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Two-year home-based nocturnal noninvasive ventilation added to rehabilitation in chronic obstructive pulmonary disease patients: a randomized controlled trial.

ABSTRACT: The use of noninvasive intermittent positive pressure ventilation (NIPPV) in chronic obstructive pulmonary disease (COPD) patients with chronic hypercapnic respiratory failure remains controversial as long-term data are almost lacking. The aim was to compare the outcome of 2-year home-based nocturnal NIPPV in addition to rehabilitation (NIPPV + PR) with rehabilitation alone (PR) in COPD patients with chronic hypercapnic respiratory failure.Sixty-six patients could be analyzed for the two-year home-based follow-up period. Differences in change between the NIPPV + PR and PR group were assessed by a linear mixed effects model with a random effect on the intercept, and adjustment for baseline values. The primary outcome was health-related quality of life (HRQoL); secondary outcomes were mood state, dyspnea, gas exchange, functional status, pulmonary function, and exacerbation frequency.Although the addition of NIPPV did not significantly improve the Chronic Respiratory Questionnaire compared to rehabilitation alone (mean difference in change between groups -1.3 points (95% CI: -9.7 to 7.4)), the addition of NIPPV did improve HRQoL assessed with the Maugeri Respiratory Failure questionnaire (-13.4% (-22.7 to -4.2; p = 0.005)), mood state (Hospital Anxiety and Depression scale -4.0 points (-7.8 to 0.0; p = 0.05)), dyspnea (Medical Research Council -0.4 points (-0.8 to -0.0; p = 0.05)), daytime arterial blood gases (PaCO2 -0.4 kPa (-0.8 to -0.2; p = 0.01); PaO2 0.8 kPa (0.0 to 1.5; p = 0.03)), 6-minute walking distance (77.3 m (46.4 to 108.0; p < 0.001)), Groningen Activity and Restriction scale (-3.8 points (-7.4 to -0.4; p = 0.03)), and forced expiratory volume in 1 second (115 ml (19 to 211; p = 0.019)). Exacerbation frequency was not changed.The addition of NIPPV to pulmonary rehabilitation for 2 years in severe COPD patients with chronic hypercapnic respiratory failure improves HRQoL, mood, dyspnea, gas exchange, exercise tolerance and lung function decline. The benefits increase further with time.ClinicalTrials.Gov (ID NCT00135538).

SUBMITTER: Duiverman ML

PROVIDER: S-EPMC3182911 | biostudies-literature | 2011 Aug

REPOSITORIES: biostudies-literature

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Two-year home-based nocturnal noninvasive ventilation added to rehabilitation in chronic obstructive pulmonary disease patients: a randomized controlled trial.

Duiverman Marieke L ML Wempe Johan B JB Bladder Gerrie G Vonk Judith M JM Zijlstra Jan G JG Kerstjens Huib A M HA Wijkstra Peter J PJ

Respiratory research 20110823

<h4>Background</h4>The use of noninvasive intermittent positive pressure ventilation (NIPPV) in chronic obstructive pulmonary disease (COPD) patients with chronic hypercapnic respiratory failure remains controversial as long-term data are almost lacking. The aim was to compare the outcome of 2-year home-based nocturnal NIPPV in addition to rehabilitation (NIPPV + PR) with rehabilitation alone (PR) in COPD patients with chronic hypercapnic respiratory failure.<h4>Methods</h4>Sixty-six patients co ...[more]

