High-flow nasal therapy versus noninvasive ventilation in COPD patients with mild-to-moderate hypercapnic acute respiratory failure: study protocol for a noninferiority randomized clinical trial
High-flow nasal therapy versus noninvasive ventilation in COPD patients with mild-to-moderate hypercapnic acute respiratory failure: study protocol for a noninferiority randomized clinical trial
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DOI：
10.1186/s13063-019-3514-1
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发表时间：
2019-07-22
期刊：
影响因子：
2.5
通讯作者：
Gregoretti, Cesare
中科院分区：
文献类型：
--
作者：
Cortegiani, Andrea;Longhini, Federico;Gregoretti, Cesare
背景无创通气（NIV）用于治疗慢性阻塞性肺疾病（COPD）加重引起的呼吸性酸中毒。最近的非随机研究也证明了高流量鼻治疗（HFNT）在COPD患者中的一些生理作用。我们设计了一项前瞻性、非盲、多中心、随机对照试验，以评估HFNT与NIV相比在降低伴有轻度至中度呼吸性酸中毒的高碳酸血症急性呼吸衰竭患者的动脉二氧化碳分压（PaCO 2）方面的非劣效性。定义为动脉pH值在7.25和7.35之间，PaCO 2>= 55 mmHg。患者将以1：1的比例随机分配接受NIV或HFNT。NIV将在压力支持模式下通过配有专用呼吸机的面罩应用。呼气末正压将设置为3-5 cmH（2）O，吸气支持，以获得6 - 8 ml/kg理想体重的潮气量。HFNT最初将温度设置为37 ℃，流量为60 L/min。在2小时和6小时，我们将评估动脉血气、生命参数、呼吸频率、治疗不耐受和失败、气管插管的需要、机械通气时间（侵入性和NIV）、重症监护室和住院时间以及住院死亡率。基于5%的α误差和80%的β误差，PaCO 2的标准差为15 mmHg，非劣效性限值为10 mmHg，我们计算了56例患者的样本量。考虑到潜在的脱落和非参数分析，最终计算的样本量为80例患者（每组40例）。如果HFNT不劣于NIV，则HFNT可被视为NIV的替代方案，用于治疗轻度至中度呼吸性酸中毒的COPD患者。试验registrationClinicalTrials.gov，NCT 03370666。于2017年12月12日注册。
BackgroundNoninvasive ventilation (NIV) is indicated to treat respiratory acidosis due to exacerbation of chronic obstructive pulmonary disease (COPD). Recent nonrandomized studies also demonstrated some physiological effects of high-flow nasal therapy (HFNT) in COPD patients. We designed a prospective, unblinded, multicenter, randomized controlled trial to assess the noninferiority of HFNT compared to NIV with respect to the reduction of arterial partial pressure of carbon dioxide (PaCO2) in patients with hypercapnic acute respiratory failure with mild-to-moderate respiratory acidosis.MethodsWe will enroll adult patients with acute hypercapnic respiratory failure, as defined by arterial pH between 7.25 and 7.35 and PaCO2 >= 55mmHg. Patients will be randomly assigned 1:1 to receive NIV or HFNT. NIV will be applied through a mask with a dedicated ventilator in pressure support mode. Positive end-expiratory pressure will be set at 3-5 cmH(2)O with inspiratory support to obtain a tidal volume between 6 and 8ml/kg of ideal body weight. HFNT will be initially set at a temperature of 37 degrees C and a flow of 60L/min. At 2 and 6h we will assess arterial blood gases, vital parameters, respiratory rate, treatment intolerance and failure, need for endotracheal intubation, time spent under mechanical ventilation (both invasive and NIV), intensive care unit and hospital length of stay, and hospital mortality.Based on an alpha error of 5% and a beta error of 80%, with a standard deviation for PaCO2 equal to 15mmHg and a noninferiority limit of 10mmHg, we computed a sample size of 56 patients. Considering potential drop-outs and nonparametric analysis, the final computed sample size was 80 patients (40 per group).DiscussionHFNT is more comfortable than NIV in COPD patients recovering from an episode of exacerbation. If HFNT would not be inferior to NIV, HFNT could be considered as an alternative to NIV to treat COPD patients with mild-to-moderate respiratory acidosis.Trial registrationClinicalTrials.gov, NCT03370666. Registered on December 12, 2017.