Dataset Information

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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Publications

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:BackgroundNon-invasive ventilation (NIV) is a cornerstone in the management of acute chronic obstructive pulmonary disease (COPD) exacerbations with respiratory failure. While extensively studied in hospital settings, limited data exist on its use in the pre-hospital setting and clinical factors influencing its application. This study aimed to identify predictors of NIV use in the pre-hospital setting and to assess its association with patient-centered outcomes.MethodsThis single-center retrospective cohort study analyzed data from a pre-hospital emergency medical service registry in Geneva, Switzerland. Adult patients with a presumptive diagnosis of acute COPD exacerbation were included, spanning a control period (2007-2010, before NIV implementation) and an intervention period (2013-2017, after NIV implementation). For the primary analysis, multivariable logistic regression was used to identify predictors of NIV use during the intervention period. For the secondary analysis, coarsened exact matching balanced patients treated with NIV during the intervention period with those from the control period, followed by conditional regression analyses to assess patient-centered outcomes.ResultsAmong 270 included patients, 84 (46%) received NIV during the intervention period. Age ≥ 70 years (aOR 2.49, 95% CI 1.11, 5.76), female sex (aOR 2.48, 95% CI 1.13, 5.60), and systolic blood pressure (SBP) ≥ 140 mmHg (aOR 2.75, 95% CI 1.19, 6.62) were independent predictors associated with receiving NIV in the pre-hospital setting. In the matched cohort, pre-hospital NIV use was significantly associated with increased ICU admission rates, but was not associated with transport time, emergency department length of stay, hospital length of stay, or 28-day mortality. Sensitivity analyses demonstrated consistent results across different modeling approaches.ConclusionsAge ≥ 70 years, female sex, and SBP ≥ 140 mmHg were independent predictors associated with receiving NIV in the pre-hospital management of acute COPD exacerbation. The association between NIV use and increased ICU admissions may reflect its application in more severely ill patients. Pre-hospital NIV was not associated with short- or long-term outcomes beyond ICU admission. These findings underscore the need for prospective studies to clarify the role of pre-hospital NIV in patient outcomes.

Project description:ImportancePrevious exacerbations of chronic obstructive pulmonary disease (ECOPD) are associated with future events. For more than a decade, patients at high risk have been defined as individuals with a history of 2 or more moderate ECOPD, 1 or more severe ECOPD, or both within 12 months, and treatments have been allocated accordingly, but these cutoffs lack validation.ObjectivesTo validate ECOPD history categories by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) and explore alternative cutoffs to estimate moderate and severe ECOPD and all-cause mortality in COPD.Design, setting, and participantsThis cohort study analyzed data from patients with COPD in the German COPD and Systemic Consequences-Comorbidities Network (COSYCONET) study. Patients were recruited from September 2010 to December 2013. Analyses were conducted in September 2023 to August 2024.Main outcomes and measuresRisk of moderate and severe (ie, with hospitalization) ECOPD and all-cause mortality over a 4.5-year follow-up period were assessed using binomial logistic regressions and area under the receiver operating characteristic curves (AUROCs) with 95% CIs.ResultsAmong 2291 patients with COPD GOLD categories 1 to 4 (mean [SD] age, 65 [8] years; 1396 male [60.9%]), the mean (SD) estimated forced expiratory volume in the first second of expiration was 52.5% (18.6%). ECOPD history categories by GOLD had an AUROC of 0.63 (95% CI, 0.60-0.65) and 0.62 (95% CI, 0.58-0.66) to estimate moderate and severe ECOPD, respectively. A single previous moderate ECOPD within 12 months more accurately estimated future moderate and severe ECOPD (AUROC, 0.66; 95% CI, 0.64-0.69), and in line with GOLD, 1 previous severe ECOPD within 12 months estimated moderate and severe ECOPD (AUROC, 0.63; 95% CI, 0.60-0.67). The 4-year mortality rate was 219 patients (9.6%). Patients with 3 or more previous moderate ECOPD (odds ratio, 2.18; 95% CI, 1.27-3.72) or 1 or more previous severe ECOPD (odds ratio, 1.57; 95% CI, 1.29-1.91) within 12 months were more likely to die compared with patients without prior ECOPD.Conclusions and relevanceThis study's findings suggest a limited estimative performance of ECOPD history categories by GOLD. Novel cutoffs were suggested, categorizing patients as without exacerbations or with high-risk exacerbations based on a history of 1 or more moderate ECOPD, 1 or more severe ECOPD, or both within 12 months.

Dataset Information

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

Background

Methods

Discussion

Trial registration

Publications

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

Similar Datasets

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