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Nasal high-flow oxygen versus noninvasive ventilation in acute exacerbation of copd: Protocol for a randomised noninferiority clinical trial
dc.creator | Papalampidou A., Bibaki E., Boutlas S., Pantazopoulos I., Athanasiou N., Moylan M., Vlachakos V., Grigoropoulos V., Eleftheriou K., Daniil Z., Gourgoulianis K., Kalomenidis I., Zakynthinos S., Ischaki E. | en |
dc.date.accessioned | 2023-01-31T09:43:43Z | |
dc.date.available | 2023-01-31T09:43:43Z | |
dc.date.issued | 2020 | |
dc.identifier | 10.1183/23120541.00114-2020 | |
dc.identifier.issn | 23120541 | |
dc.identifier.uri | http://hdl.handle.net/11615/77749 | |
dc.description.abstract | 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<7.35 but >7.25 and PaCO2 >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. © ERS 2020. | en |
dc.language.iso | en | en |
dc.source | ERJ Open Research | en |
dc.source.uri | https://www.scopus.com/inward/record.uri?eid=2-s2.0-85114064651&doi=10.1183%2f23120541.00114-2020&partnerID=40&md5=decd25def07e817e03504a1671d2479a | |
dc.subject | acidemia | en |
dc.subject | arterial oxygen saturation | en |
dc.subject | Article | en |
dc.subject | blood carbon dioxide tension | en |
dc.subject | breathing mechanics | en |
dc.subject | breathing muscle | en |
dc.subject | breathing rate | en |
dc.subject | chronic obstructive lung disease | en |
dc.subject | comparative study | en |
dc.subject | controlled study | en |
dc.subject | flow rate | en |
dc.subject | forced expiratory volume | en |
dc.subject | forced vital capacity | en |
dc.subject | Glasgow coma scale | en |
dc.subject | heart arrest | en |
dc.subject | heart arrhythmia | en |
dc.subject | heart supraventricular arrhythmia | en |
dc.subject | hemodynamics | en |
dc.subject | high flow nasal cannula therapy | en |
dc.subject | hospitalization | en |
dc.subject | human | en |
dc.subject | hypoxemia | en |
dc.subject | major clinical study | en |
dc.subject | multicenter study | en |
dc.subject | noninvasive ventilation | en |
dc.subject | outcome assessment | en |
dc.subject | pneumothorax | en |
dc.subject | positive pressure ventilation | en |
dc.subject | prospective study | en |
dc.subject | pulse oximetry | en |
dc.subject | randomized controlled trial | en |
dc.subject | respiratory failure | en |
dc.subject | thoracoabdominal asynchrony | en |
dc.subject | treatment failure | en |
dc.subject | visual analog scale | en |
dc.subject | European Respiratory Society | en |
dc.title | Nasal high-flow oxygen versus noninvasive ventilation in acute exacerbation of copd: Protocol for a randomised noninferiority clinical trial | en |
dc.type | journalArticle | en |
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