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.T

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.

Links

PMC Free PDF

Authors+Show Affiliations

Liu S

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.

Walline JH

Centre for the Humanities and Medicine, The University of Hong Kong, Hong Kong, China.

MeSH

HumansNoninvasive VentilationCannulaOxygen Inhalation TherapyPulmonary Disease, Chronic ObstructiveLungRespiratory InsufficiencyRandomized Controlled Trials as Topic

Pub Type(s)

Clinical Trial Protocol

Journal Article

Language

eng

PubMed ID

36581995

Citation

Liu, Shuai, et al. "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, vol. 23, no. 1, 2022, p. 1060.

Liu S, Walline JH, Zhu H, et al. 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;23(1):1060.

Liu, S., Walline, J. H., Zhu, H., Li, Y., Wang, C., & Liu, J. (2022). 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, 23(1), 1060. https://doi.org/10.1186/s13063-022-06963-w

Liu S, et al. 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. PubMed PMID: 36581995.

* Article titles in AMA citation format should be in sentence-case

TY - JOUR T1 - 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. AU - Liu,Shuai, AU - Walline,Joseph Harold, AU - Zhu,Huadong, AU - Li,Yan, AU - Wang,Chunting, AU - Liu,Jihai, Y1 - 2022/12/29/ PY - 2022/2/24/received PY - 2022/11/27/accepted PY - 2022/12/29/entrez PY - 2022/12/30/pubmed PY - 2023/1/3/medline KW - Chronic obstructive pulmonary disease KW - High-flow nasal cannula KW - Hospital emergency service KW - Intensive care units KW - Noninvasive ventilation KW - Respiratory insufficiency SP - 1060 EP - 1060 JF - Trials JO - Trials VL - 23 IS - 1 N2 - 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. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/36581995/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_ DB - PRIME DP - Unbound Medicine ER -

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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.T