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

Covid19 Clinical Trial

— Adult-bCPAP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05158842
• Other study ID #: PR-20065
• Status: Completed
• Phase: N/A
• Start date: October 8, 2021
• Est. completion date: February 17, 2022

Study information

• Verified date: February 2022
• Source: International Centre for Diarrhoeal Disease Research, Bangladesh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• COVID-19
• Covid19
• Pneumonia
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Severe Pneumonia

Intervention

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: Adaptive version of nasal canula (nasal seal) A nasal canula with connecting circuit system 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.

Locations

Country	Name	City	State
Bangladesh	Dhaka Hospital, ICDDR,B	Dhaka
Bangladesh	Dhaka Medical College Hospital	Dhaka

Sponsors (3)

Lead Sponsor	Collaborator
International Centre for Diarrhoeal Disease Research, Bangladesh	Dhaka Medical College, University of Edinburgh

Country where clinical trial is conducted

Bangladesh, 

References & Publications (2)

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]

Outcome

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