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Home Non Invasive Ventilation (NIV) treatment for COPD patients with a history of NIV-treated exacerbation; a randomized, controlled, multi-center study.

ABSTRACT: BACKGROUND:In chronic obstructive pulmonary disease, the prognosis for patients who have survived an episode of acute hypercapnic respiratory failure due to an exacerbation is poor. Despite being shown to improve survival and quality-of-life in stable patients with chronic hypercapnic respiratory failure, long-term noninvasive ventilation is controversial in unstable patients with frequent exacerbations, complicated by acute hypercapnic respiratory failure. In an uncontrolled group of patients with previous episodes of acute hypercapnic respiratory failure, treated with noninvasive ventilation, we have been able to reduce mortality and the number of repeat respiratory failure and readmissions by continuing the acute noninvasive ventilatory therapy as a long-term therapy. METHODS:Multi-center open label randomized controlled trial of 150 patients having survived an admission with noninvasive ventilatory treatment of acute hypercapnic respiratory failure due chronic obstructive pulmonary disease. The included patients are randomized to usual care or to continuing the acute noninvasive ventilation as a long-term therapy, both with a one-year follow-up period. The primary endpoint is time to death or repeat acute hypercapnic respiratory failure; secondary endpoints are one-year mortality, number of readmissions and repeat acute hypercapnic respiratory failure, exacerbations, dyspnea, quality of life, sleep quality, lung function, and arterial gases. DISCUSSION:Though previous studies of long-term noninvasive ventilation have shown conflicting results, we believe the treatment can reduce mortality and readmissions when applied in patients with previous need of acute ventilatory support, regardless of persistent hypercapnia. TRIAL REGISTRATION:clinicaltrials.org: NCT01513655 16-Jan-2012.

SUBMITTER: Ankjærgaard KL

PROVIDER: S-EPMC4751632 | biostudies-literature | 2016 Feb

REPOSITORIES: biostudies-literature

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Home Non Invasive Ventilation (NIV) treatment for COPD patients with a history of NIV-treated exacerbation; a randomized, controlled, multi-center study.

Ankjærgaard Kasper Linde KL Tønnesen Philip P Laursen Lars Christian LC Hansen Ejvind Frausing EF Andreassen Helle Frost HF Wilcke Jon Torgny JT

BMC pulmonary medicine 20160212

<h4>Background</h4>In chronic obstructive pulmonary disease, the prognosis for patients who have survived an episode of acute hypercapnic respiratory failure due to an exacerbation is poor. Despite being shown to improve survival and quality-of-life in stable patients with chronic hypercapnic respiratory failure, long-term noninvasive ventilation is controversial in unstable patients with frequent exacerbations, complicated by acute hypercapnic respiratory failure. In an uncontrolled group of pa ...[more]

