Respiratory Acidosis in ICU Patients
Conditions
Keywords
Non-invasive ventilation, NIV ventilator, Exhalation by a calibrated leak, ICU ventilator, Respiratory acidosis, ICU
Brief summary
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.
Interventions
PROCEDURENon-Invasive Ventilation with Homecare ventilator
PROCEDURENon-Invasive Ventilation with ICU ventilator
Sponsors
University Hospital, Grenoble
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Carbon dioxide arterial pressure (PaCO2) | After 2 hours of NIV | Absolute decrease in carbon dioxide arterial pressure (PaCO2) after 2 hours of ventilation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Transcutaneous PCO2 | 6 hours | Kinetic of the PaCO2 correction, monitored via transcutaneous PCO2 captor. |
| Börg dyspnea scale | 6 hours | — |
| Arterial blood acidity (pH) after 2 hours of NIV | after 2 hours of NIV | Correction of arterial blood acidity (pH) after 2 hours of NIV |
| Nurse satisfaction survey | 6 hours | — |
| Patient satisfaction survey | 6 hours | — |
| RASS score | 6 hours | — |
Countries
France
Outcome results
None listed