Pilot Study to Evaluate the Revoxa™ System in Hypoxic Patients

NCT04699942 | Completed

• 1 other identifier: 6031410
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoxemia

Keywords

hypoxia; hypoxemia; oxygen delivery; COVID-19; rebreather circuit

Outcome Measures

Primary Outcomes (1)

• Oxygen flow required to achieve SpO2 >96%.

  Oxygen flow required to achieve SpO2 \>96%.

  Baseline to 20 minutes

Secondary Outcomes (4)

• Average oxygen consumption

  Baseline to 20 minutes

• Peak SpO2

  Baseline to 20 minutes

• Patient-reported dyspnea (Modified Borg Scale)

  Baseline to 20 minutes

• Patient-reported comfort (Visual Analogue Scale)

  Baseline to 20 minutes

Study Arms (2)

Conventional

ACTIVE COMPARATOR

Conventional low-flow Oxygen Delivery

Device: Conventional (low flow) oxygen delivery via nasal cannula

Revoxa

EXPERIMENTAL

Oxygen Delivery via Revoxa Oxygen Rebreather Device

Device: Revoxa Oxygen Rebrearther

Interventions

Conventional (low flow) oxygen delivery via nasal cannula DEVICE

Conventional (low flow) oxygen delivery via nasal cannula or face mask for 20 minutes

Conventional

Revoxa Oxygen Rebrearther DEVICE

Oxygen delivery via Revoxa Oxygen Rebreather device for 20 minutes

Revoxa

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Dr. David Maslove: lead
• Ironstone Professional Development: collaborator

Study Sites (1)

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada

Location

MeSH Terms

Conditions

Hypoxia; COVID-19

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 5, 2021
• First Posted: January 7, 2021
• Study Start: February 1, 2021
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)