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.
Acute Disease
Equivalence Trials as Topic
Humans
Hypercapnia
/ diagnosis
Italy
Lung
/ physiopathology
Multicenter Studies as Topic
Noninvasive Ventilation
/ adverse effects
Oxygen Inhalation Therapy
/ adverse effects
Prospective Studies
Pulmonary Disease, Chronic Obstructive
/ diagnosis
Respiratory Insufficiency
/ diagnosis
Time Factors
Treatment Outcome
Acute respiratory failure
Carbon dioxide
Chronic obstructive pulmonary disease
Emergency department
High-flow oxygen therapy through nasal cannula
Intensive care unit
Noninvasive ventilation
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
22 Jul 2019
22 Jul 2019
Historique:
received:
29
03
2019
accepted:
10
06
2019
entrez:
24
7
2019
pubmed:
25
7
2019
medline:
6
2
2020
Statut:
epublish
Résumé
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 (PaCO We will enroll adult patients with acute hypercapnic respiratory failure, as defined by arterial pH between 7.25 and 7.35 and PaCO 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. ClinicalTrials.gov, NCT03370666 . Registered on December 12, 2017.
Sections du résumé
BACKGROUND
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 (PaCO
METHODS
METHODS
We will enroll adult patients with acute hypercapnic respiratory failure, as defined by arterial pH between 7.25 and 7.35 and PaCO
DISCUSSION
CONCLUSIONS
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
BACKGROUND
ClinicalTrials.gov, NCT03370666 . Registered on December 12, 2017.
Identifiants
pubmed: 31331372
doi: 10.1186/s13063-019-3514-1
pii: 10.1186/s13063-019-3514-1
pmc: PMC6647141
doi:
Banques de données
ClinicalTrials.gov
['NCT03370666']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
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