Evaluation of a Low-cost CPAP Device on Hospitalized COVID-19 Patients

Study Overview
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Brief Summary
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The aim of this study is to evaluate the preliminary safety and performance of a low-cost locally-made Venturi-based Non-invasive Positive Pressure Ventilator (NIPPV) device for hypoxemic COVID-19 patients. The device administers Continuous Positive Airway Pressure (CPAP) therapy using the jet-mixing or Venturi effect to increase the volume flow rate of oxygenated air from a pressurized cylinder by entraining the atmospheric air. To provide CPAP therapy, this high flow of oxygenated air is delivered to the patient via a low-cost non-vented mask with a tight seal with a High-Efficiency Particulate Air (HEPA) filter connected to the exhalation limb. The tight seal and HEPA filter ensures a minimal risk of aerosol generation and thus the device can be used without a negative pressure room. The system consists of the developed Venturi-based flow-generator, a standard 22mm breathing tube, a standard Y-connector, a non-vented CPAP mask (e.g., snorkel mask, helmet), a HEPA filter, and a Positive End Expiratory Pressure (PEEP) valve. The bench-top testing of the device is done in the laboratories of BUET and was verified that the device performs within the CPAP guidelines provided by the Medicines and Healthcare products Regulatory Agency (MHRA), UK. This study aims to assess the safety of and efficacy of the device in three different steps: (1) design validation, (2) clinical feasibility and (3) pilot clinical trial for safety and efficacy evaluation. Only if the device successfully passes the parts 1 and 2, the investigators will proceed to the final clinical trial in step 3. In this final step, the investigators aim to conduct a randomized controlled trial (RCT) evaluating for non-inferiority of the CPAP intervention compared to standard HFNO treatment. The number of ventilator-free days will be used as the primary outcome for efficacy, while patient recovery, death, or need of intubation and other adverse events will be used as secondary outcomes.

Official Title
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Safety and Efficacy Evaluation of a Low-cost CPAP Device for Hypoxemic COVID-19 Patients: A Pilot Study

Conditions
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Covid19, Hypoxemia

Intervention / Treatment
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* Device: High Flow Nasal Oxygen (HFNO) treatment
* Device: Continuous Positive Airway Pressure (CPAP) therapy using OxyJet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Confirmed or suspected COVID-19 patient (by RT-PCR) having severe pneumonia and hypoxemia (SpO2 ≤90%) who did not respond to standard oxygen therapy (non-rebreather mask on 15L/min at 100% FiO2). Exclusion Criteria: Severely hypoxemic patients (SpO2≤85%) Patients with low respiratory drive or requiring cardiopulmonary resuscitation Patients with contraindications for CPAP Pregnant status Age > 65 years

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High Flow Nasal Oxygen (HFNO) treatment<br> | Device: High Flow Nasal Oxygen (HFNO) treatment<br>* Administration of High Flow Nasal Oxygen (HFNO) to patients who did not respond to standard low-flow oxygen therapy (non-rebreather mask on 15L/min). Adjust flow-rate and FiO2 as per standard HFNO treatment protocol.<br>|
| Experimental: Continuous positive airway pressure (CPAP) therapy using OxyJet<br> | Device: Continuous Positive Airway Pressure (CPAP) therapy using OxyJet<br>* Administer CPAP to patients who did not respond to standard low-flow oxygen therapy (non-rebreather mask on 15L/min). CPAP initiated with FiO2 at 40% and a 10cm PEEP. Titrate PEEP to 15 cm if required. Deliver additional oxygen via secondary port if a higher FiO2 is required.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of ventilator-free days | The total number of days the patient was able to avoid being placed under a mechanical ventilator. | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery of the patient | The event that the patient has recovered and released from the hospital within 30 days. | 30 days | 
| Death or need of intubation | The event that the patient dies or requires to be placed under a mechanical ventilator. | 10 days | 
| Oxygen toxicity or other adverse events | Oxygen toxicity or other adverse event rating according to the CTCAE scale (1-5) | 10 days |