Bubble continuous positive airway pressure for children with severe pneumonia and hypoxaemia in Bangladesh: an open, randomised controlled trial
Bubble continuous positive airway pressure for children with severe pneumonia and hypoxaemia in Bangladesh: an open, randomised controlled trial
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DOI：
10.1016/s0140-6736(15)60249-5
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发表时间：
2015-09-12
期刊：
影响因子：
168.9
通讯作者：
Duke, Trevor
中科院分区：
文献类型：
--
作者：
Chisti, Mohammod J.;Salam, Mohammed A.;Duke, Trevor
在发展中国家，即使提供了适当的抗生素、标准氧气治疗和其他支持性护理，极重度肺炎儿童的死亡率仍很高。我们评估了是否氧气治疗提供的气泡持续气道正压通气（CPAP）改善的结果相比，标准的低流量和高流量oxygentherapy.Methods这个开放的，随机的，对照试验发生在达卡医院的国际中心腹泻病研究，孟加拉国。我们将5岁以下的重症肺炎和低氧血症儿童随机分配接受气泡CPAP（从5 cm H2O的CPAP水平开始，5 L/min）、标准低流量鼻插管（2 L/min）或高流量鼻插管（2 L/kg/min，最高12 L/min）的氧疗。使用排列区组方法（区组大小为15例患者）和Fisher和Yates随机排列表进行随机化。主要结局为治疗超过1小时后的治疗失败（即临床失败、插管和机械通气、死亡或违背医嘱终止住院）。我们进行了两次中期分析，并在2013年8月3日第二次中期分析后停止了试验，这是数据安全和监测委员会的指示。该试验在ClinicalTrials.gov上注册，编号NCT 01396759。结果在2011年8月4日至2013年7月17日期间，招募了225名符合条件的儿童。我们将79名（35%）儿童随机分配接受气泡CPAP氧气治疗，67名（30%）接受低流量氧气治疗，79名（35%）接受高流量氧气治疗。31名（14%）儿童治疗失败，其中5名（6%）接受了气泡CPAP治疗，16名（24%）接受了低流量氧疗，10名（13%）接受了高流量氧疗。气泡CPAP组治疗失败的儿童明显少于低流量氧疗组（相对风险[RR] 0.27，99.7% CI 0.07-0.99; p=0.0026）。气泡CPAP组和高流量氧疗组的患者在治疗失败方面没有差异（RR 0.50，99.7% 0.11-2.29; p=0.175）。23名（10%）儿童死亡。气泡CPAP组有3名（4%）儿童死亡，低流量氧疗组有10名（15%）儿童死亡，高流量氧疗组有10名（13%）儿童死亡。接受气泡CPAP吸氧的儿童死亡率显著低于接受低流量吸氧的儿童（RR 0.25，95%CI 0.07-0.89; p=0.022）。解释与标准低流量吸氧相比，接受气泡CPAP吸氧的孟加拉国儿童重症肺炎和低氧血症的预后得到改善。在发展中国家的医院中，使用气泡式CPAP氧气治疗可能会产生很大的效果，因为对严重儿童肺炎和低氧血症的唯一呼吸支持是低流量氧气治疗。由于低流量氧气组的死亡率高于气泡CPAP组，因此试验提前停止，我们承认试验的提前停止降低了结果的确定性。需要进一步的研究来测试在地区医院扩大气泡CPAP的可行性，并改进气泡CPAP输送技术。
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 H2O), 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.