HypoxemiaNCT04699942
Pilot Study to Evaluate the Revoxa™ System in Hypoxic Patients
A study testing Conventional (low flow) oxygen delivery via nasal cannula and Revoxa Oxygen Rebrearther in people with Hypoxemia, run by Dr. David Maslove at 1 site in Canada.
Trial summary
Patients with COVID-19 may suffer from profound hypoxia, requiring the use of supplemental oxygen at high concentrations and flow rates. Non-invasive oxygen delivery systems such as high-flow nasal cannula and non-invasive ventilation have been used in an attempt to avoid the need for intubation and invasive… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypoxemia
- What is being tested?
- Conventional (low flow) oxygen delivery via nasal cannula and Revoxa Oxygen Rebrearther
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2021to 1 May 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Group A - Healthy adults (≥ 18 years of age) with SpO2 ≥ 96% without oxygen supplementation
- Group B - non-severe hypoxemia requiring supplemental oxygen as defined by:
- SpO2 > 96% with oxygen face mask or nasal cannula with low flow oxygen <5LPM
- Adults (≥ 18 years of age)
- Group C - Hypoxemia requiring supplemental oxygen as defined by:
- Oxygen saturation (SpO2) ≤ 92% on room air as measured by pulse oximetry; or
- SpO2 < 94% with oxygen face mask or nasal cannula with low flow oxygen <5LPM
- Adults (≥ 18 years of age)
Who cannot join
- Acute / unstable cardiovascular condition
- Pregnancy
- Imminent need for intubation or noninvasive ventilation
- Glasgow coma scale <14
Trial locations and contacts
1 site in 1 country.
About this study
Patients with COVID-19 may suffer from profound hypoxia, requiring the use of supplemental oxygen at high concentrations and flow rates. Non-invasive oxygen delivery systems such as high-flow nasal cannula and non-invasive ventilation have been used in an attempt to avoid the need for intubation and invasive mechanical ventilation. These systems consume large amounts of oxygen, which prevents them from being used in areas without high pressure oxygen sources. In addition, they generate aerosols which have the potential to spread infectious pathogens from the patient's respiratory tract to healthcare workers or other patients in the environment. This study aims to investigate a computer controlled rebreather system which functions to maintain a high fraction of inspired oxygen while minimizing the production of aerosol, among hospitalized patients requiring respiratory support due to hypoxemia. The Revoxa Oxygen Rebreather device can reduce the amount of wasted oxygen and can reduce the potential for any exhaled pathogens entering the surroundings. This type of breathing device is a promising oxygen delivery treatment, but it is not clear if it can offer comparable results to standard treatment. The purpose of this study is to compare the Revoxa Oxygen Rebreather device to standard oxygen delivery methods, including nasal cannula and face mask oxygen, in order to see if similar oxygenation can be achieved at comparable or lower rates of oxygen usage.
Read the detailed description
This study aims to investigate a two-phase rebreather system (Revoxa Oxygen Rebreather device) among hospitalized patients requiring oxygen therapy. This system can deliver a high fraction of inspired oxygen (FiO2) using a very low flow oxygen source with reduced or no aerosolization. This could provide effective respiratory support with reduced waste and risk of spreading of infectious particles. Such a device could also be used in field hospitals and other makeshift care centers in the event of a surge in demand, because it obviates the need for the type of high-flow oxygen infrastructure that is typically limited to hospital settings.
This is a prospective comparative study of sequential interventions to evaluate the ability of the Revoxa Oxygen Rebreather device (RO) to improve and maintain oxygen saturation at satisfactory levels compared to conventional low-flow supplemental oxygen delivery (COD) via nasal cannula or face mask. Prior to conducting study procedures in the patient population, feasibility of trial procedures will be determined among 3 healthy adults (Group A). The initial procedural test in a healthy sample will not be included in the endpoint assessment. Following initial trial conduct in a healthy sample, 20 adult patients requiring supplemental oxygen will be recruited: adults with non-severe hypoxemia (Group B), followed by enrollment of adults with hypoxemia of any severity not requiring mechanical ventilation (Group C). Baseline measures of oxygen saturation, oxygen flow rate, vital signs (respiratory rate, heart rate, and blood pressure), and patient self-reported dyspnea and comfort will be recorded prior to initiating treatment. Following baseline measurement, either conventional low-flow oxygen delivery or oxygen via the Revoxa Oxygen Rebreather device will be initiated for 20 minutes, followed by the other modality for 20 minutes. To avoid any bias that may be introduced by a fixed sequence of device utilization (eg. COD, then RO), the order in which devices are used will be determined quasi-randomly based on whether the patient is enrolled on an odd numbered day, or an even numbered day. Vital signs, supplemental oxygen, and self-reported dyspnea measures are captured during both treatment regimens. Participants may verbally withdraw at any time by contacting one of the clinical or research staff. At that point, all data collection relating to the withdrawn study participant will be terminated. If the participant wishes, all existing data will be deleted (with the exception of the signed consent form and data related to the consent withdrawal - including the reason for the withdrawal). Additional participants will be recruited to maintain an adequate sample size in the event that participants are withdrawn from the study.
