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      Non-invasive ventilation with pursed lips breathing mode for patients with COPD and hypercapnic respiratory failure: A retrospective analysis

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          Abstract

          Purpose

          Long-term non-invasive ventilation (NIV) is recommended for patients with stable chronic obstructive lung disease (COPD) and chronic hypercapnia. High inspiratory pressure NIV (hiNIV) and a significant reduction of arterial pCO 2 have been shown to prolong survival. Often, patients on hiNIV describe severe respiratory distress, known as “deventilation syndrome”, after removal of the NIV mask in the morning. Mechanical pursed lips breathing ventilation (PLBV) is a new non-invasive ventilation mode that mimics the pressure-curve of pursed lips breathing during expiration. The clinical impact of switching patients from standard NIV to PLBV has not been studied so far.

          Patients and methods

          In this hypothesis generating study, we retrospectively analysed the effects of switching COPD patients (stage GOLD III-IV) from conventional NIV to PLBV. Medical records of all patients who had an established NIV and were switched to PLBV between March 2016 and October 2017 were screened. Patients were included if they complained of shortness of breath on mask removal, used their conventional NIV regularly, and had a documented complete diagnostic workup including lung function testing, blood gas analysis and 6-minute walk test (6MWT) before and after 3–7 days of PLBV.

          Results

          Six male and 10 female patients (median age 65.4 years; IQR 64.0–71.3) with a previous NIV treatment duration of 38 months (median; IQR 20–42) were analysed. After PLVB initiation, the median inspiratory ventilation pressure needed to maintain the capillary pre-switch pCO 2 level was reduced from 19.5 mbar (IQR 16.0–26.0) to 13.8 mbar (IQR 12.5–14.9; p<0.001). The median 6MWT distance increased from 200m (IQR 153.8–266.3) to 270m (IQR 211.3–323.8; p<0.001). Median forced vital capacity (FVC) increased from 49.5% to 53.0% of the predicted value (p = 0.04), while changes in FEV 1 and residual volume (RV) were non-significant.

          Conclusion

          Based on this small retrospective analysis, we hypothesise that switching patients with COPD GOLD III-IV and chronic hypercapnia from conventional NIV to PLBV may increase exercise tolerance and FVC in the short term.

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          Most cited references12

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          High-intensity versus low-intensity non-invasive ventilation in patients with stable hypercapnic COPD: a randomised crossover trial.

          The conventional approach of low-intensity non-invasive positive pressure ventilation (NPPV) produces only minimal physiological and clinical benefits in patients with stable hypercapnic chronic obstructive pulmonary disease (COPD). To determine whether the novel approach of high-intensity NPPV is superior to low-intensity NPPV in controlling nocturnal hypoventilation. A randomised controlled crossover trial comparing 6 weeks of high-intensity NPPV (using controlled ventilation with mean inspiratory pressures of 28.6+/-1.9 mbar) with low-intensity NPPV (using assisted ventilation with mean inspiratory pressures of 14.6+/-0.8 mbar) was performed in 17 patients with severe stable hypercapnic COPD. Two patients refused low-intensity NPPV and two patients dropped out while on low-intensity NPPV. Thirteen patients (mean forced expiratory volume in 1 s (FEV(1)) 0.76+/-0.29 l) completed the trial. High-intensity NPPV produced higher pneumotachographically-measured expiratory volumes, with a mean treatment effect of 96 ml (95% CI 23 to 169) (p=0.015). This resulted in a mean treatment effect on nocturnal arterial carbon dioxide tension (Paco(2)) of -9.2 mm Hg (95% CI -13.7 to -4.6) (p=0.001) in favour of high-intensity NPPV. Daily use of NPPV was increased in high-intensity NPPV compared with low-intensity NPPV, with a mean difference of 3.6 h/day (95% CI 0.6 to 6.7) (p=0.024). In addition, compared with baseline, only high-intensity NPPV resulted in significant improvements in exercise-related dyspnoea, daytime Paco(2), FEV(1), vital capacity and the Severe Respiratory Insufficiency Questionnaire Summary Score. High-intensity NPPV is better tolerated by patients with severe chronic hypercapnic COPD and has been shown to be superior to the conventional and widely-used form of low-intensity NPPV in controlling nocturnal hypoventilation. High-intensity NPPV therefore offers a new promising therapeutic option for these patients.
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            The Italian multicentre study on noninvasive ventilation in chronic obstructive pulmonary disease patients.

