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Comparison of Synchrony Between 4 NIV Ventilators

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Philippe Jolliet, University of Lausanne Hospitals
ClinicalTrials.gov Identifier:
NCT01615432
First received: June 6, 2012
Last updated: May 15, 2013
Last verified: May 2013
History of Changes
  Purpose

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 Intervention
Respiratoy Failure Requiring NIV Treatment
 Device: V-PAP III ventilator
Device: Stellar 150 ventilator
Device: BiPAP vision ventilator
Device: V60 ventilator

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Four Different Ventilators for Noninvasive Ventilation in Terms of Patient-ventilator Synchrony and Comfort

Further study details as provided by University of Lausanne Hospitals:

Primary Outcome Measures:
  • Patient-ventilator synchrony [ Designated as safety issue: No ]
    Patient-ventilator synchrony will be assessed breath by brath on the basis of airway pressure, flow and diaphragmatic electrical activity recordings.


Secondary Outcome Measures:
  • comfort of patient under NIV [ Designated as safety issue: No ]
    Patient's confort during NIV will be assessed using a visual analogic scale.

  • Ventilatory parameters [ Designated as safety issue: No ]
    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.


Enrollment: 22
Study Start Date: June 2012
Study Completion Date: April 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01615432

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

No publications provided

Responsible Party: Prof. Philippe Jolliet, Main investigator, University of Lausanne Hospitals
ClinicalTrials.gov Identifier: NCT01615432     History of Changes
Other Study ID Numbers: Synchro_Non invasive vent
Study First Received: June 6, 2012
Last Updated: May 15, 2013
Health Authority: Switzerland: Laws and standards
Switzerland: Ethikkommission

ClinicalTrials.gov processed this record on May 16, 2013