PMID: 21861914

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Project description:ImportanceThe association of home noninvasive positive pressure ventilation (NIPPV) with outcomes in chronic obstructive pulmonary disease (COPD) and hypercapnia is uncertain.ObjectiveTo evaluate the association of home NIPPV via bilevel positive airway pressure (BPAP) devices and noninvasive home mechanical ventilator (HMV) devices with clinical outcomes and adverse events in patients with COPD and hypercapnia.Data sourcesSearch of MEDLINE, EMBASE, SCOPUS, Cochrane Central Registrar of Controlled Trials, Cochrane Database of Systematic Reviews, National Guideline Clearinghouse, and Scopus for English-language articles published from January 1, 1995, to November 6, 2019.Study selectionRandomized clinical trials (RCTs) and comparative observational studies that enrolled adults with COPD with hypercapnia who used home NIPPV for more than 1 month were included.Data extraction and synthesisData extraction was completed by independent pairs of reviewers. Risk of bias was evaluated using the Cochrane Collaboration risk of bias tool for RCTs and select items from the Newcastle-Ottawa Scale for nonrandomized studies.Main outcomes and measuresPrimary outcomes were mortality, all-cause hospital admissions, need for intubation, and quality of life at the longest follow-up.ResultsA total of 21 RCTs and 12 observational studies evaluating 51 085 patients (mean [SD] age, 65.7 [2.1] years; 43% women) were included, among whom there were 434 deaths and 27 patients who underwent intubation. BPAP compared with no device was significantly associated with lower risk of mortality (22.31% vs 28.57%; risk difference [RD], -5.53% [95% CI, -10.29% to -0.76%]; odds ratio [OR], 0.66 [95% CI, 0.51-0.87]; P = .003; 13 studies; 1423 patients; strength of evidence [SOE], moderate), fewer patients with all-cause hospital admissions (39.74% vs 75.00%; RD, -35.26% [95% CI, -49.39% to -21.12%]; OR, 0.22 [95% CI, 0.11-0.43]; P < .001; 1 study; 166 patients; SOE, low), and lower need for intubation (5.34% vs 14.71%; RD, -8.02% [95% CI, -14.77% to -1.28%]; OR, 0.34 [95% CI, 0.14-0.83]; P = .02; 3 studies; 267 patients; SOE, moderate). There was no significant difference in the total number of all-cause hospital admissions (rate ratio, 0.91 [95% CI, 0.71-1.17]; P = .47; 5 studies; 326 patients; SOE, low) or quality of life (standardized mean difference, 0.16 [95% CI, -0.06 to 0.39]; P = .15; 9 studies; 833 patients; SOE, insufficient). Noninvasive HMV use compared with no device was significantly associated with fewer all-cause hospital admissions (rate ratio, 0.50 [95% CI, 0.35-0.71]; P < .001; 1 study; 93 patients; SOE, low), but not mortality (21.84% vs 34.09%; RD, -11.99% [95% CI, -24.77% to 0.79%]; OR, 0.56 [95% CI, 0.29-1.08]; P = .49; 2 studies; 175 patients; SOE, insufficient). There was no statistically significant difference in the total number of adverse events in patients using NIPPV compared with no device (0.18 vs 0.17 per patient; P = .84; 6 studies; 414 patients).Conclusions and relevanceIn this meta-analysis of patients with COPD and hypercapnia, home BPAP, compared with no device, was associated with lower risk of mortality, all-cause hospital admission, and intubation, but no significant difference in quality of life. Noninvasive HMV, compared with no device, was significantly associated with lower risk of hospital admission, but there was no significant difference in mortality risk. However, the evidence was low to moderate in quality, the evidence on quality of life was insufficient, and the analyses for some outcomes were based on small numbers of studies.