            Chronic obstructive pulmonary disease (COPD) patients with chronic ventilatory failure (CVF) are more likely to develop exacerbations, which are an important determinant of health-related quality of life (HRQL). Long-term noninvasive positive-pressure ventilation (NPPV) has been proposed in addition to long-term oxygen therapy (LTOT) to treat CVF but little information is available on its effects on HRQL and resource consumption. Therefore, the current authors undertook a 2-yr multicentric, prospective, randomised, controlled trial to assess the effect of NPPV+ LTOT on: 1) severity of hypercapnia; 2) use of healthcare resources, and 3) HRQL, in comparison with LTOT alone. One hundred and twenty-two stable hypercapnic COPD patients on LTOT for > or = 6 months were consecutively enrolled. After inclusion and 1-month run-in, 90 patients were randomly assigned to NPPV+LTOT (n=43) or to LTOT alone (n=47). Arterial blood gases, hospital and intensive care unit (ICU) admissions, total hospital and ICU length of stay and HRQL were primary outcome measures; survival and drop-out rates, symptoms (dyspnoea and sleep quality) and exercise tolerance were secondary outcome measures. Follow-up was performed at 3-month intervals up to 2 yrs. Lung function, inspiratory muscle function, exercise tolerance and sleep quality score did not change over time in either group. By contrast the carbon dioxide tension in arterial blood on usual oxygen, resting dyspnoea and HRQL, as assessed by the Maugeri Foundation Respiratory Failure Questionnaire, changed differently over time in the two groups in favour of NPPV+LTOT. Hospital admissions were not different between groups during the follow-up. Nevertheless, overall hospital admissions showed a different trend to change in the NPPV+LTOT (decreasing by 45%) as compared with the LTOT group (increasing by 27%) when comparing the follow-up with the follow-back periods. ICU stay decreased over time by 75% and 20% in the NPPV+LTOT and LTOT groups, respectively. Survival was similar. Compared with long-term oxygen therapy alone, the addition of noninvasive positive-pressure ventilation to long-term oxygen therapy in stable chronic obstructive pulmonary disease patients with chronic ventilatory failure: 1) slightly decreased the trend to carbon dioxide retention in patients receiving oxygen at home and 2) improved dyspnoea and health-related quality of life. The results of this study show some significant benefits with the use of nocturnal, home noninvasive positive-pressure ventilation in patients with chronic ventilatory failure due to advanced chronic obstructive pulmonary disease patients. Further work is required to evaluate the effect of noninvasive positive-pressure ventilation on reducing the frequency and severity of chronic obstructive pulmonary disease exacerbation.
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              European Respiratory Society Guideline on Long-term Home Non-Invasive Ventilation for Management of Chronic Obstructive Pulmonary Disease

              While the role of acute non-invasive ventilation (NIV) has been shown to improve outcome in acute life-threatening hypercapnic respiratory failure in chronic obstructive pulmonary disease (COPD), the evidence of clinical efficacy of long-term home NIV (LTH-NIV) for management of COPD is less. This document provides evidence-based recommendations for the clinical application of LTH-NIV in chronic hypercapnic COPD patients. The European Respiratory Society Task Force (TF) committee was composed of clinicians, methodologists and experts in the field of LTH-NIV. The committee developed recommendations based on the GRADE (Grading, Recommendation, Assessment, Development and Evaluation) methodology. The GRADE Evidence to Decision framework was used to formulate recommendations. A number of topics were addressed under a narrative format which provides a useful context for clinicians and patients. The TF committee delivered conditional recommendations for four actionable PICO (target population-intervention-comparator-outcome) questions, 1) suggesting for the use of LTH-NIV in stable hypercapnic COPD; 2) suggesting for the use of LTH-NIV in COPD patients following a COPD exacerbation requiring acute NIV 3) suggesting for the use of NIV settings targeting a reduction in carbon dioxide and 4) suggesting for using fixed pressure support as first choice ventilator mode. Managing hypercapnia may be an important intervention for improving the health outcome of COPD patients with chronic respiratory failure. The TF conditionally supports the application of LTH-NIV to improve health outcome by targeting a reduction in carbon dioxide in COPD patients with persistent hypercapnic respiratory failure. These recommendations should be applied in clinical practice by practitioners that routinely care for chronic hypercapnic COPD patients.
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                Author and article information