- Conditions
- Hypoxemia
- Being tested
- Conventional (low flow) oxygen delivery via nasal cannula, Revoxa Oxygen Rebrearther
- Keywords
- hypoxia, hypoxemia, oxygen delivery, COVID-19, rebreather circuit
- Medical subject headings
- Hypoxia, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional (low flow) oxygen delivery via nasal cannulaDevice
Conventional (low flow) oxygen delivery via nasal cannula or face mask for 20 minutes
Revoxa Oxygen RebreartherDevice
Oxygen delivery via Revoxa Oxygen Rebreather device for 20 minutes
| Study group | Role | What they receive |
|---|---|---|
| Conventional | Active comparator | Conventional low-flow Oxygen Delivery Receives: Device: Conventional (low flow) oxygen delivery via nasal cannula |
| Revoxa | Experimental | Oxygen Delivery via Revoxa Oxygen Rebreather Device Receives: Device: Revoxa Oxygen Rebrearther |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen flow required to achieve SpO2 >96%.
Oxygen flow required to achieve SpO2 >96%.
Measured: Baseline to 20 minutes
Secondary outcomes (4)
Average oxygen consumption
Average oxygen consumption
Measured: Baseline to 20 minutes
Peak SpO2
Peak SpO2
Measured: Baseline to 20 minutes
Patient-reported dyspnea (Modified Borg Scale)
Patient-reported dyspnea (Modified Borg Scale)
Measured: Baseline to 20 minutes
Patient-reported comfort (Visual Analogue Scale)
Patient-reported comfort (Visual Analogue Scale)
Measured: Baseline to 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start1 Feb 2021
- Primary completion1 May 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxemiaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Following baseline measurement, either conventional low-flow oxygen delivery or oxygen delivery via the Revoxa Oxygen Rebreather device is initiated for 20 minutes, followed by the other modality for 20 minutes. The order of treatments will be determined quasi-randomly based on whether the patient is enrolled on an odd-numbered day, or an even-numbered day.
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. David Maslove
- Sponsor type
- University, hospital or other
- Collaborators
- Ironstone Professional Development
- Responsible party
- Sponsor-investigator, Dr. David Maslove, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04699942
- Sponsor's protocol ID
- 6031410
- Status last verified
- Jan 2024
- First submitted
- 5 Jan 2021
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate the Revoxa™ System in Hypoxic Patients
- ClinicalTrials.gov ID
- NCT04699942
- Acronym / sponsor ID
- 6031410
- Conditions
- Hypoxemia
- Keywords
- hypoxia, hypoxemia, oxygen delivery, COVID-19, rebreather circuit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Dr. David MasloveUniversity, hospital or other
- Collaborators
- Ironstone Professional Development
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 7 Jan 2021 (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.
Patients with COVID-19 may suffer from profound hypoxia, requiring the use of supplemental oxygen at high concentrations and flow rates. Non-invasive oxygen delivery systems such as high-flow nasal cannula and non-invasive ventilation have been used in an attempt to avoid the need for intubation and invasive mechanical ventilation. These systems consume large amounts of oxygen, which prevents them from being used in areas without high pressure oxygen sources. In addition, they generate aerosols which have the potential to spread infectious pathogens from the patient's respiratory tract to healthcare workers or other patients in the environment. This study aims to investigate a computer controlled rebreather system which functions to maintain a high fraction of inspired oxygen while minimizing the production of aerosol, among hospitalized patients requiring respiratory support due to hypoxemia. The Revoxa Oxygen Rebreather device can reduce the amount of wasted oxygen and can reduce the potential for any exhaled pathogens entering the surroundings. This type of breathing device is a promising oxygen delivery treatment, but it is not clear if it can offer comparable results to standard treatment. The purpose of this study is to compare the Revoxa Oxygen Rebreather device to standard oxygen delivery methods, including nasal cannula and face mask oxygen, in order to see if similar oxygenation can be achieved at comparable or lower rates of oxygen usage.
