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

NCT05158842 | Completed DMC

• 1 other identifier: PR-20065
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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

Conditions

Severe Pneumonia; Acute Respiratory Distress Syndrome; Covid19

Keywords

Feasibility; COVID-19; Bubble CPAP; Acute Respiratory Distress Syndrome; Severe Pneumonia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Bubble CPAP Oxygen Therapy

OTHER

Feasibility of Device

Device: Adult bubble CPAP oxygen therapy device

Interventions

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: 1. Adaptive version of nasal canula (nasal seal) 2. A nasal canula with connecting circuit system 3. 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.

Bubble CPAP Oxygen Therapy

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Staff:
• For Focus Group Discussions, physicians and nurses who do not provide written informed consent will be excluded.

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• Dhaka Medical College: collaborator
• University of Edinburgh: collaborator

Study Sites (2)

Dhaka Hospital, ICDDR,B

Dhaka, 1212, Bangladesh

Location

Dhaka Medical College Hospital

Dhaka, Bangladesh

Location

Related Publications (2)

• WHO. Clinical management of severe acute respiratory infection (SARI) when COVID-19 disease is suspected. Interim guidance, 13 March 2020. 2020 [1-21]

  BACKGROUND

• 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.

  PMID: 26296950 RESULT

MeSH Terms

Conditions

Pneumonia; Respiratory Distress Syndrome; COVID-19

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Study Officials

• Mohammod J Chisti

  International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: December 15, 2021
• Study Start: October 8, 2021
• Primary Completion: February 17, 2022
• Study Completion: February 17, 2022
• Last Updated: August 25, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

BA (2)