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

Covid19 Clinical Trial

— OxyJet-CPAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04681859
• Other study ID #: BME-BUET-003
• Status: Completed
• Phase: N/A
• Start date: April 17, 2021
• Est. completion date: August 9, 2021

Study information

• Verified date: March 2022
• Source: Bangladesh University of Engineering and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: August 9, 2021
• Est. primary completion date: July 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Hypoxemia
• Hypoxia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Bangladesh	Dhaka Medical College	Dhaka

Sponsors (2)

Lead Sponsor	Collaborator
Bangladesh University of Engineering and Technology	Dhaka Medical College

Country where clinical trial is conducted

Bangladesh, 

Outcome

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