Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05677009 |
Other study ID # |
BUFEO-0572201 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
November 4, 2022 |
Est. completion date |
December 17, 2022 |
Study information
Verified date |
December 2022 |
Source |
Oxfo Corporation |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.