                Contributors
                Role: ConceptualizationRole: Data curationRole: Project administrationRole: Writing – original draft
                Role: Formal analysisRole: Writing – review & editing
                Role: Data curationRole: Project administration
                Role: Data curationRole: MethodologyRole: Writing – review & editing
                Role: ConceptualizationRole: Funding acquisitionRole: InvestigationRole: MethodologyRole: SupervisionRole: Writing – review & editing
                Role: Data curationRole: InvestigationRole: Project administrationRole: SupervisionRole: VisualizationRole: Writing – review & editing
                Role: ConceptualizationRole: Formal analysisRole: InvestigationRole: MethodologyRole: VisualizationRole: Writing – original draftRole: Writing – review & editing
                Role: Editor
                Journal
                PLoS One
                PLoS ONE
                plos
                plosone
                PLoS ONE
                Public Library of Science (San Francisco, CA USA )
                1932-6203
                21 September 2020
                2020
                : 15
                : 9
                : e0238619
                Affiliations
                [1 ] Medical Clinic, Research Center Borstel, Leibniz Lung Center, Borstel, Germany
                [2 ] German Center for Infection Research (DZIF), Borstel, Hamburg, Lübeck, Riems, Germany
                [3 ] Division of Clinical Infectious Diseases, Research Centre Borstel, Borstel, Germany
                [4 ] Respiratory Medicine & International Health, University of Lübeck, Lübeck, Germany
                [5 ] Airway Research Center North (ARCN), German Center for Lung Research (DZL), Giessen, Germany
                [6 ] BioMaterialBank Nord, Research Center Borstel - Leibniz Lung Center, Borstel, Germany
                [7 ] Department of Medicine, Karolinska Institute, Stockholm, Sweden
                Srebrnjak Children's Hospital, CROATIA
                Author notes

                Competing Interests: SR invented the PLBV and has co-developed the Vigaro within the scope of a consulting contract with FLO medical. CL reports personal fees from Chiesi, Gilead, Janssen, Lucane, Novartis, Oxoid, Berlin Chemie and Thermofisher outside the submitted work. CH reports personal fees from Janssen outside the submitted work. CJ, KIG and LK have no conflicting interests to declare. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

                Author information
                http://orcid.org/0000-0002-2421-3495
                Article
                PONE-D-20-16968
                10.1371/journal.pone.0238619
                7505421
                32956395
                c2914f3d-57e8-42d4-9245-8ea6e9df4ef4
                © 2020 Jünger et al

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                : 4 June 2020
                : 20 August 2020
                Page count
                Figures: 6, Tables: 2, Pages: 12
                Funding
                Funded by: funder-id http://dx.doi.org/10.13039/501100001664, Leibniz-Gemeinschaft;
                Award ID: Open Access Publikationsfonds
                Award Recipient :
                Fees for open access publishing were covered by a grant of the German Leibniz-Gemeinschaft, Open Access Publikation Fonds to Dr Christian Herzmann. The BioMaterialBank Nord is supported by the German Center for Lung Research. The BioMaterialBank Nord is a member of popgen 2.0 network (P2N). The funder had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. The other authors received no specific funding for this work.
                Categories
                Research Article
                Medicine and Health Sciences
                Pulmonology
                Chronic Obstructive Pulmonary Disease
                Medicine and Health Sciences
                Medical Conditions
                Respiratory Disorders
                Dyspnea
                Medicine and Health Sciences
                Pulmonology
                Respiratory Disorders
                Dyspnea
                Medicine and Health Sciences
                Pulmonology
                Pulmonary Function
                Biology and Life Sciences
                Physiology
                Physiological Processes
                Respiration
                Breathing
                Physical Sciences
                Chemistry
                Chemical Elements
                Oxygen
                Medicine and Health Sciences
                Clinical Medicine
                Signs and Symptoms
                Hypercapnia
                Biology and Life Sciences
                Anatomy
                Body Fluids
                Blood
                Medicine and Health Sciences
                Anatomy
                Body Fluids
                Blood
                Biology and Life Sciences
                Physiology
                Body Fluids
                Blood
                Physical Sciences
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                Analytical Chemistry
                Chemical Analysis
                Gas Analysis
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                All relevant data are within the manuscript and its Supporting Information files.

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