Project description:Purpose:Pulmonary rehabilitation (PR) is a well-established treatment for chronic obstructive pulmonary disease (COPD). The standard protocol for PR requires frequent hospital visits, which can be difficult for patients. We performed this study to assess whether unsupervised home-based PR (HBPR) is effective for patients with COPD. Patients and Methods:After assessing the outcome data, including the results of a COPD assessment test (CAT); the body mass index, airflow obstruction, dyspnea, and exercise capacity (BODE) index; a spirometry; the modified Medical Research Council (mMRC) dyspnea scale; and the 6-min walking test (6MWT), specialists imparted 1-hour education to patients regarding unsupervised HBPR at the baseline visit. This included methods for breathing, inhaler use, stretching, and exercise. On reviewing diaries after 8 weeks from the first visit, patients who exercised at least thrice per week were classified as the compliant group and the others were categorized as the noncompliant group. Changes in the outcomes were compared between the compliant and noncompliant groups. Results:A total of 41 patients were enrolled in this study; for 8 weeks of unsupervised HBPR, there were significant improvements in CAT scores (-4.62±4.61 vs 2.40±6.73; P=0.002), BODE index (-1.00±1.06 vs -0.20±0.56; P=0.01), and forced expiratory volume in 1 s (0.05±0.19 vs -0.09±0.16; P=0.02) among patients in the compliant group, compared with the noncompliant group. Moreover, their CAT (16.46±7.80 vs 11.85±7.23; P=0.03) and mMRC scores (2.54±0.76 vs 1.81±0.63; P=0.001) improved significantly after 8 weeks, compared with those at baseline. On the other hand, patients in the noncompliant group showed no significant improvement in any of the outcomes. Conclusion:In this study, compliant patients with unsupervised HBPR achieved favorable outcomes in 8 weeks. Thus, we recommend unsupervised HBPR for patients with COPD, even when regular hospital visits for PR are not possible. Trial Registration:NCT03754881.

Project description:OBJECTIVES:We investigated whether patients with chronic obstructive pulmonary disease could safely receive noninvasive ventilation outside of the ICU. DESIGN:Retrospective cohort study. SETTING:Twelve states with ICU utilization flag from the State Inpatient Database from 2014. PATIENTS:Patients greater than or equal to 18 years old with primary diagnosis of acute exacerbation of chronic obstructive pulmonary disease and secondary diagnosis of respiratory failure who received noninvasive ventilation. INTERVENTIONS:None. MEASUREMENTS AND MAIN RESULTS:Multilevel logistic regression models were used to obtain hospital-level ICU utilization rates. We risk-adjusted using both patient/hospital characteristics. The primary outcome was in-hospital mortality; secondary outcomes were invasive monitoring (arterial/central catheters), hospital length of stay, and cost. We examined 5,081 hospitalizations from 424 hospitals with ICU utilization ranging from 0.05 to 0.98. The overall median in-hospital mortality was 2.62% (interquartile range, 1.72-3.88%). ICU utilization was not significantly associated with in-hospital mortality (? = 0.01; p = 0.05) or length of stay (? = 0.18; p = 0.41), which was confirmed by Spearman correlation (? = 0.06; p = 0.20 and ? = 0.02; p = 0.64, respectively). However, lower ICU utilization was associated with lower rates of invasive monitor placement by linear regression (? = 0.05; p < 0.001) and Spearman correlation (? = 0.28; p < 0.001). Lower ICU utilization was also associated with significantly lower cost by linear regression (? = 14.91; p = 0.02) but not by Spearman correlation (? = 0.09; p = 0.07). CONCLUSIONS:There is wide variability in the rate of ICU utilization for noninvasive ventilation across hospitals. Chronic obstructive pulmonary disease patients receiving noninvasive ventilation had similar in-hospital mortality across the ICU utilization spectrum but a lower rate of receiving invasive monitors and probably lower cost when treated in lower ICU-utilizing hospitals. Although the results suggest that noninvasive ventilation can be delivered safely outside of the ICU, we advocate for hospital-specific risk assessment if a hospital were considering changing its noninvasive ventilation delivery policy.

