Nasal high-flow compared to non-invasive ventilation in treatment of acute acidotic hypercapnic exacerbation of chronic obstructive pulmonary disease-protocol for a randomized controlled noninferiority trial (ELVIS)

Jens Bräunlich, Nicole Köppe-Bauernfeind, David Petroff, Annegret Franke, Hubert Wirtz, Jens Bräunlich, Nicole Köppe-Bauernfeind, David Petroff, Annegret Franke, Hubert Wirtz

Abstract

Background: Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) have a major negative impact on health status, rates of hospitalization, readmission, disease progression and mortality. Non-invasive ventilation (NIV) is the standard therapy for hypercapnic acidotic respiratory failure in AECOPD. Despite its beneficial effects, NIV is often poorly tolerated (11-34 % failure rate). An increasing number of studies have documented a beneficial effect of nasal high-flow (NHF) in acute hypercapnia. We designed a prospective, randomized, multi-centre, open label, non-inferiority trial to compare treatment failure in nasal NHF vs NIV in patients with acidotic hypercapnic AECOPD.

Methods: The study will be conducted in about 35 sites in Germany. Patients with hypercapnic AECOPD with respiratory acidosis (pH < 7.35) will be randomized 1:1 to NIV or NHF. The primary outcome is the combined endpoint of intubation, treatment failure or death at 72 h. The switch from one to the other device marks a device failure but acts as a rescue treatment in absence of intubation criteria. A sample size of 720 was calculated to have 80% power for showing that NHF is non-inferior to NIV with a margin of 8 percentage points. Linear regression will be used for the confirmatory analysis.

Discussion: If NHF is shown to be non-inferior to NIV in acidotic hypercapnic AECOPD, it could become an important alternative treatment.

Trial registration: ClinicalTrials.gov , NCT04881409 , Registered on May 11, 2021.

Keywords: Acidotic hypercapnic exacerbation; COPD; Chronic obstructive pulmonary disease; Nasal high-flow; Non-invasive ventilation; Randomized controlled trial, RCT; intubation.

Conflict of interest statement

JB received speaker fees from Fisher&Paykel Healthcare, grants, equipment and speaker fees from TNI medical AG, speaker fees from Masimo.

HW received grants, equipment and speaker fees from TNI medical AG.

No other authors report conflicts of interest.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Study flow chart according to the Consolidated Standards of Reporting Trials

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