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Prediction of severe acute exacerbation using changes in breathing pattern of COPD patients on home noninvasive ventilation.

ABSTRACT: Introduction:Acute exacerbation of COPD (AECOPD) is associated with poor outcome. Noninvasive ventilation (NIV) is recommended to treat end-stage COPD. We hypothesized that changing breathing pattern of COPD patients on NIV could identify patients with severe AECOPD prior to admission. Methods:This is a prospective monocentric study including all patients with COPD treated with long-term home NIV. Patients were divided in two groups: a stable group in which patients were admitted for the usual respiratory review and an exacerbation group in which patients were admitted for inpatient care of severe AECOPD. Data from the ventilator were downloaded and analyzed over the course of the 10 days that preceded the admission. Results:A total of 62 patients were included: 41 (67%) in the stable group and 21 (33%) in the exacerbation group. Respiratory rate was higher in the exacerbation group than in the stable group over the 10 days preceding inclusion (18.2±0.5 vs 16.3±0.5 breaths/min, respectively) (P=0.034). For 2 consecutive days, a respiratory rate outside the interquartile limit of the respiratory rate calculated over the 4 preceding days was associated with an increased risk of severe AECOPD of 2.8 (95% CI: 1.4-5.5) (P<0.001). This assessment had the sensitivity, specificity, positive predictive, and negative predictive values of 57.1, 80.5, 60.0, and 78.6% respectively. Over the 10 days' period, a standard deviation (SD) of the daily use of NIV >1.0845 was associated with an increased risk of severe AECOPD of 4.0 (95% CI: 1.5-10.5) (P=0.001). This assessment had the sensitivity, specificity, positive predictive, and negative predictive values of 81.0, 63.4, 53.1, and 86.7%, respectively. Conclusion:Data from NIV can identify a change in breathing patterns that predicts severe AECOPD.

SUBMITTER: Blouet S

PROVIDER: S-EPMC6118244 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Prediction of severe acute exacerbation using changes in breathing pattern of COPD patients on home noninvasive ventilation.

Blouet Sophie S Sutter Jasmine J Fresnel Emeline E Kerfourn Adrien A Cuvelier Antoine A Patout Maxime M

International journal of chronic obstructive pulmonary disease 20180827

<h4>Introduction</h4>Acute exacerbation of COPD (AECOPD) is associated with poor outcome. Noninvasive ventilation (NIV) is recommended to treat end-stage COPD. We hypothesized that changing breathing pattern of COPD patients on NIV could identify patients with severe AECOPD prior to admission.<h4>Methods</h4>This is a prospective monocentric study including all patients with COPD treated with long-term home NIV. Patients were divided in two groups: a stable group in which patients were admitted ...[more]

PMID: 30214176

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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:BackgroundThere is strong evidence that noninvasive ventilation (NIV) improves the outcomes of patients hospitalized with severe COPD exacerbation, and NIV is recommended as the first-line therapy for these patients. Yet, several studies have demonstrated substantial variation in NIV use across hospitals, leading to preventable morbidity and mortality. In addition, prior studies suggested that efforts to increase NIV use in COPD need to account for the complex and interdisciplinary nature of NIV delivery and the need for team coordination. Therefore, our initial project aimed to compare two educational strategies: online education (OLE) and interprofessional education (IPE), which targets complex team-based care in NIV delivery. Due to the impact of the COVID-19 pandemic on recruitment and planned intervention, we had made several changes in the study design, statistical analysis, and implementation strategies delivery as outlined in the methods.MethodsWe originally proposed a two-arm, pragmatic, cluster, randomized hybrid implementation-effectiveness trial comparing two education strategies to improve NIV uptake in patients with severe COPD exacerbation in 20 hospitals with a low baseline rate of NIV use. Due to logistical constrains and slow recruitment, we changed the study design to an opened cohort stepped-wedge design with three steps which will allow the institutions to enroll when they are ready to participate. Only the IPE strategy will be implemented, and the education will be provided in an online virtual format. Our primary outcome will be the hospital-level risk-standardized NIV proportion for the period post-IPE training, along with the change in rate from the period prior to training. Aim 1 will compare the change over time of NIV use among patients with COPD in the step-wedged design. Aim 2 will explore the mediators' role (respiratory therapist autonomy and team functionality) on the relationship between the implementation strategies and effectiveness. Finally, in Aim 3, through interviews with providers, we will assess the acceptability and feasibility of the educational training.ConclusionThe changes in study design will result in several limitation. Most importantly, the hospitals in the three cohorts are not randomized as they enroll based on their readiness. Second, the delivery of the IPE is virtual, and it is not known if remote education is conducive to team building. However, this study will be among the first to test the impact of IPE in the inpatient setting carefully and may generalize to other interventions directed to seriously ill patients.Trial registrationClinicalTrials.gov NCT04206735 . Registered on December 20, 2019.

