Sustainable Preservation of Essential Oxygen Resources: A Phase 4 Crossover Study of the BUFEO System: SAVE O2

The current methods of oxygen supply administer medicinal oxygen to the patient at a constant flow. Oxygen is being delivered when the patient needs it (at inhalation) and when the patient does not need it (at exhalation and at rest) if the volume of oxygen needs to be adjusted, the clinician typically increases the rate of flow in an effort to increase the oxygen concentration in the air inhaled by the patient. This traditional way of administering oxygen is clinically effective but it also wastes significant amounts of oxygen that the patient never uses.The BUFEO system addresses this problem by altering the supply of oxygen to an on-demand delivery model, the patient receives oxygen only when needed (during inhalation) and no oxygen is wasted at rest or during exhalation.The aim of this study is to evaluate, the efficacy, tolerability, and non-inferiority in SpO2 of the BUFEO device in saving oxygen and reaching a target SpO2 rate, in comparison to the standard of care by measuring the volume of oxygen used and the SpO2 reached when administering medical oxygen with the traditional supply method and through BUFEO system to hospitalized, oxygen-dependent subjects with pulmonary pathology.

Inclusion Criteria:Able to provide signed Informed Consent; andAble to read, speak, and understand Spanish; andTarget Population - subjects must meet all of the following criteria:Between the ages of 18 and 70, inclusive; andHospitalized for a medical condition; andPrescribed supplemental oxygen of a dose ≥2 Liters/minute by a hospital physician at the time of study screening; andUtilizing a facemask or nasal cannula (as opposed to ventilator) for delivery of supplemental oxygen at the time of study screening; andDependent on supplemental oxygen by demonstrating ≥ 3% reduction (absolute value) in blood oxygenation from baseline within 3 minutes of breathing non-oxygen enriched air (i.e. room air); andWillingness to follow all study directions including refraining from activities such as making conversation, telephone calls, eating, sleeping, etc. during the study period.Exclusion Criteria:Subjects will be excluded if they meet any of the following criteria:Currently pregnant by self-report; or≤ 72 hours post myocardial infarction; orAdmitted for the treatment of a hemorrhagic or embolic cerebrovertebral accident (stroke); orBaseline Dyspnea NRS Rating of ≥ 8; orExhibiting unstable medical conditions at screening as evidenced by:Blood oxygen saturation outside of target range, defined as <88% or >92% for patients determined to be hypercapnic, or <92% or >96% for patients determined to be NOT hypercapnic; orHeart rate either < 50 beats per minute or > 100 beats per minute; orSystolic blood pressure either < 90 mm Hg or > 180 mm Hg; orDiastolic blood pressure either < 50 mm Hg or > 100 mm Hg; orRespiratory rate either < 10 or > 28 per minute; orTemperature > 38.2 C; orDifficulty obtaining / recording pulse oximetry measurements from a finger at screening; orAny reason(s) determined by the Investigator that may interfere with subject's ability to participate in study activities, may jeopardize the participant's safety or may jeopardize the quality and integrity of the data. This includes:The participant is unable to give informed consent or follow instructions during their participation in the study.The participant had any type of surgery in the past 72 hours and the Investigators do not consider the participant to be in stable condition.The Investigators anticipate failure to adequately titrate the patient to the target blood oxygen saturation for any reasonAny other reason(s) determined by the investigator.