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Completed

NCT Number: NCT01615432

Comparison of Synchrony Between 4 NIV Ventilators

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.

Completed

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Key information

Conditions

Respiratoy Failure Requiring NIV Treatment

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Intensive care and burn unit / CHUV

Lausanne, Canton of Vaud, 1011, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

V-PAP III ventilator

Device

Stellar 150 ventilator

Device

BiPAP vision ventilator

Device

V60 ventilator

Device

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.

Sponsors and collaborators

Lead sponsor

University of Lausanne Hospitals

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Jun 8, 2012
Registry last updated
May 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.