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      A randomised controlled trial of non-invasive ventilation compared with extracorporeal carbon dioxide removal for acute hypercapnic exacerbations of chronic obstructive pulmonary disease

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          Abstract

          Background

          Patients presenting with acute hypercapnic respiratory failure due to exacerbations of chronic obstructive pulmonary disease (AECOPD) are typically managed with non-invasive ventilation (NIV). The impact of low-flow extracorporeal carbon dioxide removal (ECCO 2R) on outcome in these patients has not been explored in randomised trials.

          Methods

          Open-label randomised trial comparing NIV (NIV arm) with ECCO 2R (ECCO 2R arm) in patients with AECOPD at high risk of NIV failure (pH < 7.30 after ≥ 1 h of NIV). The primary endpoint was time to cessation of NIV. Secondary outcomes included device tolerance and complications, changes in arterial blood gases, hospital survival.

          Results

          Eighteen patients (median age 67.5, IQR (61.5–71) years; median GOLD stage 3 were enrolled (nine in each arm). Time to NIV discontinuation was shorter with ECCO 2R (7:00 (6:18–8:30) vs 24:30 (18:15–49:45) h, p = 0.004). Arterial pH was higher with ECCO 2R at 4 h post-randomisation (7.35 (7.31–7.37) vs 7.25 (7.21–7.26), p < 0.001). Partial pressure of arterial CO 2 (PaCO 2) was significantly lower with ECCO 2R at 4 h (6.8 (6.2–7.15) vs 8.3 (7.74–9.3) kPa; p = 0.024). Dyspnoea and comfort both rapidly improved with commencement of ECCO 2R. There were no severe or life-threatening complications in the study population. There were no episodes of major bleeding or red blood cell transfusion in either group. ICU and hospital length of stay were longer with ECCO 2R, and there was no difference in 90-day mortality or functional outcomes at follow-up.

          Interpretation

          There is evidence of benefit associated with ECCO 2R with time to improvement in respiratory acidosis, in respiratory physiology and an immediate improvement in patient comfort and dyspnoea with commencement of ECCO 2R. In addition, there was minimal clinically significant adverse events associated with ECCO 2R use in patients with AECOPD at risk of failing or not tolerating NIV. However, the ICU and hospital lengths of stay were longer in the ECCO 2R for similar outcomes.

          Trial registration The trial is prospectively registered on ClinicalTrials.gov: NCT02086084. Registered on 13th March 2014, https://clinicaltrials.gov/ct2/show/NCT02086084?cond=ecco2r&draw=2&rank=8

          Supplementary Information

          The online version contains supplementary material available at 10.1186/s13613-022-01006-8.

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          Most cited references33

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          Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients.

          Summary. A variety of definitions of major bleeding have been used in published clinical studies, and this diversity adds to the difficulty in comparing data between trials and in performing meta-analyses. In the first step towards unified definitions of bleeding complications, the definition of major bleeding in non-surgical patients was discussed at the Control of Anticoagulation Subcommittee of the International Society on Thrombosis and Haemostasis. Arising from that discussion, a definition was developed that should be applicable to studies with all agents that interfere with hemostasis, including anticoagulants, platelet function inhibitors and fibrinolytic drugs. The definition and the text that follows have been reviewed and approved by the cochairs of the subcommittee and the revised version is published here. The intention is to also seek approval of this definition from the regulatory authorities.
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            Development and first validation of the COPD Assessment Test.

            There is need for a validated short, simple instrument to quantify chronic obstructive pulmonary disease (COPD) impact in routine practice to aid health status assessment and communication between patient and physician. Current health-related quality of life questionnaires provide valid assessment of COPD, but are complex, which limits routine use. The aim of the present study was to develop a short validated patient-completed questionnaire, the COPD Assessment Test (CAT), assessing the impact of COPD on health status. 21 candidate items identified through qualitative research with COPD patients were used in three prospective international studies (Europe and the USA, n = 1,503). Psychometric and Rasch analyses identified eight items fitting a unidimensional model to form the CAT. Items were tested for differential functioning between countries. Internal consistency was excellent: Cronbach's alpha = 0.88. Test re-test in stable patients (n = 53) was very good (intra-class correlation coefficient 0.8). In the sample from the USA, the correlation with the COPD-specific version of the St George's Respiratory Questionnaire was r = 0.80. The difference between stable (n = 229) and exacerbation patients (n = 67) was five units of the 40-point scale (12%; p<0.0001). The CAT is a short, simple questionnaire for assessing and monitoring COPD. It has good measurement properties, is sensitive to differences in state and should provide a valid, reliable and standardised measure of COPD health status with worldwide relevance.
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              Valuing health‐related quality of life: An EQ ‐5 D ‐5 L value set for E ngland

