Home noninvasive ventilation in severe COPD: in whom does it work and how?

Background: Not all hypercapnic COPD patients benefit from home noninvasive ventilation (NIV), and mechanisms through which NIV improves clinical outcomes remain uncertain. We aimed to identify "responders" to home NIV, denoted by a beneficial effect of NIV on arterial partial pressure of carbon dioxide (PaCO2), health-related quality of life (HRQoL) and survival, and investigated whether NIV achieves its beneficial effect through an improved PaCO2. Methods: We used individual patient data from previous published trials collated for a systematic review. Linear mixed-effect models were conducted to compare the effect of NIV on PaCO2, HRQoL and survival, within subgroups defined by patient and treatment characteristics. Secondly, we conducted a causal mediation analysis to investigate whether the effect of NIV is mediated by a change in PaCO2. Findings: Data of 1142 participants from 16 studies were used. Participants treated with lower pressure support (<14 versus ≥14 cmH2O) and with lower adherence (<5 versus ≥5 h·day-1) had less improvement in PaCO2 (mean difference (MD) -0.30 kPa, p<0.001 and -0.29 kPa, p<0.001, respectively) and HRQoL (standardised MD 0.10, p=0.002 and 0.11, p=0.02, respectively), but this effect did not persist to survival. PaCO2 improved more in patients with severe dyspnoea (MD -0.30, p=0.02), and HRQoL improved only in participants with fewer than three exacerbations (standardised MD 0.52, p=0.03). The results of the mediation analysis showed that the effect on HRQoL is mediated partially (23%) by a change in PaCO2. Interpretation: With greater pressure support and better daily NIV usage, a larger improvement in PaCO2 and HRQoL is achieved. Importantly, we demonstrated that the beneficial effect of home NIV on HRQoL is only partially mediated through a reduction in diurnal PaCO2.

Sex-specific associations between daytime sleepiness, chronic diseases and mortality in obstructive sleep apnea.

Objective: Excessive daytime sleepiness (EDS) is common in obstructive sleep apnea (OSA) and has been linked to adverse outcomes, albeit inconsistently. Furthermore, whether the prognostic impact of EDS differs as a function of sex is unclear. We aimed to assess the associations between EDS and chronic diseases and mortality in men and women with OSA. Methods: Newly-diagnosed adult OSA patients who underwent sleep evaluation at Mayo Clinic between November 2009 and April 2017 and completed the Epworth Sleepiness Scale (ESS) for assessment of perceived sleepiness (N = 14,823) were included. Multivariable-adjusted regression models were used to investigate the relationships between sleepiness, with ESS modeled as a binary (ESS > 10) and as a continuous variable, and chronic diseases and all-cause mortality. Results: In cross-sectional analysis, ESS > 10 was independently associated with lower risk of hypertension in male OSA patients (odds ratio [OR], 95% confidence interval [CI]: 0.76, 0.69-0.83) and with higher risk of diabetes mellitus in both OSA men (OR, 1.17, 95% CI 1.05-1.31) and women (OR 1.26, 95% CI 1.10-1.45). Sex-specific curvilinear relations between ESS score and depression and cancer were noted. After a median 6.2 (4.5-8.1) years of follow-up, the hazard ratio for all-cause death in OSA women with ESS > 10 compared to those with ESS ≤ 10 was 1.24 (95% CI 1.05-1.47), after adjusting for demographics, sleep characteristics and comorbidities at baseline. In men, sleepiness was not associated with mortality. Conclusion: The implications of EDS for morbidity and mortality risk in OSA are sex-dependent, with hypersomnolence being independently associated with greater vulnerability to premature death only in female patients. Efforts to mitigate mortality risk and restore daytime vigilance in women with OSA should be prioritized.

Society of Anesthesia and Sleep Medicine Position Paper on Patient Sleep During Hospitalization.

