High-flow nasal cannula therapy with sequential noninvasive ventilation versus noninvasive ventilation alone as the initial ventilatory strategy in acute COPD exacerbations: study protocol for a randomized controlled trial

Shuai Liu; Joseph Harold Walline; Huadong Zhu; Yan Li; Chunting Wang; Jihai Liu

doi:10.1186/s13063-022-06963-w

High-flow nasal cannula therapy with sequential noninvasive ventilation versus noninvasive ventilation alone as the initial ventilatory strategy in acute COPD exacerbations: study protocol for a randomized controlled trial

Trials. 2022 Dec 29;23(1):1060. doi: 10.1186/s13063-022-06963-w.

Authors

Shuai Liu¹, Joseph Harold Walline², Huadong Zhu³, Yan Li¹, Chunting Wang¹, Jihai Liu¹

Affiliations

¹ Emergency Department, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing, 100730, China.
² Centre for the Humanities and Medicine, The University of Hong Kong, Hong Kong, China.
³ Emergency Department, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing, 100730, China. zhuhuadong1970@126.com.

Abstract

Background: Noninvasive ventilation (NIV) is the recommended mode of ventilation used in acute respiratory failure secondary to an acute exacerbation of chronic obstructive pulmonary disease (AECOPD). Recent data has shown that high-flow nasal cannula (HFNC) treatment can be an alternative for patients with hypercapnic respiratory failure. The purpose of this study is to evaluate HFNC with sequential NIV versus NIV alone as the initial ventilatory strategy in AECOPD.

Methods: This investigator-initiated, unblinded, single center, randomized controlled trial will be conducted in the emergency department, emergency intensive care unit, or respiratory intensive care unit of a tertiary-care urban teaching hospital. A total of 66 patients will be enrolled and randomized into the intervention group (HFNC with sequential NIV) or the control group (NIV group). The primary endpoint will be the mean difference in PaCO₂ from baseline to 24 h after randomization. Secondary endpoints include the mean difference in PaCO₂ from baseline to 6, 12, and 18 h, as well as the dyspnea score, overall discomfort score, rate of treatment failure, respiratory rate, rate of endotracheal intubation, length of hospital stay, and mortality.

Discussion: Taking the advantages of both HFNC and NIV on AECOPD patients into account, we designed this clinical trial to investigate the combination of these ventilatory strategies. This trial will help us understand how HFNC with sequential NIV compares to NIV alone in treating AECOPD patients.

Trial registration: ChiCTR2100054809.

Keywords: Chronic obstructive pulmonary disease; High-flow nasal cannula; Hospital emergency service; Intensive care units; Noninvasive ventilation; Respiratory insufficiency.

Publication types

Clinical Trial Protocol

MeSH terms

Cannula
Humans
Lung
Noninvasive Ventilation* / adverse effects
Noninvasive Ventilation* / methods
Oxygen Inhalation Therapy / adverse effects
Oxygen Inhalation Therapy / methods
Pulmonary Disease, Chronic Obstructive* / complications
Pulmonary Disease, Chronic Obstructive* / diagnosis
Pulmonary Disease, Chronic Obstructive* / therapy
Randomized Controlled Trials as Topic
Respiratory Insufficiency* / diagnosis
Respiratory Insufficiency* / etiology
Respiratory Insufficiency* / therapy