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

International Centre for Diarrhoeal Disease Research (icddr,b)

Status

Completed

Conditions

Acute Respiratory Distress Syndrome

Covid19

Severe Pneumonia

Treatments

Device: Adult bubble CPAP oxygen therapy device

Study type

Interventional

Funder types

Other

Identifiers

NCT05158842

PR-20065

Details and patient eligibility

About

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 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:

To evaluate the barriers and operational challenges related to the introduction of adult bubble CPAP oxygen therapy
To evaluate the acceptability of introducing adult bubble CPAP in tertiary level hospitals of Bangladesh

Full 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:

To evaluate the barriers and operational challenges related to the introduction of adult bubble CPAP oxygen therapy
To evaluate the acceptability of introducing adult bubble CPAP in tertiary level hospitals of Bangladesh

Enrollment

20 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.