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Bubble continuous positive airway pressure for children with severe pneumonia and hypoxaemia in Bangladesh: an open, randomised controlled trial

Summary Background In developing countries, mortality in children with very severe pneumonia is high, even with the provision of appropriate antibiotics, standard oxygen therapy, and other supportive care. We assessed whether oxygen therapy delivered by bubble continuous positive airway pressure (CP... Full description

Journal Title: The Lancet (British edition) 2015, Vol.386 (9998), p.1057-1065
Main Author: Chisti, Mohammod J, PhD
Other Authors: Salam, Mohammed A, MBBS , Smith, Jonathan H, FRCA , Ahmed, Tahmeed, Prof , Pietroni, Mark A C, Prof , Shahunja, K M, MBBS , Shahid, Abu S M S B, MBBS , Faruque, Abu S G, MPH , Ashraf, Hasan, MD , Bardhan, Pradip K, MD , Sharifuzzaman, MBBS , Graham, Stephen M, Prof , Duke, Trevor, Prof
Format: Electronic Article Electronic Article
Language: English
Subjects:
Quelle: Alma/SFX Local Collection
Publisher: England: Elsevier Ltd
ID: ISSN: 0140-6736
Link: https://www.ncbi.nlm.nih.gov/pubmed/26296950
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title: Bubble continuous positive airway pressure for children with severe pneumonia and hypoxaemia in Bangladesh: an open, randomised controlled trial
format: Article
creator:
  • Chisti, Mohammod J, PhD
  • Salam, Mohammed A, MBBS
  • Smith, Jonathan H, FRCA
  • Ahmed, Tahmeed, Prof
  • Pietroni, Mark A C, Prof
  • Shahunja, K M, MBBS
  • Shahid, Abu S M S B, MBBS
  • Faruque, Abu S G, MPH
  • Ashraf, Hasan, MD
  • Bardhan, Pradip K, MD
  • Sharifuzzaman, MBBS
  • Graham, Stephen M, Prof
  • Duke, Trevor, Prof
subjects:
  • Abridged Index Medicus
  • Bacterial pneumonia
  • Bangladesh
  • Children
  • Children & youth
  • Continuous positive airway pressure
  • Continuous Positive Airway Pressure - methods
  • Developing Countries
  • Female
  • Health aspects
  • Humans
  • Hypoxia
  • Hypoxia - microbiology
  • Hypoxia - therapy
  • Infant
  • Internal Medicine
  • Length of Stay - statistics & numerical data
  • Male
  • Mortality
  • Oxygen
  • Oxygen Inhalation Therapy - methods
  • Pneumonia
  • Pneumonia - complications
  • Pneumonia - therapy
  • Respiratory therapy
  • Treatment Outcome
  • United Kingdom
ispartof: The Lancet (British edition), 2015, Vol.386 (9998), p.1057-1065
description: Summary Background In developing countries, mortality in children with very severe pneumonia is high, even with the provision of appropriate antibiotics, standard oxygen therapy, and other supportive care. We assessed whether oxygen therapy delivered by bubble continuous positive airway pressure (CPAP) improved outcomes compared with standard low-flow and high-flow oxygen therapies. Methods This open, randomised, controlled trial took place in Dhaka Hospital of the International Centre for Diarrhoeal Disease Research, Bangladesh. We randomly assigned children younger than 5 years with severe pneumonia and hypoxaemia to receive oxygen therapy by either bubble CPAP (5 L/min starting at a CPAP level of 5 cm H2 O), standard low-flow nasal cannula (2 L/min), or high-flow nasal cannula (2 L/kg per min up to the maximum of 12 L/min). Randomisation was done with use of the permuted block methods (block size of 15 patients) and Fisher and Yates tables of random permutations. The primary outcome was treatment failure (ie, clinical failure, intubation and mechanical ventilation, death, or termination of hospital stay against medical advice) after more than 