Project description:BackgroundThe use of ward-based noninvasive ventilation (NIV) for acute hypercapnic respiratory failure (AHRF) unrelated to chronic obstructive pulmonary disease (COPD) remains controversial. This study evaluated the outcomes and failure rates associated with NIV application in the ward-based setting for patients with AHRF unrelated to COPD.MethodsA multicentre, retrospective cohort study of patients with AHRF unrelated to COPD was conducted. COPD was not the main reason for hospital admission, treated with ward-based NIV between February 2004 and December 2018. All AHRF patients were eligible; exclusion criteria comprised COPD patients, age < 18 years, pre-NIV pH < 7.35, or a lack of pre-NIV blood gas. In-hospital mortality was the primary outcome; univariable and multivariable models were constructed. The obesity-related AHRF group included patients with AHRF due to obesity hypoventilation syndrome (OHS), and the non-obesity-related AHRF group included patients with AHRF due to pneumonia, bronchiectasis, neuromuscular disease, or fluid overload.ResultsIn total, 479 patients were included in the analysis; 80.2% of patients survived to hospital discharge. Obesity-related AHRF was the indication for NIV in 39.2% of all episodes and was the aetiology with the highest rate of survival to hospital discharge (93.1%). In the multivariable analysis, factors associated with a higher risk of in-hospital mortality were increased age (odds ratio, 95% CI: 1.034, 1.017-1.051, P < 0.001) and pneumonia on admission (5.313, 2.326-12.131, P < 0.001). In the obesity-related AHRF group, pre-NIV pH < 7.15 was associated with significantly increased in-hospital mortality (7.800, 1.843-33.013, P=0.005); however, a pre-NIV pH 7.15-7.25 was not associated with increased in-hospital mortality (2.035, 0.523-7.915, P=0.305).ConclusionPre-NIV pH and age have been identified as important predictors of surviving ward-based NIV treatment. Moreover, these data support the use of NIV in ward-based settings for obesity-related AHRF patients with pre-NIV pH thresholds down to 7.15. However, future controlled trials are required to confirm the effectiveness of NIV use outside critical care settings for obesity-related AHRF.

Project description:IMPORTANCE:Small clinical trials have shown that noninvasive ventilation (NIV) is efficacious in reducing the need for intubation and improving short-term survival among patients with severe exacerbations of chronic obstructive pulmonary disease (COPD). Little is known, however, about the effectiveness of NIV in routine clinical practice. OBJECTIVE:To compare the outcomes of patients with COPD treated with NIV to those treated with invasive mechanical ventilation (IMV). DESIGN, SETTING, AND PARTICIPANTS:This was a retrospective cohort study of 25?628 patients hospitalized for exacerbation of COPD who received mechanical ventilation on the first or second hospital day at 420 US hospitals participating in the Premier Inpatient Database. EXPOSURES:Initial ventilation strategy. MAIN OUTCOMES AND MEASURES:In-hospital mortality, hospital-acquired pneumonia, hospital length of stay and cost, and 30-day readmission. RESULTS:In the study population, a total of 17?978 (70%) were initially treated with NIV on hospital day 1 or 2. When compared with those initially treated with IMV, NIV-treated patients were older, had less comorbidity, and were less likely to have concomitant pneumonia present on admission. In a propensity-adjusted analysis, NIV was associated with lower risk of mortality than IMV (odds ratio [OR] 0.54; [95% CI, 0.48-0.61]). Treatment with NIV was associated with lower risk of hospital-acquired pneumonia (OR, 0.53 [95% CI, 0.44-0.64]), lower costs (ratio, 0.68 [95% CI, 0.67-0.69]), and a shorter length of stay (ratio, 0.81 [95% CI, 0.79-0.82]), but no difference in 30-day all-cause readmission (OR, 1.04 [95% CI, 0.94-1.15]) or COPD-specific readmission (OR, 1.05 [95% CI, 0.91-1.22]). Propensity matching attenuated these associations. The benefits of NIV were similar in a sample restricted to patients younger than 85 years and were attenuated among patients with higher levels of comorbidity and concomitant pneumonia. Using the hospital as an instrumental variable, the strength of association between NIV and mortality was modestly attenuated (OR, 0.66 [95% CI, 0.47-0.91]). In sensitivity analyses, the benefit of NIV was robust in the face of a strong hypothetical unmeasured confounder. CONCLUSIONS AND RELEVANCE:In a large retrospective cohort study, patients with COPD treated with NIV at the time of hospitalization had lower inpatient mortality, shorter length of stay, and lower costs compared with those treated with IMV.