This article addresses the issue of patient sleep during hospitalization, which the Society of Anesthesia and Sleep Medicine believes merits wider consideration by health authorities than it has received to date. Adequate sleep is fundamental to health and well-being, and insufficiencies in its duration, quality, or timing have adverse effects that are acutely evident. These include cardiovascular dysfunction, impaired ventilatory function, cognitive impairment, increased pain perception, psychomotor disturbance (including increased fall risk), psychological disturbance (including anxiety and depression), metabolic dysfunction (including increased insulin resistance and catabolic propensity), and immune dysfunction and proinflammatory effects (increasing infection risk and pain generation). All these changes negatively impact health status and are counterproductive to recovery from illness and operation. Hospitalization challenges sleep in a variety of ways. These challenges include environmental factors such as noise, bright light, and overnight awakenings for observations, interventions, and transfers; physiological factors such as pain, dyspnea, bowel or urinary dysfunction, or discomfort from therapeutic devices; psychological factors such as stress and anxiety; care-related factors including medications or medication withdrawal; and preexisting sleep disorders that may not be recognized or adequately managed. Many of these challenges appear readily addressable. The key to doing so is to give sleep greater priority, with attention directed at ensuring that patients' sleep needs are recognized and met, both within the hospital and beyond. Requirements include staff education, creation of protocols to enhance the prospect of sleep needs being addressed, and improvement in hospital design to mitigate environmental disturbances. Hospitals and health care providers have a duty to provide, to the greatest extent possible, appropriate preconditions for healing. Accumulating evidence suggests that these preconditions include adequate patient sleep duration and quality. The Society of Anesthesia and Sleep Medicine calls for systematic changes in the approach of hospital leadership and staff to this issue. Measures required include incorporation of optimization of patient sleep into the objectives of perioperative and general patient care guidelines. These steps should be complemented by further research into the impact of hospitalization on sleep, the effects of poor sleep on health outcomes after hospitalization, and assessment of interventions to improve it.

Evaluating an under-mattress sleep monitor compared to a peripheral arterial tonometry home sleep apnea test device in the diagnosis of obstructive sleep apnea.

STUDY OBJECTIVES: To evaluate whether or not the apnea-hypopnea index (AHI) from a peripheral arterial tonometry (PAT) home sleep apnea test (HSAT) is equivalent to the AHI provided by the mean of one, three, or seven nights from the Withings Sleep Analyzer (WSA) under-mattress device. METHODS: We prospectively enrolled patients with suspected OSA in whom a PAT-HSAT was ordered. Eligible patients used the WSA for seven to nine nights. PAT data were scored using the device's intrinsic machine learning algorithms to arrive at the AHI using both 3% and 4% desaturation criteria for hypopnea estimations (PAT3%-AHI and PAT4%-AHI, respectively). These were then compared with the WSA-estimated AHI (WSA-AHI). RESULTS: Of 61 patients enrolled, 35 completed the study with valid PAT and WSA data. Of the 35 completers 16 (46%) had at least moderately severe OSA (PAT3%-AHI ≥ 15). The seven-night mean WSA-AHI was 2.13 (95%CI = - 0.88, 5.14) less than the PAT3%-AHI, but 5.64 (95%CI = 2.54, 8.73) greater than the PAT4%-AHI. The accuracy and area under the receiver operating curve (AUC) using the PAT3%-AHI ≥ 15 were 77% and 0.87 and for PAT4%-AHI ≥ 15 were 77% and 0.85, respectively. The one-, three-, or seven-night WSA-AHI were not equivalent to either the 3% or 4% PAT-AHI (equivalency threshold of ± 2.5 using the two one-sided t-test method). CONCLUSIONS: The WSA derives estimates of the AHI unobtrusively over many nights, which may prove to be a valuable clinical tool. However, the WSA-AHI over- or underestimates the PAT-AHI in clinical use, and the appropriate use of the WSA in clinical practice will require further evaluation. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04778748.

Rapid response to medical device recalls: an organized patient-centered team effort.

As more patients depend upon mechanical or electronic technologies for treatment, medical device recalls-like the recent recall of common positive airway pressure treatment devices-impact millions of patients, often causing significant anxiety, extra costs, and interruption of care for patients. When recalls require health care and/durable medical equipment providers to be part of the solution, the burden on practices and businesses can be significant, creating strains on access for new patients and on limited medical supplies. We have observed that having an established and well-organized medical device recall plan in place allows for a rapid response, decreased practice burden, and reduced provider stress. Coupling the organized response with proactive, empathic, and clear communication with patients reduces their anxiety, provides clear directions for how to address the issue constructively, and reduces reactive communications. We share what we believe are key components of a medical device and produce recall procedure as we describe our institutions response in hopes that others can build on these basics as they design their own response plans. CITATION: Morgenthaler TI, Linginfelter EA, Gay PC, et al. Rapid response to medical device recalls: an organized patient-centered team effort. J Clin Sleep Med. 2022;18(2):663-667.

Executive Summary: Optimal NIV Medicare Access Promotion: A Technical Expert Panel Report From the American College of Chest Physicians, the American Association for Respiratory Care, the American Academy of Sleep Medicine, and the American Thoracic Society.

