Pilot Physiological Evaluation of an Investigational Mask With Expiratory Washout.
Acute Hypercapnic Respiratory Failure, Acute Hypoxemic Respiratory Failure
About this trial
This is an interventional treatment trial for Acute Hypercapnic Respiratory Failure focused on measuring Non-invasive Ventilation
Eligibility Criteria
Inclusion Criteria: No indication of intubation upon evaluation by physician in the next 2 hours Fits the investigational mask Specific for hypercapnic patients 1 of the following criteria Patients hospitalized with acute respiratory failure (ARF) stabilized and tolerating NIV or; Patient admitted to hospital with ARF with one criteria for NIV among the following: Acute hypercapnic respiratory failure with hypercapnia and acidosis (Partial pressure of arterial carbon dioxide (PaCO2) > 45 millimeters of mercury (mmHg) and pH < 7.38) or Post-extubation period within 48 hours, in patients with high risk of re-intubation Specific for hypoxemic patients 1 of the following criteria Hypoxemic respiratory failure without hypercapnia requiring nasal high flow or; Hypoxemic respiratory failure without hypercapnia requiring NIV or; Conventional oxygen therapy (COT) > 6 liters per minute (L/min) with peripheral oxygen saturation (SpO2) < 92% Exclusion Criteria: Refusal to participate in the study Inability to provide informed consent Infectious isolation Facial deformity, burns or morphology that prevents adequate mask placement Claustrophobia Nausea Presence of nasogastric tube Pneumothorax Confusion or loss of consciousness Severe upper gastro-intestinal bleeding Any other condition, which at the investigators discretion, is believed may present a safety risk or impact the feasibility of the study or study results
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Active Comparator
Single-limb non-invasive ventilation with expiratory washout
Single-limb non-invasive ventilation
Dual-limb non-invasive ventilation
In a random order, 30 minute period of non-invasive ventilation using the investigational mask, a vented full-face mask with expiratory washout
In a random order, 30 minute period of non-invasive ventilation with a conventional vented full-face mask (RT077 or equivalent)
In a random order, 30 minute period of non-invasive ventilation with a conventional vented full-face mask (RT076 or equivalent)