Pilot Clinical Investigation to Evaluate a Prototype of Sensor Measuring Ventilator-derived Parameters

Inclusion criteria

• Male or female patient aged 18 years or above
• Patient ventilated with the reference ventilators: Servo U - Maquet Critical Care AB, Röntgenvägen 2, 171 54 Solna, Sweden for intensive care unit or Perseus - Drägerwerk AG & Co. KGaA, Moislinger Allee 53-55, 23542 Lübeck, Germany for operating room
• Sedated patient with or without NBA (Neuromuscular Blocking Agent)
• Patient with a positive end-expiratory pressure (PEEP) ≤ 10 cm H2O
• Patient stable without recent (less than one hour) or planned intervention (such a bronchoscopy, prone positioning, physiotherapy)
• The primary attending physician approves use of the protocol on the patient
• Anticipated length of intubation > 2 hours per patient
• The patient or legally authorized representative has signed and dated a written Informed Consent Form (ICF) prior to the initiation of any clinical investigation procedures
• Patient affiliated to the French social security regimen
• Procedure will be performed at least 30 minutes after inhaled treatment (eg salbutamol)

Exclusion criteria

• Patient with a serious disease, for which the ventilation unplugging during a few seconds could have a serious impact (particularly patients with PaO2/Fi02 < 150 with pH < 7,30, with PEEP > 10 cm H20, or with Fi02 > 50%)
• Patient with disease judged by the investigator to be incompatible with the conduct of the clinical investigation procedures or the interpretation of the clinical investigation results (example: IG-bronchopleural fistula)
• Patient with a significant lower airway obstruction (asthma…), confirmed by ventilator spirometry.
• Inability to maintain the airway intubation
• Patient with a recent history of cardiac and/or respiratory arrest
• Patient with multiple-organ system failure
• Patient with hemodynamic instability (tachycardia, rapid change of vasopressor)
• Pregnancy
• Participation in another clinical investigation at the same time as the present clinical investigation
• Nitric oxide use