The current national coverage determinations (NCDs) for noninvasive ventilation for patients with thoracic restrictive disorders, COPD, and hypoventilation syndromes were formulated in 1998. New original research, updated formal practice guidelines, and current consensus expert opinion have accrued that are in conflict with the existing NCDs. Some inconsistencies in the NCDs have been noted, and the diagnostic and therapeutic technology has also advanced in the last quarter century. Thus, these and related NCDs relevant to bilevel positive airway pressure for the treatment of OSA and central sleep apnea need to be updated to ensure the optimal health of patients with these disorders. To that end, the American College of Chest Physicians organized a multisociety (American Thoracic Society, American Academy of Sleep Medicine, and American Association for Respiratory Care) effort to engage experts in the field to: (1) identify current barriers to optimal care; (2) highlight compelling scientific evidence that would justify changes from current policies incorporating best evidence and practice; and (3) propose suggestions that would form the basis for a revised NCD in each of these 5 areas (thoracic restrictive disorders, COPD, hypoventilation syndromes, OSA, and central sleep apnea). The expert panel met during a 2-day virtual summit in October 2020 and subsequently crafted written documents designed to achieve provision of "the right device to the right patient at the right time." These documents have been endorsed by the participating societies following peer review and publication in CHEST and will be used to inform efforts to revise the current NCDs.

Randomized Controlled Trial of a Novel Communication Device Assessed During Noninvasive Ventilation Therapy.

BACKGROUND: Noninvasive ventilation (NIV), a form of positive airway pressure (PAP) therapy, is the standard of care for various forms of acute respiratory failure (ARF). Communication impairment is a side effect of NIV, impedes patient care, contributes to distress and intolerance, and potentially increases intubation rates. This study aimed to evaluate communication impairment during CPAP therapy and demonstrate communication device improvement with a standardized protocol. RESEARCH QUESTION: How does an oronasal mask affect communication intelligibility? How does use of an NIV communication device change this communication intelligibility? STUDY DESIGN AND METHODS: A single-center randomized controlled trial (36 outpatients with OSA on CPAP therapy) assessed exposure to CPAP 10 cm H2O and PAP communication devices (SPEAX, Ataia Medical). Communication impairment was evaluated by reading selected words and sentences for partners to record and were tabulated as %words correct. Each outpatient-partner pair performed three assessments: (1) baseline (conversing normally), (2) mask baseline (conversing with PAP), and (3) randomized to functioning device (conversing with PAP and device) or sham device. After each stage, both outpatients and partners completed Likert surveys regarding perceived intelligibility and comfort. RESULTS: While conversing with PAP, word and sentence intelligibility decreased relatively by 52% (87% vs 41%) and relatively by 57% (94% vs 40%), respectively, compared with normal conversation. Word and sentence intelligibility in the intervention arm increased relatively by 75% (35% vs 61%; P < .001) and by 126% (33% vs 76%; P < .001) higher than the control arm, respectively. The device improved outpatient-perceived PAP comfort relatively by 233% (15% vs 50%, P = .042) and partner-perceived comfort by relatively 245% (20% vs 69%, P = .0074). INTERPRETATION: Use of this PAP communication device significantly improves both intelligibility and comfort. This is one of the first studies quantifying communication impairment during PAP delivery. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT03795753; URL: www.clinicaltrials.gov.

Consequences and Solutions for the Impact of Communication Impairment on Noninvasive Ventilation Therapy for Acute Respiratory Failure: A Focused Review.

OBJECTIVES: With over 2 million cases of acute respiratory failure in the United States per year, noninvasive ventilation has become a leading treatment modality, often supplanting invasive mechanical ventilation as the initial treatment of choice. Most acute respiratory failure patients use a full face (oronasal) mask with noninvasive ventilation, which is known to impair communication, but its popularity and benefit has led many providers to accept the communication impairment. Medical staff periodically remove masks to communicate with patients, but patients are often limited to short utterances and risk lung derecruitment upon removal of positive pressure. These problems can lead to noninvasive ventilation failure, which is often linked to worse outcomes than first initiating invasive mechanical ventilation and can lead to increased hospitalization costs. DATA SOURCES: We searched MEDLINE and Google Scholar for "speech," "communication," "impairment," "failure," "complications," "NIPPV," "NIV," and "noninvasive ventilation." STUDY SELECTION: We included articles with patients in acute respiratory failure. We excluded articles for patients using noninvasive ventilation therapy for obstructive sleep apnea. DATA SYNTHESIS: Communication impairment has been associated with increasing noninvasive ventilation anxiety (odds ratio, 1.25). Of patients using noninvasive ventilation, 48% require early discontinuation, 22% refuse noninvasive ventilation, and 9% are ultimately intubated. Improvements to communication have been shown to reduce fear and anxiety in invasive mechanical ventilation patients. Analogous communication problems exist with effective solutions in other fields, such as fighter pilot masks, that can be easily implemented to enhance noninvasive ventilation patient care, increase adherence to noninvasive ventilation treatment, and improve patient outcomes. CONCLUSIONS: Communication impairment is an underappreciated cause of noninvasive ventilation complications and failure and requires further characterization. Analogous solutions-such as throat microphones and mask-based microphones-that can be easily implemented show potential as cost-effective methods to reduce noninvasive ventilation failure.

