Efficacy and Safety of Non-invasive Ventilation by Calibrated Leak in the Treatment of Respiratory Acidosis in ICU

Study Overview
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Brief Summary
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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.

Conditions
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Respiratory Acidosis in ICU Patients

Intervention / Treatment
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* Procedure: Non-Invasive Ventilation with Homecare ventilator
* Procedure: Non-Invasive Ventilation with ICU ventilator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Dioxide carbon arterial pressure > 60 mmHg Blood acidity (pH) <7.36 Exclusion Criteria:-Patient age under 18 Pregnant woman Cognitive disorder (other than the one induced by hypercapnia) Acute intoxication with morphine or benzodiazepines Patient already equipped prior to admission with a home NIV or Continuous Positive Airway Pressure (CPAP) device All contraindications to NIV already described in the French Consensus Conference on NIV, from 2006.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Homecare ventilator<br>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<br> <br> |
| Active Comparator: ICU ventilator<br>NIV with a dedicated ICU ventilator, functioning with non-vented masks and an exhalation valve. | Procedure: Non-Invasive Ventilation with ICU ventilator<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Carbon dioxide arterial pressure (PaCO2) | Absolute decrease in carbon dioxide arterial pressure (PaCO2) after 2 hours of ventilation | After 2 hours of NIV | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial blood acidity (pH) after 2 hours of NIV | Correction of arterial blood acidity (pH) after 2 hours of NIV | after 2 hours of NIV | 
| Transcutaneous PCO2 | Kinetic of the PaCO2 correction, monitored via transcutaneous PCO2 captor. | 6 hours | 
| Börg dyspnea scale |  | 6 hours | 
| RASS score |  | 6 hours | 
| Nurse satisfaction survey |  | 6 hours | 
| Patient satisfaction survey |  | 6 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-invasive ventilation, NIV ventilator, Exhalation by a calibrated leak, ICU ventilator, Respiratory acidosis, ICU