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

Tracking Information
First Received Date ^ICMJE	June 6, 2012
Last Updated Date	May 15, 2013
Start Date ^ICMJE	June 2012
Primary Completion Date	November 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 10, 2012)	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.
Original Primary Outcome Measures ^ICMJE (submitted: June 6, 2012)	Patient-ventilator synchrony [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT01615432 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 10, 2012)	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.
Original Secondary Outcome Measures ^ICMJE (submitted: June 6, 2012)	comfort of patient under NIV [ Designated as safety issue: No ] ventilatory parameters [ Designated as safety issue: No ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Comparison of Synchrony Between 4 NIV Ventilators
Official Title ^ICMJE	Comparison of Four Different Ventilators for Noninvasive Ventilation in Terms of Patient-ventilator Synchrony and Comfort
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Respiratoy Failure Requiring NIV Treatment
Intervention ^ICMJE	Device: V-PAP III ventilator Device: Stellar 150 ventilator Device: BiPAP vision ventilator Device: V60 ventilator
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	22
Completion Date	April 2013
Primary Completion Date	November 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Switzerland

Administrative Information
NCT Number ^ICMJE	NCT01615432
Other Study ID Numbers ^ICMJE	Synchro_Non invasive vent
Has Data Monitoring Committee	No
Responsible Party	Prof. Philippe Jolliet, University of Lausanne Hospitals
Study Sponsor ^ICMJE	University of Lausanne Hospitals
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Lausanne Hospitals
Verification Date	May 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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