1 h of treatment. Primary and safety analyses were by intention to treat. We did two interim analyses and stopped the trial after the second interim analysis on Aug 3, 2013, as directed by the data safety and monitoring board. This trial is registered at ClinicalTrials.gov , number NCT01396759. Findings Between Aug 4, 2011, and July 17, 2013, 225 eligible children were recruited. We randomly allocated 79 (35%) children to receive oxygen therapy by bubble CPAP, 67 (30%) to low-flow oxygen therapy, and 79 (35%) to high-flow oxygen therapy. Treatment failed for 31 (14%) children, of whom five (6%) had received bubble CPAP, 16 (24%) had received low-flow oxygen therapy, and ten (13%) had received high-flow oxygen therapy. Significantly fewer children in the bubble CPAP group had treatment failure than in the low-flow oxygen therapy group (relative risk [RR] 0·27, 99·7% CI 0·07–0·99; p=0·0026). No difference in treatment failure was noted between patients in the bubble CPAP and those in the high-flow oxygen therapy group (RR 0·50, 99·7% 0·11–2·29; p=0·175). 23 (10%) children died. Three (4%) children died in the bubble CPAP group, ten (15%) children died in the low-flow oxygen therapy group, and ten (13%) children died in the high-flow oxygen therapy group. Children who received oxygen by bubble CPAP had significantly l
language: eng
source: Alma/SFX Local Collection
identifier: ISSN: 0140-6736
fulltext: fulltext
issn:
  • 0140-6736
  • 1474-547X
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titleBubble continuous positive airway pressure for children with severe pneumonia and hypoxaemia in Bangladesh: an open, randomised controlled trial
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creatorChisti, Mohammod J, PhD ; Salam, Mohammed A, MBBS ; Smith, Jonathan H, FRCA ; Ahmed, Tahmeed, Prof ; Pietroni, Mark A C, Prof ; Shahunja, K M, MBBS ; Shahid, Abu S M S B, MBBS ; Faruque, Abu S G, MPH ; Ashraf, Hasan, MD ; Bardhan, Pradip K, MD ; Sharifuzzaman, MBBS ; Graham, Stephen M, Prof ; Duke, Trevor, Prof
creatorcontribChisti, Mohammod J, PhD ; Salam, Mohammed A, MBBS ; Smith, Jonathan H, FRCA ; Ahmed, Tahmeed, Prof ; Pietroni, Mark A C, Prof ; Shahunja, K M, MBBS ; Shahid, Abu S M S B, MBBS ; Faruque, Abu S G, MPH ; Ashraf, Hasan, MD ; Bardhan, Pradip K, MD ; Sharifuzzaman, MBBS ; Graham, Stephen M, Prof ; Duke, Trevor, Prof
descriptionSummary Background In developing countries, mortality in children with very severe pneumonia is high, even with the provision of appropriate antibiotics, standard oxygen therapy, and other supportive care. We assessed whether oxygen therapy delivered by bubble continuous positive airway pressure (CPAP) improved outcomes compared with standard low-flow and high-flow oxygen therapies. Methods This open, randomised, controlled trial took place in Dhaka Hospital of the International Centre for Diarrhoeal Disease Research, Bangladesh. We randomly assigned children younger than 5 years with severe pneumonia and hypoxaemia to receive oxygen therapy by either bubble CPAP (5 L/min starting at a CPAP level of 5 cm H2 O), standard low-flow nasal cannula (2 L/min), or high-flow nasal cannula (2 L/kg per min up to the maximum of 12 L/min). Randomisation was done with use of the permuted block methods (block size of 15 patients) and Fisher and Yates tables of random permutations. The primary outcome was treatment failure (ie, clinical failure, intubation and mechanical ventilation, death, or termination of hospital stay against medical advice) after more than 1 h of treatment. Primary and safety analyses