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Comparison of Synchrony Between 4 NIV Ventilators

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01615432
Enrollment
22
Registered
2012-06-08
Start date
2012-06-30
Completion date
2013-04-30
Last updated
2013-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratoy Failure Requiring NIV Treatment

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.

Interventions

DEVICEV-PAP III ventilator
DEVICEStellar 150 ventilator
DEVICEBiPAP vision ventilator
DEVICEV60 ventilator

Sponsors

University of Lausanne Hospitals
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Patient-ventilator synchronyPatient-ventilator synchrony will be assessed breath by brath on the basis of airway pressure, flow and diaphragmatic electrical activity recordings.

Secondary

MeasureTime frameDescription
comfort of patient under NIVPatient's confort during NIV will be assessed using a visual analogic scale.
Ventilatory parametersTidal 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.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026