Project description:RationaleNoninvasive ventilation (NIV) is a cornerstone of treatment for patients with severe exacerbations of chronic obstructive pulmonary disease (COPD), where it has been shown to reduce the need for intubation, hospital length of stay, and mortality. Despite high-quality evidence and strong recommendations in clinical guidelines, use of NIV varies widely across hospitals.ObjectivesTo identify approaches used by hospitals that have been successful in implementing NIV to treat patients with severe exacerbations of COPD.MethodsAdopting a positive deviance approach, in-depth interviews were conducted with key stakeholders from a sample of high-performing hospitals selected from a large and representative network of 386 U.S. hospitals. High performers were defined as hospitals in which a high proportion of patients with COPD requiring mechanical ventilation were treated with NIV, and that also achieved low risk-adjusted mortality for all patients with COPD. Interviews were audio-recorded and transcribed verbatim. Themes and subthemes were identified through iterative readings of the transcripts and discussion until the team agreed that all important themes and subthemes had been identified. All transcripts were coded by three or four researchers. Differences in coding were discussed to negotiate consensus, resulting in a single agreed-on set of coded transcripts.ResultsInterviews were conducted with 32 participants from seven hospitals. Hospitals were diverse regarding size, teaching status, and geographic location. Participants included respiratory therapists (n?=?15), physicians (n?=?10), and nurses (n?=?7). The qualitative analyses revealed three interrelated domains that characterized effective NIV use: processes, structural elements, and contextual factors. Several themes comprised each domain. Key processes included timely identification of appropriate patients, early initiation of NIV, frequent reassessment of patients, and attention to patient comfort. Necessary structural elements included adequate equipment, sufficient numbers of qualified respiratory therapists, and flexibility in staffing. Important contextual factors included provider buy-in, respiratory therapist autonomy, interdisciplinary teamwork, and staff education. Hospital leaders, policies, and protocols were identified as playing a supporting role in promoting essential elements.ConclusionsWe identified factors, such as respiratory therapist autonomy, that facilitated essential processes (e.g., timely initiation) of NIV use at high-performing hospitals. These findings may be useful to hospitals seeking to optimize their use of NIV among patients with COPD.

Project description:High-intensity (high-pressure and high backup rate) noninvasive ventilation has recently been advocated for the management of stable hypercapnic chronic obstructive pulmonary disease (COPD). However, the relative contributions of high inspiratory pressure and high backup rate to ventilator adherence and physiological outcome have not been investigated.Patients with stable hypercapnic COPD (daytime PaCO(2) > 6 kPa) and nocturnal hypoventilation were enrolled. Patients were randomly allocated to high-pressure and high backup rate (high-intensity) and high-pressure and low backup rate (high-pressure) for a 6-week period. At the end of the first treatment period, patients were switched to the alternative treatment. The primary outcome measure was mean nightly ventilator usage.Twelve patients were recruited, with seven completing the 12-week trial protocol. The mean patient age was 71 ± 8 years, with a forced expiratory volume in one second (FEV(1))/forced vital capacity (FVC) of 50% ± 13% and FEV(1) of 32% ± 12%. The baseline PaCO(2) and PaO(2) were 8.6 ± 1.7 kPa and 7.3 ± 1.4 kPa, respectively. There was no significant difference demonstrated in mean nightly ventilator usage between the high-intensity and high-pressure groups (difference of 4 minutes; 95% confidence interval -45 to 53; P = 0.9). Furthermore, there were no differences in any of the secondary endpoints, with the exception of the respiratory domain of the Severe Respiratory Insufficiency questionnaire, which was lower in the high-intensity arm than in the high-pressure arm (57 ± 11 versus 69 ± 16; P < 0.05).There was no additional benefit, in terms of night-time ventilator adherence or any of the other measured parameters, demonstrated by addition of a high backup rate to high-pressure noninvasive ventilation. These data suggest that it is the high-pressure component of the high-intensity noninvasive ventilation approach that plays the important therapeutic role in the management of hypercapnic respiratory failure in COPD patients.

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Two-year home-based nocturnal noninvasive ventilation added to rehabilitation in chronic obstructive pulmonary disease patients: a randomized controlled trial.

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Two-year home-based nocturnal noninvasive ventilation added to rehabilitation in chronic obstructive pulmonary disease patients: a randomized controlled trial.

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