Efficacy and economic assessment of conventional ventilatory support versus extracorporeal membrane oxygenation for severe adult respiratory failure (CESAR): a multicentre randomised controlled trial
Efficacy and economic assessment of conventional ventilatory support versus extracorporeal membrane oxygenation for severe adult respiratory failure (CESAR): a multicentre randomised controlled trial
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DOI：
10.1016/s0140-6736(09)61069-2
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发表时间：
2009-10-17
期刊：
影响因子：
168.9
通讯作者：
Elbourne, Diana
中科院分区：
文献类型：
--
作者：
Peek, Giles J.;Mugford, Miranda;Elbourne, Diana
背景：尽管通气技术和其他治疗方法（如类固醇、俯卧位、支气管镜检查和吸入一氧化氮）有所改进，成人严重急性呼吸衰竭仍导致高死亡率。我们的目的是描述体外膜氧合（ECMO）与传统通气支持相比的安全性、临床疗效和成本效益。方法：在这项英国的多中心试验中，我们使用独立的中央随机化服务，以1:1的比例随机分配180名成年人接受持续的传统管理或转诊考虑接受ECMO治疗。符合条件的患者年龄为18-65岁，重度（Murray评分>3.0或pH 30 cm H2O峰值吸气压）或高FiO(2)（>0.8）通气超过7天；颅内出血;有限肝素化的其他禁忌症；或继续积极治疗的禁忌症。主要结局为随机分组后6个月或出院前死亡或严重残疾。初步分析以意向治疗为主。只有那些进行了6个月随访的研究人员才被隐瞒了治疗任务。收集了有关资源利用和经济结果（质量调整生命年）的数据。对产生关键成本的事件进行了研究，我们在随机化后6个月对成本效用进行了分析，并模拟了终身成本效用。本研究已注册，注册号为ISRCTN47279827。结果：共筛查766例患者；入组180例，随机分配考虑采用ECMO治疗（n=90例）或接受常规治疗（n=90例）。68例（75%）患者实际接受了ECMO；考虑采用ECMO治疗的患者中有63%（57/90）存活至6个月无残疾，而采用常规治疗的患者中有47%（41/87）存活（相对风险0.69;95% CI 0.05-0.97, p=0.03）。在6个月的随访中，考虑采用ECMO治疗导致质量调整生命年（QALYs）增加0.03。终身模型预测ECMO的每QALY成本为19252英镑（95% CI 7622-59 200），折扣率为3.5%。我们建议将Murray评分超过3.0或在最佳常规管理下pH值小于7.20的严重但可能可逆的呼吸衰竭成年患者转移到一个基于ecmo管理方案的中心，以显着提高生存率，无严重残疾。在与英国服务类似的环境中，这种策略也可能具有成本效益。
Background Severe acute respiratory failure in adults causes high mortality despite improvements in ventilation techniques and other treatments (eg, steroids, prone positioning, bronchoscopy, and inhaled nitric oxide). We aimed to delineate the safety clinical efficacy, and cost-effectiveness of extracorporeal membrane oxygenation (ECMO) compared with conventional ventilation support.Methods in this UK-based multicentre trial, we used an independent central randomisation service to randomly assign 180 adults in a 1:1 ratio to receive continued conventional management or referral to consideration for treatment by ECMO. Eligible patients were aged 18-65 years and had severe (Murray score >3.0 or pH 30 cm H2O of peak inspiratory pressure) or high FiO(2) (>0.8) ventilation for more than 7 days; intracranial bleeding; any other contraindication to limited heparinisation; or any contraindication to continuation of active treatment. The primary outcome was death or severe disability at 6 months after randomisation or before discharge from hospital. Primary analysis was by intention to treat. Only researchers who did the 6-month follow-up were masked to treatment assignment. Data about resource use and economic outcomes (quality-adjusted life-years) were collected. Studies of the key cost generating events were undertaken, and we did analyses of cost-utility at 6 months after randomisation and modelled lifetime cost-utility. This study is registered, number ISRCTN47279827.Findings 766 patients were screened; 180 were enrolled and randomly allocated to consideration for treatment by ECMO (n=90 patients) or to receive conventional management (n=90). 68 (75%) patients actually received ECMO; 63% (57/90) of patients allocated to consideration for treatment by ECMO survived to 6 months without disability compared with 47% (41/87) of those allocated to conventional management (relative risk 0.69; 95% CI 0.05-0.97, p=0.03). Referral to consideration for treatment by ECMO treatment led to a gain of 0.03 quality-adjusted life-years (QALYs) at 6-month follow-up. A lifetime model predicted the cost per QALY of ECMO to be 19252 pound (95% CI 7622-59 200) at a discount rate of 3.5%.Interpretation We recommend transferring of adult patients with severe but potentially reversible respiratory failure, whose Murray score exceeds 3.0 or who have a pH of less than 7.20 on optimum conventional management, to a centre with an ECMO-based management protocol to significantly improve survival without severe disability. This strategy is also likely to be cost effective in settings with similar services to those in the UK.