Treatment of COVID-19 Positive/Negative Bangladeshi Adults With Severe Respiratory Complaints by a Locally Made bCPAP: Feasibility Study
Condition: Severe Pneumonia; Acute Respiratory Distress Syndrome; Covid19
MeSH terms: COVID-19; Pneumonia; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
Study type: Interventional

Summary: 
      Low and middle-income countries (LMICs) urgently need cost-effective adaptive technologies to
      provide CPAP. The lead investigator has designed a device that has already been approved by
      the Directorate General of Drug Administration (DGDA), Government of the People's Republic of
      Bangladesh.

      The design of the nasal seal was comfortable and well tolerated by all the participants.
      Patients were told about some mild discomfort at higher delivered pressures (14 or 15 cm
      PEEP), consistent with pressurised nasal delivery by similar devices.

      The safety phase has been initiated since 1st November 2020 and ended in April 2021. One
      patient withdrew from the study but none of them developed any adverse events.

      The feasibility phase started at the end of September 2021.

      Objectives:

        1. To evaluate the barriers and operational challenges related to the introduction of adult
           bubble CPAP oxygen therapy

        2. To evaluate the acceptability of introducing adult bubble CPAP in tertiary level
           hospitals of Bangladesh
    

Detailed description: 
      Low and middle-income countries (LMICs) urgently need cost-effective adaptive technologies to
      provide CPAP. The lead investigator has proved that a low cost, locally made bCPAP device is
      capable of reducing mortality in children, Its components are (a) an interface; nasal seal,
      (b) oxygen delivery piping, connectors and nasal cannula, (c) appropriately sized transparent
      plastic bottles (containing sterilized water). The device and its components are already
      being approved by the Directorate General of Drug Administration (DGDA), Government of the
      People's Republic of Bangladesh. Adapting this technology, if safe and scaled up, could
      possibly decrease the need for mechanical ventilation and subsequently averting deaths among
      adult COVID-19 patients.

      The design of the nasal seal was comfortable and well tolerated by all the participants.
      Patients were told about some mild discomfort at higher delivered pressures (14 or 15 cm
      PEEP), consistent with pressurised nasal delivery by similar devices. No additional adverse
      events such as trauma/injury, erosion, bruise, bleeding, obstruction, breathlessness,
      pneumothorax, pneumomediastinum, abdominal distension during and after the trial were
      reported.

      The safety phase has been initiated since 1st November 2020 and ended in April 2021. One
      patient withdrew from the study but none of them developed any adverse events.

      The feasibility phase started at the end of September 2021.

      Objectives:

        1. To evaluate the barriers and operational challenges related to the introduction of adult
           bubble CPAP oxygen therapy

        2. To evaluate the acceptability of introducing adult bubble CPAP in tertiary level
           hospitals of Bangladesh
    

Intervention name(s): Adult bubble CPAP oxygen therapy device
Intervention type(s): Device
Intervention description(s): In Bubble CPAP, pressurized oxygen from an oxygen cylinder is delivered to the patient. Adjusting the height of the water column above the exit of the tube can regulate the pressure in the system and the amount of CPAP delivered to the patient. Oxygen is delivered by a successfully tested, silicon-based, ergonomically designed adaptive version of nasal canula (nasal seal) inserted into the nostril of a patient.
The components are:
Adaptive version of nasal canula (nasal seal)
A nasal canula with connecting circuit system
Water-filled bottle with marking water pressure from10 to15 L/min.
Oxygen cylinder, central distribution through pipelines or by oxygen concentrator will be used as an oxygen source.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Feasibility; COVID-19; Bubble CPAP; Acute Respiratory Distress Syndrome; Severe Pneumonia