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.
Abstract
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
Footnotes
This study is registered at www.clinicaltrials.gov with identifier number NCT03466385. Data that are planned to be shared are the study protocol, statistical analysis and clinical study report. They will be shared 3 months after study publication with anyone who is interested in writing a meta-analysis or review.
Trial status: The study is currently recruiting. The first patient was enrolled in November 2018. Recruitment is expected to be completed by 31 December, 2021.
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.
Support statement: All authors would like to acknowledge the support of the Special Account for Research Grants of the National and Kapodistrian University of Athens, Greece.
- Received March 4, 2020.
- Accepted August 10, 2020.
- Copyright ©ERS 2020
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