Comparison of Synchrony Between 4 NIV Ventilators

Comparison of Four Different Ventilators for Noninvasive Ventilation in Terms of Patient-ventilator Synchrony and Comfort

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.

Study Overview

• Status: Completed
• Conditions: Respiratoy Failure Requiring NIV Treatment
• Intervention / Treatment: Device: V-PAP III ventilator; Device: Stellar 150 ventilator; Device: BiPAP vision ventilator; Device: V60 ventilator

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Vaud
    • Lausanne, Vaud, Switzerland, 1011
      • Intensive care and burn unit / CHUV

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description
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

Outcome Measure	Measure Description
comfort of patient under NIV	Patient's confort during NIV will be assessed using a visual analogic scale.
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.

Collaborators and Investigators

• Sponsor: University of Lausanne Hospitals

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: June 6, 2012
• First Submitted That Met QC Criteria: June 6, 2012
• First Posted (Estimate): June 8, 2012

Study Record Updates

• Last Update Posted (Estimate): May 16, 2013
• Last Update Submitted That Met QC Criteria: May 15, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: Synchro_Non invasive vent