Covid19 Clinical Trial
— Adult-bCPAPOfficial title:
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
Verified date | February 2022 |
Source | International Centre for Diarrhoeal Disease Research, Bangladesh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 20 |
Est. completion date | February 17, 2022 |
Est. primary completion date | February 17, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 64 Years |
Eligibility | INCLUSION CRITERIA Adults for assessment: - Male or female - RT-PCR positive or negative for COVID-19 - Aged 18-64 years, with severe pneumonia and hypoxemia (SpO2 < 90%). - Willing and able to provide written informed consent. Staff: - Staff (physicians and nurses) who are engaged in the medicine ward, HDU and COVID ward of Dhaka Hospital of icddr,b and Dhaka Medical College Hospital. - Staff who agree to participate and give written informed consent. EXCLUSION CRITERIA Adults for assessment: - Patients will not be included in the study if they will not have adequate respiratory drive such as gasping respiration or requiring cardiopulmonary resuscitation or - Known to have life threatening heart disease, - Status asthmaticus - Upper-airway obstruction - Patients with pneumonia/respiratory tract illness but without hypoxaemia or SpO2< 80% in room air even on prone position and chest physiotherapy - Pregnancy, nasal polyp and - Patients who are not willing or able to provide written informed consent. - Arterial blood gas analysis will be performed to check the exclusion criteria. Staff: • For Focus Group Discussions, physicians and nurses who do not provide written informed consent will be excluded. |
Country | Name | City | State |
---|---|---|---|
Bangladesh | Dhaka Hospital, ICDDR,B | Dhaka | |
Bangladesh | Dhaka Medical College Hospital | Dhaka |
Lead Sponsor | Collaborator |
---|---|
International Centre for Diarrhoeal Disease Research, Bangladesh | Dhaka Medical College, University of Edinburgh |
Bangladesh,
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 — View Citation
WHO. Clinical management of severe acute respiratory infection (SARI) when COVID-19 disease is suspected. Interim guidance, 13 March 2020. 2020 [1-21]
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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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