Use of a modified bubble continuous positive airway pressure (bCPAP) device for children in respiratory distress in low- and middle-income countries: a safety study
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Date
2018-06-18
Journal Title
Journal ISSN
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Publisher
Taylor & Francis
Abstract
Background: While bubble continuous positive airway pressure (bCPAP) is commonly used in
low- and middle-income countries (LMIC) to support neonates with respiratory distress, there
are limited non-invasive support options for non-neonatal children.
Aim: To demonstrate safety of a new device designed to support children during respiratory
distress in LMIC.
Methods: A paediatric bCPAP device was designed called SEAL-bCPAP (Simplified Ear-plug
Adapted-bCPAP). SEAL-bCPAP is constructed from inexpensive, easily obtainable materials. The
nasal prong interface was modified from previously described neonatal bCPAP set-ups using
commercial ear-plug material to improve nasal seal. A prospective interventional study was
conducted to evaluate safety in children with respiratory distress treated with SEAL-bCPAP.
Patients aged 30 days to 5 years presenting to a hospital in northern Uganda from July 2015
to June 2016 were screened. Those with moderate–severe respiratory distress and/or hypoxia
despite nasal cannula oxygen were eligible for study. Enrolled patients were supported with
SEAL-bCPAP until respiratory improvement or death. Complications attributable to SEAL-bCPAP
were recorded. Clinical outcomes were compared with historical control pre-trial data.
Results: Eighty-three of 87 enrolled patients were included in the final analysis. No patients had
significant SEAL-bCPAP complications. Five patients had mild complications which resolved
(four with nasal irritation and one with abdominal distention). Trial patients had significant
(P < 0.0001) improvement in their TAL score, respiratory rate and O2
sat after 2 h of SEAL-bCPAP.
Fifty-two of 64 patients (62.7%) with severe illness at Time1 did not have severe illness at Time2
(after 2 h of SEAL-bCPAP) (p < 0.0001). Unadjusted mortality rates were 12.2% (6/49) and 9.6%
(8/83), respectively, for pre-trial (historical control) and trial patients (p = 0.64); the study was not
powered to show efficacy.
Conclusions: The SEAL-bCPAP device is safe for treatment of respiratory distress in non-neonatal
children in LMIC. There is a trend toward decreased mortality that should be evaluated with
adequately powered clinical trials.
Abbreviations: ACU, acute care unit; bCPAP, bubble continuous positive airway pressure;
BUBBLES, bCPAP used beyond babies in low economic settings; cmH2
O, cm of water; CPAP,
continuous positive airway pressure; LMIC, low- and middle-income countries; OR, odds ratio;
O2
sat, oxygen saturation; RR, respiratory rate; SD, standard deviation; SEAL-bCPAP, simplified ear
plug adapted low-cost bCPAP; TAL score, modified TAL clinical score
Description
Keywords
Bubble continuous positive airway pressure, low- and middle-income countries, global health, respiratory support, international health, child health, device innovations
Citation
Ashley R. Bjorklund, Beatrice Odongkara Mpora, Marie E. Steiner, Gwenyth Fischer, Cynthia S. Davey & Tina M. Slusher (2019) Use of a modified bubble continuous positive airway pressure (bCPAP) device for children in respiratory distress in low- and middle income countries: a safety study, Paediatrics and International Child Health, 39:3, 160-167, DOI: 10.1080/20469047.2018.1474698