Project description:BackgroundThe efficacy and safety of high flow nasal therapy (HFNT) in patients with acute hypercapnic exacerbation of chronic obstructive pulmonary disease (AECOPD) are unclear. Our aim was to evaluate the short-term effect of HFNT versus NIV in patients with mild-to-moderate AECOPD, with the hypothesis that HFNT is non-inferior to NIV on CO2 clearance after 2 h of treatment.MethodsWe performed a multicenter, non-inferiority randomized trial comparing HFNT and noninvasive ventilation (NIV) in nine centers in Italy. Patients were eligible if presented with mild-to-moderate AECOPD (arterial pH 7.25-7.35, PaCO2 ≥ 55 mmHg before ventilator support). Primary endpoint was the mean difference of PaCO2 from baseline to 2 h (non-inferiority margin 10 mmHg) in the per-protocol analysis. Main secondary endpoints were non-inferiority of HFNT to NIV in reducing PaCO2 at 6 h in the per-protocol and intention-to-treat analysis and rate of treatment changes.ResultsSeventy-nine patients were analyzed (80 patients randomized). Mean differences for PaCO2 reduction from baseline to 2 h were - 6.8 mmHg (± 8.7) in the HFNT and - 9.5 mmHg (± 8.5) in the NIV group (p = 0.404). By 6 h, 32% of patients (13 out of 40) in the HFNT group switched to NIV and one to invasive ventilation. HFNT was statistically non-inferior to NIV since the 95% confidence interval (CI) upper boundary of absolute difference in mean PaCO2 reduction did not reach the non-inferiority margin of 10 mmHg (absolute difference 2.7 mmHg; 1-sided 95% CI 6.1; p = 0.0003). Both treatments had a significant effect on PaCO2 reductions over time, and trends were similar between groups. Similar results were found in both per-protocol at 6 h and intention-to-treat analysis.ConclusionsHFNT was statistically non-inferior to NIV as initial ventilatory support in decreasing PaCO2 after 2 h of treatment in patients with mild-to-moderate AECOPD, considering a non-inferiority margin of 10 mmHg. However, 32% of patients receiving HFNT required NIV by 6 h. Further trials with superiority design should evaluate efficacy toward stronger patient-related outcomes and safety of HFNT in AECOPD.Trial registrationThe study was prospectively registered on December 12, 2017, in ClinicalTrials.gov (NCT03370666).

Project description:BackgroundCOPD is the fourth leading cause of death in the US, and COPD exacerbations result in approximately 700,000 hospitalizations annually. Patients with acute respiratory failure due to severe COPD exacerbation are treated with invasive (IMV) or noninvasive mechanical ventilation (NIV). Although IMV reverses hypercapnia/hypoxia, it causes significant morbidity and mortality. There is strong evidence that patients treated with NIV have better outcomes, and NIV is recommended as first line therapy in these patients. Yet, several studies have demonstrated substantial variation in the use of NIV across hospitals, leading to preventable morbidity and mortality. Through a series of mixed-methods studies, we have found that successful implementation of NIV requires physicians, respiratory therapists (RTs), and nurses to communicate and collaborate effectively, suggesting that efforts to increase the use of NIV in COPD need to account for the complex and interdisciplinary nature of NIV delivery and the need for team coordination. Therefore, we propose to compare two educational strategies: online education (OLE) and interprofessional education (IPE) which targets complex team-based care in NIV delivery.Methods and designTwenty hospitals with low baseline rates of NIV use will be randomized to either the OLE or IPE study arm. The primary outcome of the trial is change in the hospital rate of NIV use among patients with COPD requiring ventilatory support. In aim 1, we will compare the uptake change over time of NIV use among patients with COPD in hospitals enrolled in the two arms. In aim 2, we will explore mediators' role (respiratory therapist autonomy and team functionality) on the relationship between the implementation strategies and implementation effectiveness. Finally, in aim 3, through interviews with providers, we will assess acceptability and feasibility of the educational training.DiscussionsThis study will be among the first to carefully test the impact of IPE in the inpatient setting. This work promises to change practice by offering approaches to facilitate greater uptake of NIV and may generalize to other interventions directed to seriously-ill patients.Trial registrationName of registry: ClinicalTrials.govTrial registration number: NCT04206735Date of Registration: December 20, 2019.

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Prediction of severe acute exacerbation using changes in breathing pattern of COPD patients on home noninvasive ventilation.

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Prediction of severe acute exacerbation using changes in breathing pattern of COPD patients on home noninvasive ventilation.

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