were by intention to treat. We did two interim analyses and stopped the trial after the second interim analysis on Aug 3, 2013, as directed by the data safety and monitoring board. This trial is registered at ClinicalTrials.gov , number NCT01396759. Findings Between Aug 4, 2011, and July 17, 2013, 225 eligible children were recruited. We randomly allocated 79 (35%) children to receive oxygen therapy by bubble CPAP, 67 (30%) to low-flow oxygen therapy, and 79 (35%) to high-flow oxygen therapy. Treatment failed for 31 (14%) children, of whom five (6%) had received bubble CPAP, 16 (24%) had received low-flow oxygen therapy, and ten (13%) had received high-flow oxygen therapy. Significantly fewer children in the bubble CPAP group had treatment failure than in the low-flow oxygen therapy group (relative risk [RR] 0·27, 99·7% CI 0·07–0·99; p=0·0026). No difference in treatment failure was noted between patients in the bubble CPAP and those in the high-flow oxygen therapy group (RR 0·50, 99·7% 0·11–2·29; p=0·175). 23 (10%) children died. Three (4%) children died in the bubble CPAP group, ten (15%) children died in the low-flow oxygen therapy group, and ten (13%) children died in the high-flow oxygen therapy group. Children who received oxygen by bubble CPAP had significantly lower rates of death than the children who received oxygen by low-flow oxygen therapy (RR 0·25, 95% CI 0·07–0·89; p=0·022). Interpretation Oxygen therapy delivered by bubble CPAP improved outcomes in Bangladeshi children with very severe pneumonia and hypoxaemia compared with standard low-flow oxygen therapy. Use of bubble CPAP oxygen therapy could have a large effect in hospitals in developing countries where the only respiratory support for severe childhood pneumonia and hypoxaemia is low-flow oxygen therapy. The trial was stopped early because of higher mortality in the low-flow oxygen group than in the bubble CPAP group, and we acknowledge that the early cessation of the trial reduces the certainty of the findings. Further research is needed to test the feasibility of scaling up bubble CPAP in district hospitals and to improve bubble CPAP delivery technology. Funding International Centre for Diarrhoeal Disease Research, Bangladesh, and Centre for International Child Health, University of Melbourne.
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languageeng
publisherEngland: Elsevier Ltd
subjectAbridged Index Medicus ; Bacterial pneumonia ; Bangladesh ; Children ; Children & youth ; Continuous positive airway pressure ; Continuous Positive Airway Pressure - methods ; Developing Countries ; Female ; Health aspects ; Humans ; Hypoxia ; Hypoxia - microbiology ; Hypoxia - therapy ; Infant ; Internal Medicine ; Length of Stay - statistics & numerical data ; Male ; Mortality ; Oxygen ; Oxygen Inhalation Therapy - methods ; Pneumonia ; Pneumonia - complications ; Pneumonia - therapy ; Respiratory therapy ; Treatment Outcome ; United Kingdom
ispartofThe Lancet (British edition), 2015, Vol.386 (9998), p.1057-1065
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0Chisti, Mohammod J, PhD
1Salam, Mohammed A, MBBS
2Smith, Jonathan H, FRCA
3Ahmed, Tahmeed, Prof
4Pietroni, Mark A C, Prof
5Shahunja, K M, MBBS
6Shahid, Abu S M S B, MBBS
7Faruque, Abu S G, MPH
8Ashraf, Hasan, MD
9Bardhan, Pradip K, MD
10Sharifuzzaman, MBBS
11Graham, Stephen M, Prof
12Duke, Trevor, Prof
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0Bubble continuous positive airway pressure for children with severe pneumonia and hypoxaemia in Bangladesh: an open, randomised controlled trial
