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

Grenoble Alpes University Hospital Center (CHU)

Status: Terminated

Conditions: Respiratory Acidosis in ICU Patients

Treatments: Procedure: Non-Invasive Ventilation with ICU ventilator; Procedure: Non-Invasive Ventilation with Homecare ventilator

Study type: Interventional

Funder types: Other

Identifiers

NCT02630784

2014-A00844-43

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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7 participants in 2 patient groups

Homecare ventilator

Experimental group

Description:

NIV with a dedicated ventilator for homecare, functioning with a turbine and with vented mask (exhalation by a calibrated leak)

Treatment:

Procedure: Non-Invasive Ventilation with Homecare ventilator

ICU ventilator

Active Comparator group

Description:

NIV with a dedicated ICU ventilator, functioning with non-vented masks and an exhalation valve.

Treatment:

Procedure: Non-Invasive Ventilation with ICU ventilator