Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04699942 |
| Other study ID # |
6031410 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2021 |
| Est. completion date |
May 1, 2021 |
Study information
| Verified date |
January 2024 |
| Source |
Queen's University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 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.
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.
