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

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

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.

Study Overview

• Status: Completed
• Conditions: Covid19; Hypoxemia
• Intervention / Treatment: Device: High Flow Nasal Oxygen (HFNO) treatment; Device: Continuous Positive Airway Pressure (CPAP) therapy using OxyJet

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Bangladesh
  • Dhaka, Bangladesh, 1000
    • Dhaka Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: High Flow Nasal Oxygen (HFNO) treatment	Device: High Flow Nasal Oxygen (HFNO) treatment; 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.
Experimental: Continuous positive airway pressure (CPAP) therapy using OxyJet	Device: Continuous Positive Airway Pressure (CPAP) therapy using OxyJet; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Bangladesh University of Engineering and Technology
• Collaborators: Dhaka Medical College
• Investigators: Principal Investigator: Dr. Taufiq Hasan, PhD, Bangladesh University of Engineering and Technology; Principal Investigator: Dr. Robed Amin, MBBS, FCPS, Dhaka Medical College

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2021
• Primary Completion (Actual): July 9, 2021
• Study Completion (Actual): August 9, 2021

Study Registration Dates

• First Submitted: December 22, 2020
• First Submitted That Met QC Criteria: December 22, 2020
• First Posted (Actual): December 23, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2022
• Last Update Submitted That Met QC Criteria: March 24, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Signs and Symptoms, Respiratory; COVID-19; Hypoxia
• Other Study ID Numbers: BME-BUET-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No