Efficacy and Safety of Non-invasive Ventilation by Calibrated Leak in the Treatment of Respiratory Acidosis in ICU (VNI Versus)
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|ClinicalTrials.gov Identifier: NCT02630784|
Recruitment Status : Terminated (lack of enrollement)
First Posted : December 15, 2015
Last Update Posted : May 14, 2018
VNI Versus is a clinical, prospective, randomized, cross over study, aiming to compare two mechanical ventilators during non-invasive ventilation for patient suffering from respiratory acidosis.
This study will compare a dedicated ventilator for Non Invasive Ventilation (NIV) functioning with a turbine and with vented mask (exhalation by a calibrated leak) and a dedicated ventilator for Intensive Care Unit (ICU), functioning with non-vented masks and an exhalation valve.
Patient will be randomized before the first NIV session lasting 2 hours. After a two hours wash-out, a second NIV treatment will be delivered with the other ventilator for duration of 2 hours.
Arterial blood samples will be collected at the beginning and the end of each session of NIV. A transcutaneous captor of dioxide carbon pressure (PCO2) will also be used for patient monitoring.
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Acidosis in ICU Patients||Procedure: Non-Invasive Ventilation with Homecare ventilator Procedure: Non-Invasive Ventilation with ICU ventilator||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Crossover Assignment|
|Actual Study Start Date :||May 27, 2015|
|Actual Primary Completion Date :||May 5, 2018|
|Actual Study Completion Date :||May 5, 2018|
Experimental: Homecare ventilator
NIV with a dedicated ventilator for homecare, functioning with a turbine and with vented mask (exhalation by a calibrated leak)
Procedure: Non-Invasive Ventilation with Homecare ventilator
Active Comparator: ICU ventilator
NIV with a dedicated ICU ventilator, functioning with non-vented masks and an exhalation valve.
Procedure: Non-Invasive Ventilation with ICU ventilator
- Carbon dioxide arterial pressure (PaCO2) [ Time Frame: After 2 hours of NIV ]Absolute decrease in carbon dioxide arterial pressure (PaCO2) after 2 hours of ventilation
- Arterial blood acidity (pH) after 2 hours of NIV [ Time Frame: after 2 hours of NIV ]Correction of arterial blood acidity (pH) after 2 hours of NIV
- Transcutaneous PCO2 [ Time Frame: 6 hours ]Kinetic of the PaCO2 correction, monitored via transcutaneous PCO2 captor.
- Börg dyspnea scale [ Time Frame: 6 hours ]
- RASS score [ Time Frame: 6 hours ]
- Nurse satisfaction survey [ Time Frame: 6 hours ]
- Patient satisfaction survey [ Time Frame: 6 hours ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02630784
|CHU de Michallon|
|Grenoble, France, 38000|