Respiratory Acidosis in ICU Patients Clinical Trial
— VNI Versus| Verified date | May 2018 |
| Source | University Hospital, Grenoble |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 7 |
| Est. completion date | May 5, 2018 |
| Est. primary completion date | May 5, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| France | CHU de Michallon | Grenoble |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Grenoble |
France,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Carbon dioxide arterial pressure (PaCO2) | Absolute decrease in carbon dioxide arterial pressure (PaCO2) after 2 hours of ventilation | After 2 hours of NIV | |
| Secondary | 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 | |
| Secondary | Transcutaneous PCO2 | Kinetic of the PaCO2 correction, monitored via transcutaneous PCO2 captor. | 6 hours | |
| Secondary | Börg dyspnea scale | 6 hours | ||
| Secondary | RASS score | 6 hours | ||
| Secondary | Nurse satisfaction survey | 6 hours | ||
| Secondary | Patient satisfaction survey | 6 hours |