PMID: 26867542

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Project description:ImportanceOutcomes after exacerbations of chronic obstructive pulmonary disease (COPD) requiring acute noninvasive ventilation (NIV) are poor and there are few treatments to prevent hospital readmission and death.ObjectiveTo investigate the effect of home NIV plus oxygen on time to readmission or death in patients with persistent hypercapnia after an acute COPD exacerbation.Design, setting, and participantsA randomized clinical trial of patients with persistent hypercapnia (Paco2 >53 mm Hg) 2 weeks to 4 weeks after resolution of respiratory acidemia, who were recruited from 13 UK centers between 2010 and 2015. Exclusion criteria included obesity (body mass index [BMI] >35), obstructive sleep apnea syndrome, or other causes of respiratory failure. Of 2021 patients screened, 124 were eligible.InterventionsThere were 59 patients randomized to home oxygen alone (median oxygen flow rate, 1.0 L/min [interquartile range {IQR}, 0.5-2.0 L/min]) and 57 patients to home oxygen plus home NIV (median oxygen flow rate, 1.0 L/min [IQR, 0.5-1.5 L/min]). The median home ventilator settings were an inspiratory positive airway pressure of 24 (IQR, 22-26) cm H2O, an expiratory positive airway pressure of 4 (IQR, 4-5) cm H2O, and a backup rate of 14 (IQR, 14-16) breaths/minute.Main outcomes and measuresTime to readmission or death within 12 months adjusted for the number of previous COPD admissions, previous use of long-term oxygen, age, and BMI.ResultsA total of 116 patients (mean [SD] age of 67 [10] years, 53% female, mean BMI of 21.6 [IQR, 18.2-26.1], mean [SD] forced expiratory volume in the first second of expiration of 0.6 L [0.2 L], and mean [SD] Paco2 while breathing room air of 59 [7] mm Hg) were randomized. Sixty-four patients (28 in home oxygen alone and 36 in home oxygen plus home NIV) completed the 12-month study period. The median time to readmission or death was 4.3 months (IQR, 1.3-13.8 months) in the home oxygen plus home NIV group vs 1.4 months (IQR, 0.5-3.9 months) in the home oxygen alone group, adjusted hazard ratio of 0.49 (95% CI, 0.31-0.77; P = .002). The 12-month risk of readmission or death was 63.4% in the home oxygen plus home NIV group vs 80.4% in the home oxygen alone group, absolute risk reduction of 17.0% (95% CI, 0.1%-34.0%). At 12 months, 16 patients had died in the home oxygen plus home NIV group vs 19 in the home oxygen alone group.Conclusions and relevanceAmong patients with persistent hypercapnia following an acute exacerbation of COPD, adding home noninvasive ventilation to home oxygen therapy prolonged the time to readmission or death within 12 months.Trial registrationclinicaltrials.gov Identifier: NCT00990132.

Project description:Background: Although an increasing number of studies have reported that telemonitoring (TM) in patients with chronic obstructive pulmonary disease (COPD) can be useful and efficacious for hospitalizations and quality of life, its actual utility in detecting and managing acute exacerbation of COPD (AECOPD) is less established. This meta-analysis aimed to identify the best available evidence on the effectiveness of TM targeting the early and optimized management of AECOPD in patients with a history of past AECOPD compared with a control group without TM intervention. Methods: We systematically searched PubMed, Embase, and the Cochrane Library for randomized controlled trials published from 1990 to May 2020. Primary endpoints included emergency room visits and exacerbation-related readmissions. P-values, risk ratios, odds ratios, and mean differences with 95% confidence intervals were calculated. Results: Of 505 identified citations, 17 original articles with both TM intervention and a control group were selected for the final analysis (N = 3,001 participants). TM was found to reduce emergency room visits [mean difference (MD) -0.70, 95% confidence interval (CI) -1.36 to -0.03], exacerbation-related readmissions (risk ratio 0.74, 95% CI 0.60-0.92), exacerbation-related hospital days (MD -0.60, 95% CI -1.06 to -0.13), mortality (odds ratio 0.71, 95% CI 0.54-0.93), and the St. George's Respiratory Questionnaire (SGRQ) score (MD -3.72, 95% CI -7.18 to -0.26) but did not make a difference with respect to all-cause readmissions, the rate of exacerbation-related readmissions, all-cause hospital days, time to first hospital readmission, anxiety and depression, and exercise capacity. Furthermore, the subgroup analysis by observation period showed that longer TM (≥12 months) was more effective in reducing readmissions. Conclusions: TM can reduce emergency room visits and exacerbation-related readmissions, as well as acute exacerbation (AE)-related hospital days, mortality, and the SGRQ score. The implementation of TM intervention is thus a potential protective therapeutic strategy that could facilitate the long-term management of AECOPD. Systematic Review Registration: This systematic review and meta-analysis is reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) Statement and was registered at International Prospective Register of Systematic Reviews (number: CRD42020181459).

Dataset Information

Home Non Invasive Ventilation (NIV) treatment for COPD patients with a history of NIV-treated exacerbation; a randomized, controlled, multi-center study.

Publications

Home Non Invasive Ventilation (NIV) treatment for COPD patients with a history of NIV-treated exacerbation; a randomized, controlled, multi-center study.

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