Treatment of COVID-19 Positive/Negative Bangladeshi Adults With Severe Respiratory Complaints by a Locally Made bCPAP: Feasibility Study
- Conditions
- Acute Respiratory Distress SyndromeCovid19Severe Pneumonia
- Interventions
- Device: Adult bubble CPAP oxygen therapy device
- Registration Number
- NCT05158842
- Brief 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Bubble CPAP Oxygen Therapy Adult bubble CPAP oxygen therapy device Feasibility of Device
- Primary Outcome Measures
Name Time Method Optimising the treatment of COVID-19 positive/negative adults with severe pneumonia and/or ARDS in Bangladesh using an adaptive version of locally made Bubble CPAP: Feasibility study 17 weeks Barriers and operational challenges related to the introduction of adult bubble CPAP oxygen therapy.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Dhaka Hospital, ICDDR,B
🇧🇩Dhaka, Bangladesh
Dhaka Medical College Hospital
🇧🇩Dhaka, Bangladesh