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

NCT04681859 | Completed DMC

• 1 other identifier: BME-BUET-003
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Covid19; Hypoxemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Recovery of the patient

  30 days

• Death or need of intubation

  10 days

• Oxygen toxicity or other adverse events

  10 days

Study Arms (2)

High Flow Nasal Oxygen (HFNO) treatment

ACTIVE COMPARATOR

Device: High Flow Nasal Oxygen (HFNO) treatment

Continuous positive airway pressure (CPAP) therapy using OxyJet

EXPERIMENTAL

Device: Continuous Positive Airway Pressure (CPAP) therapy using OxyJet

Interventions

High Flow Nasal Oxygen (HFNO) treatment DEVICE

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.

High Flow Nasal Oxygen (HFNO) treatment

Continuous Positive Airway Pressure (CPAP) therapy using OxyJet DEVICE

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.

Continuous positive airway pressure (CPAP) therapy using OxyJet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Severely hypoxemic patients (SpO2≤85%)
• Patients with low respiratory drive or requiring cardiopulmonary resuscitation
• Patients with contraindications for CPAP
• Pregnant status
• Age \> 65 years

Sponsors & Collaborators

• Bangladesh University of Engineering and Technology: lead
• Dhaka Medical College: collaborator

Study Sites (1)

Dhaka Medical College

Dhaka, 1000, Bangladesh

Location

MeSH Terms

Conditions

COVID-19; Hypoxia

Interventions

Therapeutics; Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Respiratory Therapy

Study Officials

• Dr. Taufiq Hasan, PhD

  Bangladesh University of Engineering and Technology

  PRINCIPAL INVESTIGATOR

• Dr. Robed Amin, MBBS, FCPS

  Dhaka Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: December 23, 2020
• Study Start: April 17, 2021
• Primary Completion: July 9, 2021
• Study Completion: August 9, 2021
• Last Updated: March 25, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)