We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pilot Study to Evaluate the Revoxa™ System in Hypoxic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04699942
Recruitment Status : Not yet recruiting
First Posted : January 7, 2021
Last Update Posted : January 7, 2021
Sponsor:
Collaborator:
Ironstone Professional Development
Information provided by (Responsible Party):
Dr. David Maslove, Queen's University

Brief 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.

Condition or disease Intervention/treatment Phase
Hypoxemia Device: Conventional (low flow) oxygen delivery via nasal cannula Device: Revoxa Oxygen Rebrearther Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention 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)
Primary Purpose: Supportive Care
Official Title: Pilot Study to Evaluate the Revoxa™ System in Hypoxic Patients
Estimated Study Start Date : January 4, 2021
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Active Comparator: Conventional low-flow Oxygen Delivery Device: Conventional (low flow) oxygen delivery via nasal cannula
Conventional (low flow) oxygen delivery via nasal cannula or face mask for 20 minutes

Experimental: Oxygen Delivery via Revoxa Oxygen Rebreather Device Device: Revoxa Oxygen Rebrearther
Oxygen delivery via Revoxa Oxygen Rebreather device for 20 minutes




Primary Outcome Measures :
  1. Oxygen flow required to achieve SpO2 >96%. [ Time Frame: Baseline to 20 min ]

Secondary Outcome Measures :
  1. Average oxygen consumption [ Time Frame: Baseline to 20 min ]
  2. Peak SpO2 [ Time Frame: Baseline to 20 min ]
  3. Patient-reported dyspnea (Modified Borg Scale) [ Time Frame: Baseline to 20 min ]
  4. Patient-reported comfort (Visual Analogue Scale) [ Time Frame: Baseline to 20 min ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

  • Acute / unstable cardiovascular condition
  • Pregnancy
  • Imminent need for intubation or noninvasive ventilation
  • Glasgow coma scale <14

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04699942


Contacts
Layout table for location contacts
Contact: David Maslove, MD 613-533-6000 ext 7471 David.Maslove@kingstonhsc.ca
Contact: Tracy Boyd 613-533-6000 ext 2608 tracy.boyd@kingstonhsc.ca

Locations
Layout table for location information
Canada, Ontario
Kingston Health Sciences Centre
Kingston, Ontario, Canada, K7L 2V7
Contact: David Maslove, MD    613-549-6666 ext 7471    David.Maslove@kingstonhsc.ca   
Contact: Tracy Boyd    613-549-6666 ext 2608    Tracy.Boyd@kingstonhsc.ca   
Sponsors and Collaborators
Dr. David Maslove
Ironstone Professional Development
Layout table for additonal information
Responsible Party: Dr. David Maslove, Associate Professor, Queen's University
ClinicalTrials.gov Identifier: NCT04699942    
Other Study ID Numbers: 6031410
First Posted: January 7, 2021    Key Record Dates
Last Update Posted: January 7, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. David Maslove, Queen's University:
hypoxia
hypoxemia
oxygen delivery
COVID-19
rebreather circuit
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypoxia
Signs and Symptoms, Respiratory