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

Ashley R Bjorklund, Beatrice Odongkara Mpora, Marie E Steiner, Gwenyth Fischer, Cynthia S Davey, Tina M Slusher

Research output: Contribution to journalArticle

2 Citations (Scopus)

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 O2sat 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.

Original languageEnglish (US)
Pages (from-to)160-167
Number of pages8
JournalPaediatrics and International Child Health
Volume39
Issue number3
DOIs
StatePublished - Jul 3 2019

Fingerprint

Continuous Positive Airway Pressure
Ear
Safety
Equipment and Supplies
Nose
Uganda
Mortality
Respiratory Rate
Clinical Trials
Newborn Infant
Prospective Studies
Pediatrics
Oxygen

Keywords

  • ACU, acute care unit
  • BUBBLES, bCPAP used beyond babies in low economic settings
  • Bubble continuous positive airway pressure
  • CPAP, continuous positive airway pressure
  • LMIC, low- and middle-income countries
  • OR, odds ratio
  • Osat, oxygen saturation
  • RR, respiratory rate
  • SD, standard deviation
  • SEAL-bCPAP, simplified ear-plug adapted low-cost bCPAP
  • TAL score, modified TAL clinical score
  • bCPAP, bubble continuous positive airway pressure
  • child health
  • cmHO, cm of water
  • device innovations
  • global health
  • international health
  • low- and middle-income countries
  • respiratory support

PubMed: MeSH publication types

  • Journal Article

Cite this

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title = "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",
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 O2sat 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.",
keywords = "ACU, acute care unit, BUBBLES, bCPAP used beyond babies in low economic settings, Bubble continuous positive airway pressure, CPAP, continuous positive airway pressure, LMIC, low- and middle-income countries, OR, odds ratio, Osat, oxygen saturation, RR, respiratory rate, SD, standard deviation, SEAL-bCPAP, simplified ear-plug adapted low-cost bCPAP, TAL score, modified TAL clinical score, bCPAP, bubble continuous positive airway pressure, child health, cmHO, cm of water, device innovations, global health, international health, low- and middle-income countries, respiratory support",
author = "Bjorklund, {Ashley R} and {Odongkara Mpora}, Beatrice and Steiner, {Marie E} and Gwenyth Fischer and Davey, {Cynthia S} and Slusher, {Tina M}",
year = "2019",
month = "7",
day = "3",
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language = "English (US)",
volume = "39",
pages = "160--167",
journal = "Paediatrics and international child health",
issn = "2046-9047",
publisher = "Maney Publishing",
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TY - JOUR

T1 - Use of a modified bubble continuous positive airway pressure (bCPAP) device for children in respiratory distress in low- and middle-income countries

T2 - a safety study

AU - Bjorklund, Ashley R

AU - Odongkara Mpora, Beatrice

AU - Steiner, Marie E

AU - Fischer, Gwenyth

AU - Davey, Cynthia S

AU - Slusher, Tina M

PY - 2019/7/3

Y1 - 2019/7/3

N2 - 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 O2sat 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.

AB - 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 O2sat 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.

KW - ACU, acute care unit

KW - BUBBLES, bCPAP used beyond babies in low economic settings

KW - Bubble continuous positive airway pressure

KW - CPAP, continuous positive airway pressure

KW - LMIC, low- and middle-income countries

KW - OR, odds ratio

KW - Osat, oxygen saturation

KW - RR, respiratory rate

KW - SD, standard deviation

KW - SEAL-bCPAP, simplified ear-plug adapted low-cost bCPAP

KW - TAL score, modified TAL clinical score

KW - bCPAP, bubble continuous positive airway pressure

KW - child health

KW - cmHO, cm of water

KW - device innovations

KW - global health

KW - international health

KW - low- and middle-income countries

KW - respiratory support

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U2 - 10.1080/20469047.2018.1474698

DO - 10.1080/20469047.2018.1474698

M3 - Article

C2 - 29912645

AN - SCOPUS:85048797577

VL - 39

SP - 160

EP - 167

JO - Paediatrics and international child health

JF - Paediatrics and international child health

SN - 2046-9047

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ER -