Clinical trial NCT02630784: Efficacy and Safety of Non-invasive Ventilation by Calibrated Leak in the Treatment of Respiratory Acidosis in ICU
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Respiratory Acidosis in ICU Patients
Keywords: Non-invasive ventilation
NIV ventilator
Exhalation by a calibrated leak
ICU ventilator
Respiratory acidosis
ICU
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2015-12-15
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Carbon dioxide arterial pressure (PaCO2)
timeFrame: After 2 hours of NIV
Secondary outcomes:
measure: Arterial blood acidity (pH) after 2 hours of NIV
timeFrame: after 2 hours of NIV
measure: Transcutaneous PCO2
timeFrame: 6 hours
measure: Börg dyspnea scale
timeFrame: 6 hours
measure: RASS score
timeFrame: 6 hours
measure: Nurse satisfaction survey
timeFrame: 6 hours
measure: Patient satisfaction survey
timeFrame: 6 hours
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU de Michallon
Study officials:
References:
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citation: Ferrer M, Sellares J, Valencia M, Carrillo A, Gonzalez G, Badia JR, Nicolas JM, Torres A. Non-invasive ventilation after extubation in hypercapnic patients with chronic respiratory disorders: randomised controlled trial. Lancet. 2009 Sep 26;374(9695):1082-8. doi: 10.1016/S0140-6736(09)61038-2. Epub 2009 Aug 12.
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citation: Janssens JP, Howarth-Frey C, Chevrolet JC, Abajo B, Rochat T. Transcutaneous PCO2 to monitor noninvasive mechanical ventilation in adults: assessment of a new transcutaneous PCO2 device. Chest. 1998 Mar;113(3):768-73. doi: 10.1378/chest.113.3.768.
citation: Peter JV, Moran JL, Phillips-Hughes J, Graham P, Bersten AD. Effect of non-invasive positive pressure ventilation (NIPPV) on mortality in patients with acute cardiogenic pulmonary oedema: a meta-analysis. Lancet. 2006 Apr 8;367(9517):1155-63. doi: 10.1016/S0140-6736(06)68506-1.