Comparison of Synchrony Between 4 NIV Ventilators

Respiratoy Failure Requiring NIV Treatment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01615432
• Other study ID #: Synchro_Non invasive vent
• Status: Completed
• Phase: N/A
• First received: June 6, 2012
• Last updated: May 15, 2013
• Start date: June 2012
• Est. completion date: April 2013

Study information

• Verified date: May 2013
• Source: University of Lausanne Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Laws and standardsSwitzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: April 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Respiratoy Failure Requiring NIV Treatment

Intervention

Device:
• V-PAP III ventilator

• Stellar 150 ventilator

• BiPAP vision ventilator

• V60 ventilator

Locations

Country	Name	City	State
Switzerland	Intensive care and burn unit / CHUV	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient-ventilator synchrony	Patient-ventilator synchrony will be assessed breath by brath on the basis of airway pressure, flow and diaphragmatic electrical activity recordings.		No
Secondary	comfort of patient under NIV	Patient's confort during NIV will be assessed using a visual analogic scale.		No
Secondary	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.		No