Severe PneumoniaAdult-bCPAPNCT05158842
Treatment of COVID-19 Positive/Negative Bangladeshi Adults With Severe Respiratory Complaints by a Locally Made bCPAP: Feasibility Study
A study testing Adult bubble CPAP oxygen therapy device in people with Severe Pneumonia and Acute Respiratory Distress Syndrome, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 2 sites in Bangladesh.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Severe Pneumonia, Acute Respiratory Distress Syndrome, Covid19
- What is being tested?
- Adult bubble CPAP oxygen therapy device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesBangladesh
- Study dates
- 8 Oct 2021to 17 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Bangladesh2 sites
Dhaka Hospital, ICDDR,B
Dhaka, 1212
Dhaka Medical College Hospital
Dhaka
About this study
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
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.
Read more
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
Read the 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:
- 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
- Being tested
- Adult bubble CPAP oxygen therapy device
- Keywords
- Feasibility, COVID-19, Bubble CPAP, Acute Respiratory Distress Syndrome, Severe Pneumonia
- Medical subject headings
- Pneumonia, Respiratory Distress Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adult bubble CPAP oxygen therapy deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Bubble CPAP Oxygen Therapy | Other | Feasibility of Device Receives: Device: Adult bubble CPAP oxygen therapy device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 17 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start8 Oct 2021
- Primary completion17 Feb 2022
- Study completion17 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Severe PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Sponsor type
- University, hospital or other
- Collaborators
- Dhaka Medical College, University of Edinburgh
- Responsible party
- Sponsor
- Investigators
- Mohammod J Chisti, Principal investigator, International Centre for Diarrhoeal Disease Research, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05158842
- Sponsor's protocol ID
- PR-20065
- Acronym
- Adult-bCPAP
- Status last verified
- Feb 2022
- First submitted
- 29 Mar 2021
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
WHO. Clinical management of severe acute respiratory infection (SARI) when COVID-19 disease is suspected. Interim guidance, 13 March 2020. 2020 [1-21]
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.
PubMed 26296950
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05158842
- Acronym / sponsor ID
- Adult-bCPAP / PR-20065
- Keywords
- Feasibility, COVID-19, Bubble CPAP, Acute Respiratory Distress Syndrome, Severe Pneumonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, BangladeshUniversity, hospital or other
- Collaborators
- Dhaka Medical College, University of Edinburgh
- Study start
- 8 Oct 2021 (actual)
- Primary completion
- 17 Feb 2022 (actual)
- Study completion
- 17 Feb 2022 (actual)
- First posted
- 15 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
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:
- 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
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bubble CPAP Oxygen Therapy | Other | Device: Adult bubble CPAP oxygen therapy deviceFeasibility of Device |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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 (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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adult bubble CPAP oxygen therapy deviceIn 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. | Device | Bubble CPAP Oxygen Therapy |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
- BackgroundWHO. Clinical management of severe acute respiratory infection (SARI) when COVID-19 disease is suspected. Interim guidance, 13 March 2020. 2020 [1-21]
- Results publication: PubMed 26296950Chisti 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammod J Chisti principal investigator
International Centre for Diarrhoeal Disease Research, Bangladesh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adult bubble CPAP oxygen therapy device in people with Severe Pneumonia and Acute Respiratory Distress Syndrome, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 2 sites in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05158842, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2022.