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

August 24, 2022 updated by: International Centre for Diarrhoeal Disease Research, Bangladesh

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bangladesh
      • Dhaka, Bangladesh
        • Dhaka Medical College Hospital
      • Dhaka, Bangladesh, 1212
        • Dhaka Hospital, ICDDR,B

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Bubble CPAP Oxygen Therapy
Feasibility of Device
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:

  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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 17 weeks
Barriers and operational challenges related to the introduction of adult bubble CPAP oxygen therapy.
17 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

International Centre for Diarrhoeal Disease Research, Bangladesh

Collaborators

University of Edinburgh
Dhaka Medical College

Investigators

  • Principal Investigator: Mohammod J Chisti, International Centre for Diarrhoeal Disease Research, Bangladesh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 8, 2021

Primary Completion (Actual)

February 17, 2022

Study Completion (Actual)

February 17, 2022

Study Registration Dates

First Submitted

March 29, 2021

First Submitted That Met QC Criteria

December 14, 2021

First Posted (Actual)

December 15, 2021

Study Record Updates

Last Update Posted (Actual)

August 25, 2022

Last Update Submitted That Met QC Criteria

August 24, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR-20065

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Covid19

Clinical Trials on Adult bubble CPAP oxygen therapy device

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kosovo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe