NCT04681859: OxyJet-CPAP

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

Completed NA Last updated 25 March 2022

What this trial tests

NA trial testing High Flow Nasal Oxygen (HFNO) treatment in Covid19 in 45 participants. Completed in 9 August 2021.

Timeline

17 April 2021

Primary endpoint
9 July 2021

9 August 2021

Quick facts

Lead sponsor	Bangladesh University of Engineering and Technology
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	45
Start date	17 April 2021
Primary completion	9 July 2021
Estimated completion	9 August 2021
Sites	1 location across Bangladesh

Drugs / interventions tested

• High Flow Nasal Oxygen (HFNO) treatment
• Continuous Positive Airway Pressure (CPAP) therapy using OxyJet

Conditions studied

• Covid19 — all drugs for Covid19 →
• Hypoxemia — all drugs for Hypoxemia →

Sponsor

Bangladesh University of Engineering and Technology

Who can join

Adults 18 to 65, any sex, with Covid19 or Hypoxemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Comparison of Low-cost, Electricity-free, CPAP (OXYJET) with High-Flow Nasal Cannula Treatment outside Critical Care: A Randomized Clinical Trial
   Hasan T, Ahmed MK, Alman KA, Rashid M, et al · · 2023 · DOI 10.21203/rs.3.rs-3279902/v1