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Update on clinical trials in home mechanical ventilation.

ABSTRACT: Home mechanical ventilation (HMV) is an increasingly common intervention and is initiated for a range of pathological processes, including neuromuscular disease (NMD), chronic obstructive pulmonary disease (COPD) and obesity related respiratory failure. There have been important recent data published in this area, which helps to guide practice by indicating which populations may benefit from this intervention and the optimum method of setting up and controlling sleep disordered breathing. Recent superficially conflicting data has been published regarding HMV in COPD, with a trial in post-exacerbation patients suggesting no benefit, but in stable chronic hypercapnic patients suggesting a clear and sustained mortality benefit. The two studies are critiqued and the potential reasons for the differing results are discussed. Early and small trial data is frequently contradicted with larger randomised controlled trials and this has been the case with diaphragm pacing being shown to be potentially harmful in the latest data, confirming the importance of non-invasive ventilation (NIV) in NMD such as motor neurone disease. Advances in ventilator technology have so far appeared quicker than the clinical data to support their use; although small and often unblinded, the current data suggests equivalence to standard modes of NIV, but with potential comfort benefits that may enhance adherence. The indications for NIV have expanded since its inception, with an effort to treat sleep disordered breathing as a result of chronic heart failure (HF). The SERVE-HF trial has recently demonstrated no clear advantage to this technology and furthermore detected a potentially deleterious effect, with a worsening of all cause and cardiovascular mortality in the treated group compared to controls. The review serves to provide the reader with a critical review of recent advances in the field of sleep disordered breathing and HMV.

SUBMITTER: Hodgson LE

PROVIDER: S-EPMC4739968 | biostudies-literature | 2016 Feb

REPOSITORIES: biostudies-literature

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Update on clinical trials in home mechanical ventilation.

Hodgson Luke E LE Murphy Patrick B PB

Journal of thoracic disease 20160201 2

Home mechanical ventilation (HMV) is an increasingly common intervention and is initiated for a range of pathological processes, including neuromuscular disease (NMD), chronic obstructive pulmonary disease (COPD) and obesity related respiratory failure. There have been important recent data published in this area, which helps to guide practice by indicating which populations may benefit from this intervention and the optimum method of setting up and controlling sleep disordered breathing. Recent ...[more]

PMID: 26904266

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Project description:BackgroundHome mechanical ventilation is an established treatment for chronic respiratory failure resulting in improved survival and quality of life. Technological advancement, evolving health care reimbursement systems and newly implemented national guidelines result in increased utilization worldwide. Prevalence shows great geographical variations and data on East-Central European practice has been scarce to date. The aim of the current study was to evaluate prevalence and characteristics of home mechanical ventilation in Hungary.MethodsWe conducted a nationwide study using an online survey focusing on patients receiving ventilatory support at home. The survey focused on characterization of the site (affiliation, type), experience with home mechanical ventilation, number of patients treated, indication for home mechanical ventilation (disease type), description of home mechanical ventilation (invasive/noninvasive, ventilation hours, duration of ventilation) and description of the care provided (type of follow up visits, hospitalization need, reimbursement).ResultsOur survey uncovered a total of 384 patients amounting to a prevalence of 3.9/100,000 in Hungary. 10.4% of patients received invasive, while 89.6% received noninvasive ventilation. The most frequent diagnosis was central hypopnea syndromes (60%), while pulmonary (20%), neuromuscular (11%) and chest wall disorders (7%) were less frequent indications. Daily ventilation need was less than 8?h in 74.2%, between 8 and 16?h in 15.4% and more than 16?h in 10.4% of patients reported. When comparing sites with a limited (<?50 patients) versus substantial (>?50 patients) case number, we found the former had significantly higher ratio of neuromuscular conditions, were more likely to ventilate invasively, with more than 16?h/day ventilation need and were more likely to provide home visits and readmit patients (p <?0,001).ConclusionsOur results show a reasonable current estimate and characterization of home mechanical ventilation practice in Hungary. Although a growing practice can be assumed, current prevalence is still markedly reduced compared to international data reported, the duality of current data hinting to a possible gap in diagnosis and care for more dependent patients. This points to the importance of establishing home mechanical ventilation centers, where increased experience will enable state of the art care to more dependent patients as well, increasing overall prevalence.

Project description:ImportanceDaily spontaneous breathing trials (SBTs) are the best approach to determine whether patients are ready for disconnection from mechanical ventilation, but mode and duration of SBT remain controversial.ObjectiveTo evaluate the effect of an SBT consisting of 30 minutes of pressure support ventilation (an approach that is less demanding for patients) vs an SBT consisting of 2 hours of T-piece ventilation (an approach that is more demanding for patients) on rates of successful extubation.Design, setting, and participantsRandomized clinical trial conducted from January 2016 to April 2017 among 1153 adults deemed ready for weaning after at least 24 hours of mechanical ventilation at 18 intensive care units in Spain. Follow-up ended in July 2017.InterventionsPatients were randomized to undergo a 2-hour T-piece SBT (n = 578) or a 30-minute SBT with 8-cm H2O pressure support ventilation (n = 557).Main outcome and measuresThe primary outcome was successful extubation (remaining free of mechanical ventilation 72 hours after first SBT). Secondary outcomes were reintubation among patients extubated after SBT; intensive care unit and hospital lengths of stay; and hospital and 90-day mortality.ResultsAmong 1153 patients who were randomized (mean age, 62.2 [SD, 15.7] years; 428 [37.1%] women), 1018 (88.3%) completed the trial. Successful extubation occurred in 473 patients (82.3%) in the pressure support ventilation group and 428 patients (74.0%) in the T-piece group (difference, 8.2%; 95% CI, 3.4%-13.0%; P = .001). Among secondary outcomes, for the pressure support ventilation group vs the T-piece group, respectively, reintubation was 11.1% vs 11.9% (difference, -0.8%; 95% CI, -4.8% to 3.1%; P = .63), median intensive care unit length of stay was 9 days vs 10 days (mean difference, -0.3 days; 95% CI, -1.7 to 1.1 days; P = .69), median hospital length of stay was 24 days vs 24 days (mean difference, 1.3 days; 95% CI, -2.2 to 4.9 days; P = .45), hospital mortality was 10.4% vs 14.9% (difference, -4.4%; 95% CI, -8.3% to -0.6%; P = .02), and 90-day mortality was 13.2% vs 17.3% (difference, -4.1% [95% CI, -8.2% to 0.01%; P = .04]; hazard ratio, 0.74 [95% CI, 0.55-0.99]).Conclusions and relevanceAmong patients receiving mechanical ventilation, a spontaneous breathing trial consisting of 30 minutes of pressure support ventilation, compared with 2 hours of T-piece ventilation, led to significantly higher rates of successful extubation. These findings support the use of a shorter, less demanding ventilation strategy for spontaneous breathing trials.Trial registrationClinicalTrials.gov Identifier: NCT02620358.

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Update on clinical trials in home mechanical ventilation.

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Update on clinical trials in home mechanical ventilation.

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