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descriptionSummary Background In developing countries, mortality in children with very severe pneumonia is high, even with the provision of appropriate antibiotics, standard oxygen therapy, and other supportive care. We assessed whether oxygen therapy delivered by bubble continuous positive airway pressure (CPAP) improved outcomes compared with standard low-flow and high-flow oxygen therapies. Methods This open, randomised, controlled trial took place in Dhaka Hospital of the International Centre for Diarrhoeal Disease Research, Bangladesh. We randomly assigned children younger than 5 years with severe pneumonia and hypoxaemia to receive oxygen therapy by either bubble CPAP (5 L/min starting at a CPAP level of 5 cm H2 O), standard low-flow nasal cannula (2 L/min), or high-flow nasal cannula (2 L/kg per min up to the maximum of 12 L/min). Randomisation was done with use of the permuted block methods (block size of 15 patients) and Fisher and Yates tables of random permutations. The primary outcome was treatment failure (ie, clinical failure, intubation and mechanical ventilation, death, or termination of hospital stay against medical advice) after more than 1 h of treatment. Primary and safety analyses were by intention to treat. We did two interim analyses and stopped the trial after the second interim analysis on Aug 3, 2013, as directed by the data safety and monitoring board. This trial is registered at ClinicalTrials.gov , number NCT01396759. Findings Between Aug 4, 2011, and July 17, 2013, 225 eligible children were recruited. We randomly allocated 79 (35%) children to receive oxygen therapy by bubble CPAP, 67 (30%) to low-flow oxygen therapy, and 79 (35%) to high-flow oxygen therapy. Treatment failed for 31 (14%) children, of whom five (6%) had received bubble CPAP, 16 (24%) had received low-flow oxygen therapy, and ten (13%) had received high-flow oxygen therapy. Significantly fewer children in the bubble CPAP group had treatment failure than in the low-flow oxygen therapy group (relative risk [RR] 0·27, 99·7% CI 0·07–0·99; p=0·0026). No difference in treatment failure was noted between patients in the bubble CPAP and those in the high-flow oxygen therapy group (RR 0·50, 99·7% 0·11–2·29; p=0·175). 23 (10%) children died. Three (4%) children died in the bubble CPAP group, ten (15%) children died in the low-flow oxygen therapy group, and ten (13%) children died in the high-flow oxygen therapy group. Children who received oxygen by bubble CPAP had significantly lower rates of death than the children who received oxygen by low-flow oxygen therapy (RR 0·25, 95% CI 0·07–0·89; p=0·022). Interpretation Oxygen therapy delivered by bubble CPAP improved outcomes in Bangladeshi children with very severe pneumonia and hypoxaemia compared with standard low-flow oxygen therapy. Use of bubble CPAP oxygen therapy could have a large effect in hospitals in developing countries where the only respiratory support for severe childhood pneumonia and hypoxaemia is low-flow oxygen therapy. The trial was stopped early because of higher mortality in the low-flow oxygen group than in the bubble CPAP group, and we acknowledge that the early cessation of the trial reduces the certainty of the findings. Further research is needed to test the feasibility of scaling up bubble CPAP in district hospitals and to improve bubble CPAP delivery technology. Funding International Centre for Diarrhoeal Disease Research, Bangladesh, and Centre for International Child Health, University of Melbourne.
