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

NCT05158842 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-08-25

No results posted yet for this study

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

Conditions

  • Severe Pneumonia
  • Acute Respiratory Distress Syndrome
  • Covid19

Interventions

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.

Sponsors & Collaborators

  • Dhaka Medical College

    collaborator OTHER

  • University of Edinburgh

    collaborator OTHER

  • International Centre for Diarrhoeal Disease Research, Bangladesh

    lead OTHER

Principal Investigators

  • Mohammod J Chisti · International Centre for Diarrhoeal Disease Research, Bangladesh

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-08
Primary Completion
2022-02-17
Completion
2022-02-17

Countries

  • Bangladesh

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05158842 on ClinicalTrials.gov