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Published in: Trials 1/2019

Open Access 01-12-2019 | Respiratory Acidosis | Study protocol

High-flow nasal therapy versus noninvasive ventilation in COPD patients with mild-to-moderate hypercapnic acute respiratory failure: study protocol for a noninferiority randomized clinical trial

Authors: Andrea Cortegiani, Federico Longhini, Annalisa Carlucci, Raffaele Scala, Paolo Groff, Andrea Bruni, Eugenio Garofalo, Maria Rita Taliani, Uberto Maccari, Luigi Vetrugno, Enrico Lupia, Giovanni Misseri, Vittoria Comellini, Antonino Giarratano, Stefano Nava, Paolo Navalesi, Cesare Gregoretti

Published in: Trials | Issue 1/2019

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Abstract

Background

Noninvasive ventilation (NIV) is indicated to treat respiratory acidosis due to exacerbation of chronic obstructive pulmonary disease (COPD). Recent nonrandomized studies also demonstrated some physiological effects of high-flow nasal therapy (HFNT) in COPD patients. We designed a prospective, unblinded, multicenter, randomized controlled trial to assess the noninferiority of HFNT compared to NIV with respect to the reduction of arterial partial pressure of carbon dioxide (PaCO2) in patients with hypercapnic acute respiratory failure with mild-to-moderate respiratory acidosis.

Methods

We will enroll adult patients with acute hypercapnic respiratory failure, as defined by arterial pH between 7.25 and 7.35 and PaCO2 ≥ 55 mmHg. Patients will be randomly assigned 1:1 to receive NIV or HFNT. NIV will be applied through a mask with a dedicated ventilator in pressure support mode. Positive end-expiratory pressure will be set at 3–5 cmH2O with inspiratory support to obtain a tidal volume between 6 and 8 ml/kg of ideal body weight. HFNT will be initially set at a temperature of 37 °C and a flow of 60 L/min. At 2 and 6 h we will assess arterial blood gases, vital parameters, respiratory rate, treatment intolerance and failure, need for endotracheal intubation, time spent under mechanical ventilation (both invasive and NIV), intensive care unit and hospital length of stay, and hospital mortality.
Based on an α error of 5% and a β error of 80%, with a standard deviation for PaCO2 equal to 15 mmHg and a noninferiority limit of 10 mmHg, we computed a sample size of 56 patients. Considering potential drop-outs and nonparametric analysis, the final computed sample size was 80 patients (40 per group).

Discussion

HFNT is more comfortable than NIV in COPD patients recovering from an episode of exacerbation. If HFNT would not be inferior to NIV, HFNT could be considered as an alternative to NIV to treat COPD patients with mild-to-moderate respiratory acidosis.

Trial registration

ClinicalTrials.gov, NCT03370666. Registered on December 12, 2017.
Appendix
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Metadata
Title
High-flow nasal therapy versus noninvasive ventilation in COPD patients with mild-to-moderate hypercapnic acute respiratory failure: study protocol for a noninferiority randomized clinical trial
Authors
Andrea Cortegiani
Federico Longhini
Annalisa Carlucci
Raffaele Scala
Paolo Groff
Andrea Bruni
Eugenio Garofalo
Maria Rita Taliani
Uberto Maccari
Luigi Vetrugno
Enrico Lupia
Giovanni Misseri
Vittoria Comellini
Antonino Giarratano
Stefano Nava
Paolo Navalesi
Cesare Gregoretti
Publication date
01-12-2019
Publisher
BioMed Central
Published in
Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-019-3514-1

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