability : defined as a variation of > 20% in mean arterial pressure (MAP) and heart rate (HR) during the previous 2 hours; the need for high doses of catecholamines (namely > 0.5 mcg/kg/min) and/or the need of major volume resuscitation (more than 2 liters of fluids in 2 hours)
  • Impaired consciousness or absence of patient cooperation;
  • Facial or laryngeal lesions contraindicating the use of NIV;
  • Poor short term prognosis.
  • Age < 18 years old

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01615432

Intensive care and burn unit / CHUV
Lausanne, Vaud, Switzerland, 1011
Sponsors and Collaborators
University of Lausanne Hospitals

Responsible Party: Prof. Philippe Jolliet, Main investigator, University of Lausanne Hospitals Identifier: NCT01615432     History of Changes
Other Study ID Numbers: Synchro_Non invasive vent
First Posted: June 8, 2012    Key Record Dates
Last Update Posted: May 16, 2013
Last Verified: May 2013