Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2020 Oct 19;6(4):00114-2020.
doi: 10.1183/23120541.00114-2020. eCollection 2020 Oct.

Nasal high-flow oxygen versus noninvasive ventilation in acute exacerbation of COPD: protocol for a randomised noninferiority clinical trial

Athanasia Papalampidou  1   2 , Eleni Bibaki  3   2 , Stylianos Boutlas  4 , Ioannis Pantazopoulos  5 , Nikolaos Athanasiou  6 , Melanie Moylan  7 , Vasileios Vlachakos  1 , Vasileios Grigoropoulos  1 , Konstantinos Eleftheriou  1 , Zoe Daniil  4 , Konstantinos Gourgoulianis  4 , Ioannis Kalomenidis  1 , Spyros Zakynthinos  1 , Eleni Ischaki  1
Affiliations

Nasal high-flow oxygen versus noninvasive ventilation in acute exacerbation of COPD: protocol for a randomised noninferiority clinical trial

Athanasia Papalampidou et al. ERJ Open Res. .

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 P aCO2 >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 S pO2 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.

PubMed Disclaimer

Conflict of interest statement

Conflict of interest: A. Papalampidou reports nonfinancial support from Fisher & Paykel in the form of devices and consumables during the conduct of the study. Conflict of interest: E. Bibaki reports nonfinancial support from Fisher & Paykel in the form of devices and consumables during the conduct of the study. Conflict of interest: S. Boutlas reports nonfinancial support from Fisher & Paykel in the form of devices and consumables during the conduct of the study. Conflict of interest: I. Pantazopoulos reports nonfinancial support from Fisher & Paykel in the form of devices and consumables during the conduct of the study. Conflict of interest: N. Athanasiou reports nonfinancial support from Fisher & Paykel in the form of devices and consumables during the conduct of the study. Conflict of interest: M. Moylan has nothing to disclose. Conflict of interest: V. Vlachakos reports nonfinancial support from Fisher & Paykel in the form of devices and consumables during the conduct of the study. Conflict of interest: V. Grigoropoulos reports nonfinancial support from Fisher & Paykel in the form of devices and consumables during the conduct of the study. Conflict of interest: K. Eleftheriou reports nonfinancial support from Fisher & Paykel in the form of devices and consumables during the conduct of the study. Conflict of interest: Z. Daniil reports nonfinancial support from Fisher & Paykel in the form of devices and consumables during the conduct of the study. Conflict of interest: K. Gourgoulianis reports nonfinancial support from Fisher & Paykel in the form of devices and consumables during the conduct of the study. Conflict of interest: L. Kalomenidis reports nonfinancial support from Fisher & Paykel in the form of devices and consumables during the conduct of the study. Conflict of interest: S. Zakynthinos reports nonfinancial support from Fisher & Paykel in the form of devices and consumables during the conduct of the study. Conflict of interest: E. Ischaki reports nonfinancial support from Fisher & Paykel in the form of devices and consumables during the conduct of the study.

Figures

FIGURE 1
FIGURE 1
Flow diagram of study protocol. PaCO2: arterial CO2 tension; RR: respiratory rate; VAS: visual analogue scale.
See this image and copyright information in PMC

References

    1. Singh D, Agusti A, Anzueto A, et al. . Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Lung Disease: the GOLD science committee report 2019. Eur Respir J 2019; 53: 1900164. doi:10.1183/13993003.00164-2019 - DOI - PubMed
    1. O'Donnell DE, Parker CM. COPD exacerbations. 3: pathophysiology. Thorax 2006; 61: 354–361. doi:10.1136/thx.2005.041830 - DOI - PMC - PubMed
    1. Ambrosino N, Vagheggini G. Non-invasive ventilation in exacerbations of COPD. Int J Chron Obstruct Pulmon Dis 2007; 2: 471–476. - PMC - PubMed
    1. Nava S, Navalesi P, Conti G. Time of non-invasive ventilation. Intensive Care Med 2006; 32: 361–370. doi:10.1007/s00134-005-0050-0 - DOI - PubMed
    1. Contou D, Fragnoli C, Córdoba-Izquierdo A, et al. . Noninvasive ventilation for acute hypercapnic respiratory failure: intubation rate in an experienced unit. Respir Care 2013; 58: 2045–2052. doi:10.4187/respcare.02456 - DOI - PubMed

LinkOut - more resources