Sustainable Preservation of Essential Oxygen Resources: A Phase 4 Crossover Study of the BUFEO System: SAVE O2
Condition: Oxygen Deficiency; Oxygen Therapy
MeSH terms: Hypoxia
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      The BUFEO system is a class 2a device that saves oxygen by altering the supply of oxygen to
      an on-demand delivery model through the insertion of a reservoir between the oxygen source
      and the patient. The reservoir accepts oxygen from the pressurized source where it is
      converted to ambient pressure. The BUFEO reservoir is approximately 1.75 Liters in volume
      and, once full, a shut-off valve automatically stops the flow of oxygen from the source and
      continues to hold the oxygen at ambient pressure. The rate of flow to BUFEO from the oxygen
      cylinder has no bearing on the volume or concentration of oxygen dispensed to the subject;
      the only change in the oxygen when entering the reservoir bag from the pressurized source is
      that it becomes ambient pressure. BUFEO is designed to be connected directly to the
      pressurized source, typically 50 psi in hospital settings. From the reservoir, oxygen is
      withdrawn on-demand by the patient's inhalation. After a certain volume is withdrawn from the
      BUFEO reservoir, the valve is triggered to open and refill from the pressurized source. The
      rate of flow from the pressurized source to BUFEO affects only the rate at which the
      reservoir refills upon valve opening; it has no effect on the rate of flow to the mask. Only
      the volume that the subject inhales on their own is dispensed at the rate of inhalation.
      Similar to continuous oxygen delivery systems, oxygen from the BUFEO reservoir is available
      to the patient at the start of the next inspiration. Unlike continuous delivery systems, the
      flow of oxygen to the patient stops upon the start of expiration. As a result, BUFEO's
      on-demand model of oxygen delivery greatly reduces waste.

      In addition to the conservation of oxygen dispensed, BUFEO also provides efficiency by
      delivering a high concentration of oxygen (99.9%) directly from the reservoir. In contrast to
      the standard pressurized delivery of oxygen where one titrates the concentration of oxygen
      upward by increasing the rate of flow, the BUFEO device requires a downward titration to
      reduce the concentration of oxygen. The dilution can be done by allowing a set amount of room
      air to be entrained and blend with the oxygen as it flows from the reservoir to the patient's
      mask or cannula.

      Safety Assessments Vital Signs

      Vital signs will be recorded during the study at various points.

      Physical Exam

      All subjects will undergo a brief, focused physical exam at screening that includes an
      examination of the heart and lungs.

      BUFEO device monitoring

      BUFEO device is an attachment to the oxygen delivery system that allows for unobstructed,
      on-demand access to oxygen contained in the device's reservoir. Each BUFEO device has
      undergone thorough quality control testing at the point of manufacturing. Each BUFEO device
      will also undergo testing by study staff prior to the delivery of any study assessments or
      treatment as indicated by instructions in the BUFEO operation manual. The study staff will
      also ensure that the device is turned on via examination of the device's power switch
      indicator prior to the delivery of any study assessments or treatment.

      Oxygen Monitoring

      Subjects will be continuously monitored by study staff during the course of the study.
      Subjects' oxygenation levels will also be monitored continuously with the use of a pulse
      oximeter, the results of which will be recorded in the study's source documents.

      Data Collection and Management Data Management

      Source documents provide evidence for the existence of the study participant and substantiate
      the integrity of the data collected. Study data will be recorded on the provided study source
      documents. Study source documents, including the participant's original signed informed
      consent, will be kept and securely maintained at the research site. The investigator must
      retain all study records and source documents for the maximum time period required by local
      regulations. Only study staff will have access to study source documents.

      Source documents will be scanned and sent to the sponsor for quality assurance and data
      analysis. Any queries will be sent to the study team for reconciliation.

      All final data will be entered into a secure Excel file using double data entry. A final
      review and database lock will be completed after all queries have been resolved.

      Confidentiality

      All information generated in this study is considered confidential and must not be disclosed
      to any person or entity not directly involved with the study without prior written consent
      from the sponsor. Identification of study participants will be via subject initials and
      assigned study numbers. Study numbers will be assigned to all subjects (including those who
      screen fail) at the time of screening. Any participant records or data transferred to the
      sponsor will contain only these identifiers.

      ETHICS AND RESPONSIBILITIES

      This study will be conducted in compliance with the protocol, Good Clinical Practice (GCP),
      International Conference on Harmonization (ICH) guidelines, and all applicable local
      regulations. The protocol will receive Institutional Review Board/Ethics Committee approval
      prior to the initiation of study activities. The investigator is responsible for submitting
      the protocol and information regarding Serious Adverse Events to the Ethics Committee. All
      ethics committee correspondence will be kept with the study records.
    

Intervention name(s): BUFEO system; Standard of Care
Intervention type(s): Device; Other
Intervention description(s): In the BUFEO Condition, the subject will receive oxygen through the BUFEO system.; Standard Condition is the baseline apparatus utilized by the subject at the time of enrollment in the study. In the hospital setting, the supplemental oxygen delivery may come from compressed oxygen cylinders or liquid oxygen and is often delivered through a port in the facility wall at the bedside.
Other intervention name(s): BUFEO Condition; Standard Condition
Intervention model: Single Group Assignment
Intervention model description: This is a prospective, unblinded, single-center study examining the safety, efficacy, and tolerability of BUFEO device compared to standard of care in hospitalized, oxygen-dependent subjects. In this single-visit study, each visit is expected to be approximately 120 minutes. The total study duration to complete 20 subjects (10 males and 10 females) is expected to be 4 weeks.
Masking: None (Open Label)
Primary purpose: Other
Keywords: oxygen