Detailed description
This study aims to investigate a two-phase rebreather system (Revoxa Oxygen Rebreather device) among hospitalized patients requiring oxygen therapy. This system can deliver a high fraction of inspired oxygen (FiO2) using a very low flow oxygen source with reduced or no aerosolization. This could provide effective respiratory support with reduced waste and risk of spreading of infectious particles. Such a device could also be used in field hospitals and other makeshift care centers in the event of a surge in demand, because it obviates the need for the type of high-flow oxygen infrastructure that is typically limited to hospital settings.
This is a prospective comparative study of sequential interventions to evaluate the ability of the Revoxa Oxygen Rebreather device (RO) to improve and maintain oxygen saturation at satisfactory levels compared to conventional low-flow supplemental oxygen delivery (COD) via nasal cannula or face mask. Prior to conducting study procedures in the patient population, feasibility of trial procedures will be determined among 3 healthy adults (Group A). The initial procedural test in a healthy sample will not be included in the endpoint assessment. Following initial trial conduct in a healthy sample, 20 adult patients requiring supplemental oxygen will be recruited: adults with non-severe hypoxemia (Group B), followed by enrollment of adults with hypoxemia of any severity not requiring mechanical ventilation (Group C). Baseline measures of oxygen saturation, oxygen flow rate, vital signs (respiratory rate, heart rate, and blood pressure), and patient self-reported dyspnea and comfort will be recorded prior to initiating treatment. Following baseline measurement, either conventional low-flow oxygen delivery or oxygen via the Revoxa Oxygen Rebreather device will be initiated for 20 minutes, followed by the other modality for 20 minutes. To avoid any bias that may be introduced by a fixed sequence of device utilization (eg. COD, then RO), the order in which devices are used will be determined quasi-randomly based on whether the patient is enrolled on an odd numbered day, or an even numbered day. Vital signs, supplemental oxygen, and self-reported dyspnea measures are captured during both treatment regimens. Participants may verbally withdraw at any time by contacting one of the clinical or research staff. At that point, all data collection relating to the withdrawn study participant will be terminated. If the participant wishes, all existing data will be deleted (with the exception of the signed consent form and data related to the consent withdrawal - including the reason for the withdrawal). Additional participants will be recruited to maintain an adequate sample size in the event that participants are withdrawn from the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Following baseline measurement, either conventional low-flow oxygen delivery or oxygen delivery via the Revoxa Oxygen Rebreather device is initiated for 20 minutes, followed by the other modality for 20 minutes. The order of treatments will be determined quasi-randomly based on whether the patient is enrolled on an odd-numbered day, or an even-numbered day.
| Arm | Type | Receives |
|---|---|---|
| Conventional | Active comparator | Device: Conventional (low flow) oxygen delivery via nasal cannulaConventional low-flow Oxygen Delivery |
| Revoxa | Experimental | Device: Revoxa Oxygen RebreartherOxygen Delivery via Revoxa Oxygen Rebreather Device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Group A - Healthy adults (≥ 18 years of age) with SpO2 ≥ 96% without oxygen supplementation
- SpO2 > 96% with oxygen face mask or nasal cannula with low flow oxygen <5LPM
- Adults (≥ 18 years of age)
- Oxygen saturation (SpO2) ≤ 92% on room air as measured by pulse oximetry; or
- SpO2 < 94% with oxygen face mask or nasal cannula with low flow oxygen <5LPM
Key exclusion criteria (4 listed)
- Acute / unstable cardiovascular condition
- Pregnancy
- Imminent need for intubation or noninvasive ventilation
- Glasgow coma scale <14
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 |
|---|---|---|
| Conventional (low flow) oxygen delivery via nasal cannulaConventional (low flow) oxygen delivery via nasal cannula or face mask for 20 minutes | Device | Conventional |
| Revoxa Oxygen RebreartherOxygen delivery via Revoxa Oxygen Rebreather device for 20 minutes | Device | Revoxa |
Primary outcome
Oxygen flow required to achieve SpO2 >96%.
Time frame: Baseline to 20 minutes
Oxygen flow required to achieve SpO2 >96%.
4 secondary outcomes
Average oxygen consumption
Time frame: Baseline to 20 minutes
Peak SpO2
Time frame: Baseline to 20 minutes
Patient-reported dyspnea (Modified Borg Scale)
Time frame: Baseline to 20 minutes
Patient-reported comfort (Visual Analogue Scale)
Time frame: Baseline to 20 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 17 Jan 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional (low flow) oxygen delivery via nasal cannula and Revoxa Oxygen Rebrearther in people with Hypoxemia, run by Dr. David Maslove at 1 site in Canada.
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 8 inclusion and 4 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 17 Jan 2024. 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 Canada. 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?
Oxygen flow required to achieve SpO2 >96%. (time frame: Baseline to 20 minutes). 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 17 Jan 2024.