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

NCT05677009 | Completed

• 1 other identifier: BUFEO-0572201
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Oxygen Deficiency; Oxygen Therapy

Keywords

oxygen

Outcome Measures

Primary Outcomes (2)

• SpO2 Analysis

  The ability of the BUFEO device to maintain blood oxygenation levels comparable to standard, continuous oxygen delivery will be assessed through the use of continuous pulse oximetry recorded every 1 minute by the study staff on the paper data forms, as well as every 2 seconds digitally by the oximeter during BUFEO Condition and Standard Condition. The average and standard deviation of these recorded SpO2 values from minute 0 to 20 (20 minutes total) will be documented for data analysis of the primary endpoint. Total time in and out of the target range will be calculated for the 20-minute total duration.

  from date of screening through visit completion or early termination up to 60 minutes

• Quantitative Oxygen Consumption Analysis

  The study will use the Digital Gas Mems Mass Flow Meter Model Mf5712 (0-200 L/min; 0.8 MPa; Siargo, Ltd.) to measure and monitor in-line mass flow rate of oxygen for both study conditions. Total volume from minute 0 to minute 20 will be used in data analyses for the BUFEO Condition and Standard Condition, after the 3-minute stabilization period to allow subjects to acclimate to the new mask or cannula and apparatus of each condition.

  from date of randomization until visit completion or early termination up to 60 minutes

Secondary Outcomes (2)

• Patient-reported dyspnea

  from date of screening through visit completion or early termination up to 60 minutes

• Patient-reported discomfort

  from date of screening through visit completion or early termination up to 60 minutes

Study Arms (1)

BUFEO vs Standard Condition

OTHER

In the BUFEO vs Standard Condition arm, the patient will receive both treatments. The order in which the subject receives the treatment will be randomized.

Device: BUFEO system; Other: Standard of Care

Interventions

BUFEO system DEVICE

In the BUFEO Condition, the subject will receive oxygen through the BUFEO system.

Also known as: BUFEO Condition

BUFEO vs Standard Condition

Standard of Care OTHER

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.

Also known as: Standard Condition

BUFEO vs Standard Condition

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to provide signed Informed Consent; and
• Able to read, speak, and understand Spanish; and
• Target Population - subjects must meet all of the following criteria:
• Between the ages of 18 and 70, inclusive; and
• Hospitalized for a medical condition; and
• Prescribed supplemental oxygen of a dose ≥2 Liters/minute by a hospital physician at the time of study screening; and
• Utilizing a facemask or nasal cannula (as opposed to ventilator) for delivery of supplemental oxygen at the time of study screening; and
• Dependent 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); and
• Willingness to follow all study directions including refraining from activities such as making conversation, telephone calls, eating, sleeping, etc. during the study period.

You may not qualify if:

• Subjects will be excluded if they meet any of the following criteria:
• Currently pregnant by self-report; or
• ≤ 72 hours post myocardial infarction; or
• Admitted for the treatment of a hemorrhagic or embolic cerebrovertebral accident (stroke); or
• Baseline Dyspnea NRS Rating of ≥ 8; or
• Exhibiting 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; or
• Heart rate either \< 50 beats per minute or \> 100 beats per minute; or
• Systolic blood pressure either \< 90 mm Hg or \> 180 mm Hg; or
• Diastolic blood pressure either \< 50 mm Hg or \> 100 mm Hg; or
• Respiratory rate either \< 10 or \> 28 per minute; or
• Temperature \> 38.2 C; or
• Difficulty obtaining / recording pulse oximetry measurements from a finger at screening; or
• Any 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.

Sponsors & Collaborators

• Oxfo Corporation: lead

Study Sites (1)

Hospital Alma Máter de Antioquia

Medellín, Antioquia, Colombia

Location

MeSH Terms

Conditions

Hypoxia

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Carlos Bazoberry, MD

  Director

  STUDY DIRECTOR

• Susana Osorno, MD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: January 10, 2023
• Study Start: November 4, 2022
• Primary Completion: December 17, 2022
• Study Completion: December 17, 2022
• Last Updated: January 10, 2023

Record last verified: 2022-12

Locations

CO (1)