Clinical trial NCT05158842: Treatment of COVID-19 Positive/Negative Bangladeshi Adults With Severe Respiratory Complaints by a Locally Made bCPAP: Feasibility Study
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe Pneumonia
Acute Respiratory Distress Syndrome
Covid19
Keywords: Feasibility
COVID-19
Bubble CPAP
Acute Respiratory Distress Syndrome
Severe Pneumonia
Lead sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh
Sponsor class: OTHER
Collaborators: name: Dhaka Medical College
name: University of Edinburgh
First posted: 2021-12-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 17 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: Dhaka Hospital, ICDDR,B
city: Dhaka
country: Bangladesh
facility: Dhaka Medical College Hospital
Study officials:
affiliation: International Centre for Diarrhoeal Disease Research, Bangladesh
name: Mohammod J Chisti
role: PRINCIPAL_INVESTIGATOR
References:
citation: WHO. Clinical management of severe acute respiratory infection (SARI) when COVID-19 disease is suspected. Interim guidance, 13 March 2020. 2020 [1-21]
citation: 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.