Oxygen DeficiencySAVEO2NCT05677009
Sustainable Preservation of Essential Oxygen Resources: A Phase 4 Crossover Study of the BUFEO System: SAVE O2
A study testing BUFEO system in people with Oxygen Deficiency and Oxygen Therapy, run by Oxfo Corporation at 1 site in Colombia.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Oxygen Deficiency, Oxygen Therapy
- What is being tested?
- BUFEO system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteColombia
- Study dates
- 4 Nov 2022to 17 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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:
Show all 18Show fewer
- 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.
- 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 reason
- Any other reason(s) determined by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sustainable Preservation of Essential Oxygen Resources: A Phase 4 Crossover Study of the Efficacy, Tolerability and SpO2 Non-inferiority 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.
Read the 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.
- Conditions
- Oxygen Deficiency, Oxygen Therapy
- Being tested
- BUFEO system, Standard of Care
- Keywords
- oxygen
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BUFEO systemDevice
Also called BUFEO Condition
In the BUFEO Condition, the subject will receive oxygen through the BUFEO system.
Standard of CareOther
Also called Standard Condition
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: BUFEO system; Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: from date of randomization until visit completion or early termination up to 60 minutes
Secondary outcomes (2)
Patient-reported dyspnea
Tolerability will be assessed with use of the Dyspnea Numeric Rating Scale (NRS). The Dyspnea NRS will be shown to the subject in printed form, and read aloud verbally to elicit a verbal response from the subject, which will be recorded. The Dyspnea NRS asks "How short-of-breath is the participant right now?" This 11-point scale is anchored at 0- "none at all" and 10- "worst shortness of breath imaginable".
Measured: from date of screening through visit completion or early termination up to 60 minutes
Patient-reported discomfort
Discomfort will be assessed with use of the Discomfort Numeric Rating Scale (NRS). The Discomfort NRS will be shown to the subject in printed form, and read aloud verbally to elicit a verbal response from the subject, which will be recorded. The Discomfort NRS asks "How much discomfort does the participant feel right now breathing through this mask?" This 11-point scale is anchored at 0- "no discomfort at all" and 10-"worst discomfort imaginable".
Measured: from date of screening through visit completion or early termination up to 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start4 Nov 2022
- Primary completion17 Dec 2022
- Study completion17 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxygen DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxfo Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carlos Bazoberry, MD, Study director, DirectorSusana Osorno, MD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05677009
- Sponsor's protocol ID
- BUFEO-0572201
- Acronym
- SAVEO2
- Status last verified
- Dec 2022
- First submitted
- 13 Jun 2022
- Last updated
- 10 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sustainable Preservation of Essential Oxygen Resources: A Phase 4 Crossover Study of the Efficacy, Tolerability and SpO2 Non-inferiority of the BUFEO System: SAVE O2
- ClinicalTrials.gov ID
- NCT05677009
- Acronym / sponsor ID
- SAVEO2 / BUFEO-0572201
- Conditions
- Oxygen Deficiency, Oxygen Therapy
- Keywords
- oxygen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Oxfo CorporationIndustry (pharma, biotech, devices)
- Study start
- 4 Nov 2022 (actual)
- Primary completion
- 17 Dec 2022 (actual)
- Study completion
- 17 Dec 2022 (actual)
- First posted
- 10 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| BUFEO vs Standard Condition | Other | Device: BUFEO system, Other: Standard of CareIn the BUFEO vs Standard Condition arm, the patient will receive both treatments. The order in which the subject receives the treatment will be randomized. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- Willingness to follow all study directions including refraining from activities such as making conversation, telephone calls, eating, sleeping, etc. during the study period.
Key exclusion criteria (18 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BUFEO systemAlso: BUFEO ConditionIn the BUFEO Condition, the subject will receive oxygen through the BUFEO system. | Device | BUFEO vs Standard Condition |
| Standard of CareAlso: Standard ConditionStandard 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 | BUFEO vs Standard Condition |
Primary outcome
SpO2 Analysis
Time frame: from date of screening through visit completion or early termination up to 60 minutes
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.
Quantitative Oxygen Consumption Analysis
Time frame: from date of randomization until visit completion or early termination up to 60 minutes
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.
2 secondary outcomes
Patient-reported dyspnea
Time frame: from date of screening through visit completion or early termination up to 60 minutes
Patient-reported discomfort
Time frame: from date of screening through visit completion or early termination up to 60 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos Bazoberry, MD study director
Director
Susana Osorno, MD principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BUFEO system in people with Oxygen Deficiency and Oxygen Therapy, run by Oxfo Corporation at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SpO2 Analysis (time frame: from date of screening through visit completion or early termination up to 60 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2023; AzTrials last refreshed its copy on 7 Nov 2026.