TY - JOUR T1 - Nasal high-flow oxygen <em>versus</em> noninvasive ventilation in acute exacerbation of COPD: protocol for a randomised noninferiority clinical trial JF - ERJ Open Research JO - erjor DO - 10.1183/23120541.00114-2020 VL - 6 IS - 4 SP - 00114-2020 AU - Athanasia Papalampidou AU - Eleni Bibaki AU - Stylianos Boutlas AU - Ioannis Pantazopoulos AU - Nikolaos Athanasiou AU - Melanie Moylan AU - Vasileios Vlachakos AU - Vasileios Grigoropoulos AU - Konstantinos Eleftheriou AU - Zoe Daniil AU - Konstantinos Gourgoulianis AU - Ioannis Kalomenidis AU - Spyros Zakynthinos AU - Eleni Ischaki Y1 - 2020/10/01 UR - http://openres.ersjournals.com/content/6/4/00114-2020.abstract N2 - Background 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.Aim 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.Methods We designed a multicentre, prospective, randomised trial on patients with AECOPD, who have pH&lt;7.35 but &gt;7.25 and PaCO2 &gt;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 SpO2 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.Conclusion 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.Nasal high-flow oxygen could be an effective alternative to NIV respiratory support for patients with mild-to-moderate #AECOPD, especially for those who do not tolerate or have contraindications for NIV https://bit.ly/3bgxDYx ER -