An observational study in Feasibility, sponsored by International Centre for Diarrhoeal Disease Research, Bangladesh. Completed at 2 sites in Bangladesh. Open to participants aged 2 Months to 24 Months. Per ClinicalTrials.gov, last updated 2022-02-15.
Sponsored by International Centre for Diarrhoeal Disease Research, Bangladesh · Observational
Background: Feasibility and acceptability of bubble continuous positive airway pressure (CPAP) were not evaluated in childhood severe pneumonia in developing countries at a larger scale.
Objective:
Methodology:
Feasibility/demonstration phase will be done as an internal pilot in 2 hospitals. Current treatment practice, facilities, and operational challenges will be evaluated for the introduction, clinical use and maintenance of bubble CPAP.
Outcome:
Number of children to be enrolled: 20 children in 2 hospitals as an internal pilot (i.e. 10 in each hospital)
Main inclusion criteria: Age between 2 months and 24 months with severe pneumonia and hypoxemia and guardian/parent gives written informed consent to participate in the study.
Statistical Analysis: For feasibility and acceptability study, a descriptive analysis will be performed.
Study duration: 44 months
2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.
This study's enrollment of 20 is below the median of 203 across 688 observational studies indexed under Pneumonia.
Browse Pneumonia studies →International Centre for Diarrhoeal Disease Research, Bangladesh is the lead sponsor of 197 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Children aged 2-24 months having hypoxaemia in pneumonia (Pneumonia defined by WHO criteria)
Staff:
Children for assessment of hypoxaemia in pneumonia and outcomes:
Children receiving bubble CPAP:
EXCLUSION CRITERIA
Hospital staff:
o There will be no exclusion criteria
Children for assessment of hypoxaemia in pneumonia and outcomes, and children receiving bubble CPAP:
Oxygen will be delivered by Bubble CPAP device, which will have three components: 1. Continuous gas flow into the circuit: The gas flow rate required to generate CPAP is usually 5-10 L/min. 2. A nasal interface connecting the child's airway with the circuit: short nasal prongs are generally used to deliver nasal CPAP. They must be carefully fitted to minimize leakage of air (otherwise, CPAP will not be achieved) . 3. An expiratory arm with the distal end submerged in water to generate end-expiratory pressure: in bubble CPAP, the positive pressure is maintained by placing the far end of the expiratory tubing in water. The pressure is adjusted by altering the depth of the tube under the surface of the water.
Device: Bubble CPAP oxygen delivery device
In Bubble CPAP, pressurized oxygen from an oxygen cylinder is delivered to the nasopharynx of the baby. An underwater tube (expiratory arm) that acts as a blow off valve is interposed between the oxygen source and the baby. 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 baby. The constant bubbling of gas through the blow off mechanism delivers the bubbling CPAP effect. Oxygen may be delivered by nasal prongs inserted into the nostril of child. The system has three components: 1. Continuous gas flow into the circuit: The gas flow rate required to generate CPAP is usually 5-10 L/min. 2. A nasal interface connecting the child's airway with the circuit: 3. An expiratory arm with the distal end submerged in water to generate end-expiratory pressure. The source of oxygen will be either an oxygen concentrator or cylinder, central distribution through pipelines.
The structural, functional and operational challenges will be described
Human resources, Supply chain, logistics equipment maintenance, power failure, disconnection of oxygen with local complications will be identified.
Time frame: 44 month
To have bubble CPAP training materials that can be delivered cheaply and repeatedly to a level of comprehension of staff providing care to children with pneumonia in district general hospitals in Bangladesh
The training module, Standard Operating Procedure, treatment algorithm will be provided to the hospital staff. Hands-on training will be done.
Time frame: 44 month
A quantitative analysis of the incidence of hypoxaemia among hospitalised children with severe pneumonia, current management practices and clinical outcomes
Prevalence, management, mortality, referral, discharge, hospital stay, oxygen therapy duration of severe pneumonia cases will be identified.
Time frame: 44 month
Feasibility and acceptability of introducing bubble CPAP
Challenges related to the introduction of bCPAP, enrollment, patient management with follow-up recording, human resources, respiratory support will be identified.
Time frame: 44 month
Plan to share: No — After the end of the study, data will be analyzed as ter the defined data analysis plan on the protocol. Study results will be shared with other researchers by journal publications, conferences proceedings and dissemination programs
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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International Centre for Diarrhoeal Disease Research, Bangladesh