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| Name | Class |
|---|---|
| Dhaka Medical College | OTHER |
| University of Edinburgh | OTHER |
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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bubble CPAP Oxygen Therapy | Other | Feasibility of Device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adult bubble CPAP oxygen therapy device | 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:
Oxygen cylinder, central distribution through pipelines or by oxygen concentrator will be used as an oxygen source. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Barriers and operational challenges related to the introduction of adult bubble CPAP oxygen therapy. | 17 weeks |
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INCLUSION CRITERIA
Adults for assessment:
Staff:
EXCLUSION CRITERIA
Adults for assessment:
Staff:
• For Focus Group Discussions, physicians and nurses who do not provide written informed consent will be excluded.
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| Name | Affiliation | Role |
|---|---|---|
| Mohammod J Chisti | International Centre for Diarrhoeal Disease Research, Bangladesh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dhaka Hospital, ICDDR,B | Dhaka | 1212 | Bangladesh | |||
| Dhaka Medical College Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | WHO. Clinical management of severe acute respiratory infection (SARI) when COVID-19 disease is suspected. Interim guidance, 13 March 2020. 2020 [1-21] | ||
| 26296950 | Result | Chisti MJ, Salam MA, Smith JH, Ahmed T, Pietroni MA, Shahunja KM, Shahid AS, Faruque AS, Ashraf H, Bardhan PK, Sharifuzzaman, Graham SM, Duke T. Bubble continuous positive airway pressure for children with severe pneumonia and hypoxaemia in Bangladesh: an open, randomised controlled trial. Lancet. 2015 Sep 12;386(9998):1057-65. doi: 10.1016/S0140-6736(15)60249-5. Epub 2015 Aug 19. |
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|
| Dhaka |
| Bangladesh |
| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D012128 | Respiratory Distress Syndrome |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D011024 | Pneumonia, Viral |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
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