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CompletedNCT01615432Updated May 16, 2013

Comparison of Synchrony Between 4 NIV Ventilators

An interventional study of V-PAP III ventilator and Stellar 150 ventilator in Respiratoy Failure Requiring NIV Treatment, sponsored by University of Lausanne Hospitals. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-05-16.

Sponsored by University of Lausanne Hospitals · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Respiratoy Failure Requiring NIV Treatment
03

In context

Lead sponsor

University of Lausanne Hospitals is the lead sponsor of 118 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • respiratory failure

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
22 participants (actual)

Interventions

  • DeviceV-PAP III ventilator
  • DeviceStellar 150 ventilator
  • DeviceBiPAP vision ventilator
  • DeviceV60 ventilator
06

What researchers measure

Primary outcomes

  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 outcomes

  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.

07

Study locations

1 site
  • Intensive care and burn unit / CHUV
    Lausanne, Vaud 1011, Switzerland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01615432
Lead sponsor
University of Lausanne Hospitals
Responsible party
Prof. Philippe Jolliet (Main investigator, University of Lausanne Hospitals) — Principal investigator
First posted
Jun 8, 2012
Start date
Jun 2012
Primary completion
Nov 2012
Completion
Apr 2013
Last update
May 16, 2013

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.

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