Papalampidou Athanasia, Bibaki Eleni, Boutlas Stylianos, Pantazopoulos Ioannis, Athanasiou Nikolaos, Moylan Melanie, Vlachakos Vasileios, Grigoropoulos Vasileios, Eleftheriou Konstantinos, Daniil Zoe, Gourgoulianis Konstantinos, Kalomenidis Ioannis, Zakynthinos Spyros, Ischaki Eleni
First Dept of Critical Care Medicine and Pulmonary Services, Medical School of Athens, Evangelismos Hospital, Athens, Greece.
Both authors contributed equally to this manuscript.
ERJ Open Res. 2020 Oct 19;6(4). doi: 10.1183/23120541.00114-2020. eCollection 2020 Oct.
Noninvasive ventilation (NIV) is considered as the first-line treatment for acute exacerbation of COPD (AECOPD) complicated by respiratory acidosis. Recent studies demonstrate a role of nasal high-flow oxygen (NHF) in AECOPD as an alternative treatment in patients intolerant to NIV or with contraindications to it.
The study aimed to evaluate whether NHF respiratory support is noninferior compared to NIV in respect to treatment failure, defined as need for intubation or change to alternative treatment group, in patients with AECOPD and mild-to-moderate acute or acute-on-chronic hypercapnic respiratory failure.
We designed a multicentre, prospective, randomised trial on patients with AECOPD, who have pH<7.35 but >7.25 and >45 mmHg, in whom NIV is indicated as a first-line treatment. According to power analysis, 498 participants will be required for establishing noninferiority of NHF compared to NIV. Patients will be randomly assigned to receive NIV or NHF. Treatment will be adjusted to maintain between 88%-92% for both groups. Arterial blood gases, respiratory variables, comfort, dyspnoea score and any pulmonary or extrapulmonary complications will be assessed at baseline, before treatment initiation, and at 1, 2, 4, 6, 12, 24, 48 h, then once daily from day 3 to patient discharge, intubation or death.
Given the increasing number of studies demonstrating the physiological effects of NHF in COPD patients, we hypothesise that NHF respiratory support will be noninferior to NIV in patients with AECOPD and mild-to-moderate acute or acute on chronic hypercapnic respiratory failure.
无创通气（NIV）被视为慢性阻塞性肺疾病急性加重（AECOPD）合并呼吸性酸中毒的一线治疗方法。最近的研究表明，经鼻高流量给氧（NHF）在AECOPD中可作为不耐受NIV或有NIV禁忌证患者的替代治疗方法。
本研究旨在评估在AECOPD合并轻至中度急性或慢性高碳酸血症性呼吸衰竭患者中，就治疗失败（定义为需要插管或转至替代治疗组）而言，NHF呼吸支持是否不劣于NIV。
我们针对pH<7.35但>7.25且PaCO₂>45 mmHg、NIV被列为一线治疗方法的AECOPD患者设计了一项多中心、前瞻性、随机试验。根据功效分析，为确定NHF相对于NIV的非劣效性，需要498名参与者。患者将被随机分配接受NIV或NHF治疗。两组均将调整治疗以维持SpO₂在88%-92%之间。将在基线、治疗开始前以及1、2、4、6、12、24、48小时评估动脉血气、呼吸变量、舒适度、呼吸困难评分以及任何肺部或肺外并发症，然后从第3天至患者出院、插管或死亡期间每天评估一次。
鉴于越来越多的研究证明NHF对COPD患者的生理作用，我们假设在AECOPD合并轻至中度急性或慢性高碳酸血症性呼吸衰竭患者中，NHF呼吸支持不劣于NIV。
