NCT05158842

Treatment of COVID-19 Positive/Negative Bangladeshi Adults With Severe Respiratory Complaints by a Locally Made bCPAP: Feasibility Study

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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

Conditions

• Severe Pneumonia
• Acute Respiratory Distress Syndrome
• Covid19

Interventions

Type	Name	Description
DEVICE	Adult bubble CPAP oxygen therapy device	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: 1. Adaptive version of nasal canula (nasal seal) 2. A nasal canula with connecting circuit system 3. 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.

Timeline

• Start date: 2021-10-08
• Primary completion: 2022-02-17
• Completion: 2022-02-17
• First posted: 2021-12-15
• Last updated: 2022-08-25

Locations

2 sites across 1 country: Bangladesh