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Effectiveness and harms of high-flow nasal oxygen (HFNO) for acute respiratory failure: a systematic review protocol.

ABSTRACT: INTRODUCTION:High-flow nasal oxygen (HFNO) use in adults hospitalised with acute respiratory failure (ARF) is increasing. However, evidence to support widespread use of HFNO compared with non-invasive ventilation (NIV) and conventional oxygen therapy (COT) is unclear. This protocol describes the methods for a systematic evidence review regarding the comparative effectiveness and harms of HFNO compared with NIV or COT for the management of ARF in hospitalised adult patients. METHODS AND ANALYSIS:We will search MEDLINE, Embase, CINAHL and Cochrane Library for randomised-controlled trials (RCTs) of adult patients hospitalised with ARF or who developed ARF while hospitalised. ARF will be defined as SpO2 <90%, PaO2:FiO2 ratio ?300, PaO2 ?60?mm Hg, or PaCO2 ?45?mm Hg. The intervention is HFNO (humidified oxygen, flow rate ?20?L/min) compared separately to NIV or COT. The critical outcomes are: all-cause mortality, hospital-acquired pneumonia, intubation/reintubation (days of intubation), intensive care unit admission/transfers, patient comfort and hospital length of stay. The important outcomes are: delirium, 30-day hospital readmissions, barotrauma, compromised nutrition (enteral or parenteral nutrition), gastric dysfunction, functional independence at discharge and skin breakdown or pressure ulcers. We will calculate risk ratios and Peto ORs (for rare events) and corresponding 95% CIs for categorical outcomes. Mean and standardised mean difference will be calculated for continuous outcomes. Where possible and appropriate, meta-analysis will be performed for each outcome. CONCLUSION:This systematic review will provide a comprehensive evaluation of the evidence regarding the comparative effectiveness and harms of HFNO compared with NIV or COT for the management of ARF in hospitalised adult patients to inform clinical practice and to identify research gaps in the management of ARF in hospitalised adults. The results will inform the work of the American College of Physicians-Clinical Guidelines Committee in their development of a clinical guideline related to use of HFNO in adult patients with ARF. ETHICS AND DISSEMINATION:No ethical approval will be needed because we will be using data from previously published studies in which informed consent was obtained by the primary investigators. We will publish our results in a peer-reviewed journal. PROSPERO REGISTRATION NUMBER:CRD42019146691.

SUBMITTER: Baldomero AK

PROVIDER: S-EPMC7044882 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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Effectiveness and harms of high-flow nasal oxygen (HFNO) for acute respiratory failure: a systematic review protocol.

Baldomero Arianne K AK Melzer Anne A Greer Nancy N Majeski Brittany N BN Macdonald Roderick R Wilt Timothy J TJ

BMJ open 20200212 2

<h4>Introduction</h4>High-flow nasal oxygen (HFNO) use in adults hospitalised with acute respiratory failure (ARF) is increasing. However, evidence to support widespread use of HFNO compared with non-invasive ventilation (NIV) and conventional oxygen therapy (COT) is unclear. This protocol describes the methods for a systematic evidence review regarding the comparative effectiveness and harms of HFNO compared with NIV or COT for the management of ARF in hospitalised adult patients.<h4>Methods an ...[more]