subject
0Abridged Index Medicus
1Bacterial pneumonia
2Bangladesh
3Children
4Children & youth
5Continuous positive airway pressure
6Continuous Positive Airway Pressure - methods
7Developing Countries
8Female
9Health aspects
10Humans
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13Hypoxia - therapy
14Infant
15Internal Medicine
16Length of Stay - statistics & numerical data
17Male
18Mortality
19Oxygen
20Oxygen Inhalation Therapy - methods
21Pneumonia
22Pneumonia - complications
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24Respiratory therapy
25Treatment Outcome
26United Kingdom
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titleBubble continuous positive airway pressure for children with severe pneumonia and hypoxaemia in Bangladesh: an open, randomised controlled trial
authorChisti, Mohammod J, PhD ; Salam, Mohammed A, MBBS ; Smith, Jonathan H, FRCA ; Ahmed, Tahmeed, Prof ; Pietroni, Mark A C, Prof ; Shahunja, K M, MBBS ; Shahid, Abu S M S B, MBBS ; Faruque, Abu S G, MPH ; Ashraf, Hasan, MD ; Bardhan, Pradip K, MD ; Sharifuzzaman, MBBS ; Graham, Stephen M, Prof ; Duke, Trevor, Prof
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24Respiratory therapy
25Treatment Outcome
26United Kingdom
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eissn1474-547X
codenLANCAO
abstractSummary Background In developing countries, mortality in children with very severe pneumonia is high, even with the provision of appropriate antibiotics, standard oxygen therapy, and other supportive care. We assessed whether oxygen therapy delivered by bubble continuous positive airway pressure (CPAP) improved outcomes compared with standard low-flow and high-flow oxygen therapies. Methods This open, randomised, controlled trial took place in Dhaka Hospital of the International Centre for Diarrhoeal Disease Research, Bangladesh. We randomly assigned children younger than 5 years with severe pneumonia and hypoxaemia to receive oxygen therapy by either bubble CPAP (5 L/min starting at a CPAP level of 5 cm H2 O), standard low-flow nasal cannula (2 L/min), or high-flow nasal cannula (2 L/kg per min up to the maximum of 12 L/min). Randomisation was done with use of the permuted block methods (block size of 15 patients) and Fisher and Yates tables of random permutations. The primary outcome was treatment failure (ie, clinical failure, intubation and mechanical ventilation, death, or termination of hospital stay against medical advice) after more than 1 h of treatment. Primary and safety analyses were by intention to treat. We did two interim analyses and stopped the trial after the second interim analysis on Aug 3, 2013, as directed by the data safety and monitoring board. This trial is registered at ClinicalTrials.gov , number NCT01396759. Findings Between Aug 4, 2011, and July 17, 2013, 225 eligible children were recruited. We randomly allocated 79 (35%) children to receive oxygen therapy by bubble CPAP, 67 (30%) to low-flow oxygen therapy, and 79 (35%) to high-flow oxygen therapy. Treatment failed for 31 (14%) children, of whom five (6%) had received bubble CPAP, 16 (24%) had received low-flow oxygen therapy, and ten (13%) had received high-flow oxygen therapy. Significantly fewer children in the bubble CPAP group had treatment failure than in the low-flow oxygen therapy group (relative risk [RR] 0·27, 99·7% CI 0·07–0·99; p=0·0026). No difference in treatment failure was noted between patients in the bubble CPAP and those in the high-flow oxygen therapy group (RR 0·50, 99·7% 0·11–2·29; p=0·175). 23 (10%) children died. Three (4%) children died in the bubble CPAP group, ten (15%) children died in the low-flow oxygen therapy group, and ten (13%) children died in the high-flow oxygen therapy group. Children who received oxygen by bubble CPAP had significantly lower rates of death than the children who received oxygen by low-flow oxygen therapy (RR 0·25, 95% CI 0·07–0·89; p=0·022). Interpretation Oxygen therapy delivered by bubble CPAP improved outcomes in Bangladeshi children with very severe pneumonia and hypoxaemia compared with standard low-flow oxygen therapy. Use of bubble CPAP oxygen therapy could have a large effect in hospitals in developing countries where the only respiratory support for severe childhood pneumonia and hypoxaemia is low-flow oxygen therapy. The trial was stopped early because of higher mortality in the low-flow oxygen group than in the bubble CPAP group, and we acknowledge that the early cessation of the trial reduces the certainty of the findings. Further research is needed to test the feasibility of scaling up bubble CPAP in district hospitals and to improve bubble CPAP delivery technology. Funding International Centre for Diarrhoeal Disease Research, Bangladesh, and Centre for International Child Health, University of Melbourne.
copEngland
pubElsevier Ltd
pmid26296950
doi10.1016/S0140-6736(15)60249-5