高流量鼻导管通气与无创通气治疗 COPD 合并轻中度高碳酸血症急性呼吸衰竭患者的随机对照非劣效性临床试验方案。
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.
机构信息
Department of Surgical, Oncological and Oral Science (Di.Chir.On.S.), Section of Anesthesia, Analgesia, Intensive Care and Emergency, Policlinico Paolo Giaccone, University of Palermo, Via del vespro 129, 90127, Palermo, Italy.
Intensive Care Unit, Department of Medical and Surgical Sciences, University Hospital Mater Domini, Magna Graecia University, Catanzaro, Italy.
出版信息
Trials. 2019 Jul 22;20(1):450. doi: 10.1186/s13063-019-3514-1.
BACKGROUND
Noninvasive 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 (PaCO) in patients with hypercapnic acute respiratory failure with mild-to-moderate respiratory acidosis.
METHODS
We will enroll adult patients with acute hypercapnic respiratory failure, as defined by arterial pH between 7.25 and 7.35 and PaCO ≥ 55 mmHg. 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 cmHO with inspiratory support to obtain a tidal volume between 6 and 8 ml/kg of ideal body weight. HFNT will be initially set at a temperature of 37 °C and a flow of 60 L/min. At 2 and 6 h 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 α error of 5% and a β error of 80%, with a standard deviation for PaCO equal to 15 mmHg and a noninferiority limit of 10 mmHg, 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).
DISCUSSION
HFNT 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 REGISTRATION
ClinicalTrials.gov, NCT03370666 . Registered on December 12, 2017.
背景
无创通气（NIV）用于治疗慢性阻塞性肺疾病（COPD）加重导致的呼吸性酸中毒。最近的非随机研究还表明，高流量鼻导管治疗（HFNT）对 COPD 患者具有一些生理学影响。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血二氧化碳分压（PaCO）方面的非劣效性。
方法
我们将招募急性高碳酸血症呼吸衰竭的成年患者，定义为动脉 pH 值在 7.25 至 7.35 之间，且 PaCO≥55mmHg。患者将被随机分配 1:1 接受 NIV 或 HFNT。NIV 将通过专用呼吸机在压力支持模式下通过面罩应用。呼气末正压将设置为 3-5cmH2O，吸气支持以获得 6 至 8ml/kg 理想体重的潮气量。HFNT 将初始设置为 37°C 的温度和 60L/min 的流量。在 2 和 6 小时时，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（包括有创和 NIV）的时间、重症监护病房和住院时间、以及住院死亡率。基于 5%的 α 误差和 80%的 β 误差、PaCO 的标准差为 15mmHg 和非劣效性限值为 10mmHg，我们计算出需要 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）。
讨论
HFNT 在 COPD 患者从发作中恢复时比 NIV 更舒适。如果 HFNT 不比 NIV 差，那么 HFNT 可以被认为是治疗伴有轻度至中度呼吸性酸中毒的 COPD 患者的 NIV 的替代方案。
试验注册
ClinicalTrials.gov，NCT03370666。于 2017 年 12 月 12 日注册。
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