PMID: 32051320

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Project description:BACKGROUND:Acute respiratory failure (ARF) is the leading reason for intensive care unit (ICU) admission in immunocompromised patients. High-flow nasal oxygen (HFNO) therapy is an alternative to standard oxygen. By providing warmed and humidified gas, HFNO allows the delivery of higher flow rates via nasal cannula devices, with FiO2 values of nearly 100%. Benefits include alleviation of dyspnea and discomfort, decreased respiratory distress and decreased mortality in unselected patients with acute hypoxemic respiratory failure. However, in preliminary reports, HFNO benefits are controversial in immunocompromised patients in whom it has never been properly evaluated. METHODS/DESIGN:This is a multicenter, open-label, randomized controlled superiority trial in 30 intensive care units, part of the Groupe de Recherche Respiratoire en Réanimation Onco-Hématologique (GRRR-OH). Inclusion criteria will be: (1) adults, (2) known immunosuppression, (3) ARF, (4) oxygen therapy ≥ 6 L/min, (5) written informed consent from patient or proxy. Exclusion criteria will be: (1) imminent death (moribund patient), (2) no informed consent, (3) hypercapnia (PaCO2 ≥ 50 mmHg), (4) isolated cardiogenic pulmonary edema, (5) pregnancy or breastfeeding, (6) anatomical factors precluding insertion of a nasal cannula, (7) no coverage by the French statutory healthcare insurance system, and (8) post-surgical setting from day 1 to day 6 (patients with ARF occurring after day 6 of surgery can be included). The primary outcome measure is day-28 mortality. Secondary outcomes are intubation rate, comfort, dyspnea, respiratory rate, oxygenation, ICU length of stay, and ICU-acquired infections. Based on an expected 30% mortality rate in the standard oxygen group, and 20% in the HFNO group, error rate set at 5%, and a statistical power at 90%, 389 patients are required in each treatment group (778 patients overall). Recruitment period is estimated at 30 months, with 28 days of additional follow-up for the last included patient. DISCUSSION:The HIGH study will be the largest multicenter, randomized controlled trial seeking to demonstrate that survival benefits from HFNO reported in unselected patients also apply to a large immunocompromised population. TRIAL REGISTRATION:ClinicalTrials.gov, ID: NCT02739451 . Registered on 15 April 2016.

Project description:BackgroundWe performed a systematic review and meta-analysis to evaluate the efficacy and safety of high-flow oxygen via nasal cannulae (HFNC) compared to non-invasive ventilation (NIV) and/or standard oxygen in patients with acute, hypoxemic respiratory failure.MethodsWe reviewed randomized controlled trials from CENTRAL, EMBASE, MEDLINE, Scopus and the International Clinical Trials Registry Platform (inception to February 2016), conference proceedings, and relevant article reference lists. Two reviewers independently screened and extracted trial-level data from trials investigating HFNC in patients with acute, hypoxemic respiratory failure. Internal validity was assessed in duplicate using the Cochrane Risk of Bias tool. The strength of evidence was assessed in duplicate using the Grading of Recommendations Assessment, Development and Evaluation framework. Our primary outcome was mortality. Secondary outcomes included dyspnea, PaO2:FiO2 ratio, PaCO2, and pH. Safety outcomes included respiratory arrest, intubation, delirium, and skin breakdown.ResultsFrom 2023 screened citations, we identified seven trials (1771 patients) meeting inclusion criteria. All trials were at high risk of bias due to lack of blinding. There was no evidence for a mortality difference in patients receiving HFNC vs. NIV and/or standard oxygen (RR 1.01, 95% CI 0.69 to 1.48, I 2 = 63%, five trials, 1629 patients). In subgroup analyses of HFNC compared to NIV or standard oxygen individually, mortality differences were not observed. Measures of patient tolerability were heterogeneous. The PaO2:FiO2 ratio at 6-12 h was significantly lower in patients receiving oxygen via HFNC compared to NIV or standard oxygen for hypoxemic respiratory failure (MD - 53.34, 95% CI - 71.95 to - 34.72, I 2 = 61%, 1143 patients). There were no differences in pH, PaCO2, or rates of intubation or cardio-respiratory arrest. Delirium and skin breakdown were infrequently reported in included trials.ConclusionsIn patients with acute hypoxemic respiratory failure HFNC was not associated with a difference in mortality compared to NIV or standard oxygen. Secondary outcomes including dyspnea, tolerance, and safety were not systematically reported. Residual heterogeneity and variable reporting of secondary outcomes limit the conclusions that can be made in this review. Prospective trials designed to evaluate the efficacy and safety of HFNC in patients with acute hypoxemic respiratory failure are required.

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Effectiveness and harms of high-flow nasal oxygen (HFNO) for acute respiratory failure: a systematic review protocol.

Publications

Effectiveness and harms of high-flow nasal oxygen (HFNO) for acute respiratory failure: a systematic review protocol.

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