              Abstract A new version of the EQ‐5D, the EQ‐5D‐5L, is available. The aim of this study is to produce a value set to support use of EQ‐5D‐5L data in decision‐making. The study design followed an international research protocol. Randomly selected members of the English general public completed 10 time trade‐off and 7 discrete choice experiment tasks in face‐to‐face interviews. A 20‐parameter hybrid model was used to combine time trade‐off and discrete choice experiment data to generate values for the 3,125 EQ‐5D‐5L health states. Valuation data are available for 996 respondents. Face validity of the data has been demonstrated, with more severe health states generally given lower values. Problems with pain/discomfort and anxiety/depression received the greatest weight. Compared to the existing EQ‐5D‐3L value set, there are considerably fewer “worse than dead” states (5.1%, compared with over one third), and the minimum value is higher. Values range from −0.285 (extreme problems on all dimensions) to 0.950 (for health states 11211 and 21111). Results have important implications for users of the EQ‐5D‐5L both in England and internationally. Quality‐adjusted life year gains from interventions seeking to improve very poor health may be smaller using this value set and may previously have been overestimated.
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                Author and article information

                Contributors
                nicholas.barrett@gstt.nhs.uk
                Nicholas.Hart@gstt.nhs.uk
                Kathleen.Daly@gstt.nhs.uk
                Martina.Marotti@gstt.nhs.uk
                ekostakou@yahoo.com
                Christopher.Carlin@ggc.scot.nhs.uk
                stephanie.lua@ggc.scot.nhs.uk
                suveer.singh@imperial.ac.uk
                andrew.bentley@mft.nhs.uk
                abdel.douiri@kcl.ac.uk
                Luigi.Camporota@gstt.nhs.uk
                Journal
                Ann Intensive Care
                Ann Intensive Care
                Annals of Intensive Care
                Springer International Publishing (Cham )
                2110-5820
                21 April 2022
                21 April 2022
                2022
                : 12
                : 36
                Affiliations
                [1 ]GRID grid.451052.7, ISNI 0000 0004 0581 2008, Department of Critical Care, , NHS Foundation Trust, ; Guy’s and St ThomasWestminster Bridge Rd, London, SE1 7EH UK
                [2 ]GRID grid.13097.3c, ISNI 0000 0001 2322 6764, Centre for Human & Applied Physiological Sciences (CHAPS), School of Basic & Medical Biosciences, Faculty of Life Sciences & Medicine, , King’s College London, ; London, WC2R 2LS UK
                [3 ]GRID grid.420545.2, ISNI 0000 0004 0489 3985, Lane Fox Respiratory Unit, , Guy’s and St. Thomas’ NHS Foundation Trust, ; Westminster Bridge Rd, London, SE1 7EH UK
                [4 ]GRID grid.511123.5, ISNI 0000 0004 5988 7216, Dept. of Respiratory Medicine, , Queen Elizabeth University Hospital, ; Glasgow, G51 4TF UK
                [5 ]GRID grid.439369.2, ISNI 0000 0004 0392 0021, Department of Respiratory and Critical Care Medicine, , Chelsea & Westminster Hospital, ; London, SW10 9NH UK
                [6 ]GRID grid.417286.e, ISNI 0000 0004 0422 2524, Department of Intensive Care & Respiratory Medicine, , Wythenshawe Hospital, Manchester University NHS Foundation Trust, ; Manchester, M23 9LT UK
                [7 ]GRID grid.13097.3c, ISNI 0000 0001 2322 6764, School of Population Health & Environmental Sciences, , King’s College London, ; London, WC2R 2LS UK
                [8 ]GRID grid.451056.3, ISNI 0000 0001 2116 3923, National Institute for Health Research Biomedical Research Centre, Guy’s and St. Thomas’ NHS Trust and King’s College London, ; London, WC2R 2LS UK
                Author information
                http://orcid.org/0000-0002-4641-8192
                Article
                1006
                10.1186/s13613-022-01006-8
                9021560
                35445986
                1e02b351-543b-4726-a657-7ee09cb20b00
                © The Author(s) 2022

                Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.

                History
                : 29 November 2021
                : 22 March 2022
                Funding
                Funded by: ALung
                Categories
                Research
                Custom metadata
                © The Author(s) 2022

                Emergency medicine & Trauma
                acute exacerbations of chronic obstructive pulmonary disease,aecopd,extracorporeal co2 removal,ecco2r,non-invasive ventilation,niv

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