To Die, to Sleep - to Sleep, Perchance to Dream Without Hypertension: Dreams of the Visionary Christian Guilleminault Revisited.

CITATION: Javaheri S, Gay PC. To die, to sleep - to sleep, perchance to dream…without hypertension: dreams of the visionary Christian Guilleminault revisited. J Clin Sleep Med. 2019;15(9):1189-1190.

Noninvasive volume-assured pressure support for chronic respiratory failure: a review.

PURPOSE OF REVIEW: Noninvasive ventilation (NIV) is an established treatment for chronic hypercapnic respiratory failure (CRF). Volume-assured pressure support (VAPS) is a mode of NIV that automatically adjusts inspiratory pressure in order to maintain a constant respiratory volume. We aim to discuss the role and application of VAPS in CRF. RECENT FINDINGS: Recently published meta-analyses and reviews fail to demonstrate a significant difference in gas exchange, sleep, or quality-of-life improvement between VAPS and bilevel positive airway pressure (BPAP) in patients with CRF. A recent manuscript suggests that VAPS therapy in chronic obstructive pulmonary disease patients may reduce the number of exacerbations. It has been shown that with a protocol-driven approach BPAP and VAPS can both be successfully titrated during a single split-night polysomnography. SUMMARY: VAPS is as effective as other modes of NIV at improving ventilation and sleep in CRF. The potential advantage is a more consistent ventilatory support through daytime-nighttime variations and progression of disease over time. However, the impact on long-term outcomes, such as survival, has not been studied.

Effects of Adaptive Servoventilation Therapy for Central Sleep Apnea on Health Care Utilization and Mortality: A Population-Based Study.

STUDY OBJECTIVES: Adaptive servoventilation (ASV) is the suggested treatment for many forms of central sleep apnea (CSA). We aimed to evaluate the impact of treating CSA with ASV on health care utilization. METHODS: In this population-based study using the Rochester Epidemiology Project database, we identified patients over a 9-year period who were diagnosed with CSA (n = 1,237), commenced ASV therapy, and had ≥ 1 month of clinical data before and after ASV initiation. The rates of hospitalizations, emergency department visits (EDV), outpatient visits (OPV) and medications prescribed per year (mean ± standard deviation) in the 2 years pre-ASV and post-ASV initiation were compared. RESULTS: We found 309 patients (68.0 ± 14.6 years, 80.3% male, apnea-hypopnea index 41.6 ± 26.5 events/h, 78% with cardiovascular comorbidities, 34% with heart failure) who met inclusion criteria; 65% used ASV ≥ 4 h/night on ≥ 70% nights in their first month. The overall 2-year mortality rate was 9.4% and CSA secondary to cardiac cause was a significant risk factor for mortality (hazard ratio 1.81, 95% CI 1.09-3.01, P = .02). Comparing pre-ASV and post-ASV initiation, there was no change in the rate of hospitalization (0.72 ± 1.63 versus 0.79 ± 1.44, P = .46), EDV (1.19 ± 2.18 versus 1.26 ± 2.08, P = .54), OPV (31.59 ± 112.42 versus 13.60 ± 17.36, P = .22), or number of prescribed medications (6.68 ± 2.0 versus 5.31 ± 5.86, P = .06). No differences in these outcomes emerged after accounting for adherence to ASV, CSA subtype and comorbidities via multiple regression analysis (all P > .05). CONCLUSIONS: Our cohort of patients with CSA was quite ill and the use of ASV was not associated with a change in health care utilization.

Knowledge Gaps in the Perioperative Management of Adults with Obstructive Sleep Apnea and Obesity Hypoventilation Syndrome. An Official American Thoracic Society Workshop Report.

The purpose of this workshop was to identify knowledge gaps in the perioperative management of obstructive sleep apnea (OSA) and obesity hypoventilation syndrome (OHS). A single-day meeting was held at the American Thoracic Society Conference in May, 2016, with representation from many specialties, including anesthesiology, perioperative medicine, sleep, and respiratory medicine. Further research is urgently needed as we look to improve health outcomes for these patients and reduce health care costs. There is currently insufficient evidence to guide screening and optimization of OSA and OHS in the perioperative setting to achieve these objectives. Patients who are at greatest risk of respiratory or cardiac complications related to OSA and OHS are not well defined, and the effectiveness of monitoring and other interventions remains to be determined. Centers involved in sleep research need to develop collaborative networks to allow multicenter studies to address the knowledge gaps identified below.

Respiratory Compromise as a New Paradigm for the Care of Vulnerable Hospitalized Patients.

Acute respiratory compromise describes a deterioration in respiratory function with a high likelihood of rapid progression to respiratory failure and death. Identifying patients at risk for respiratory compromise coupled with monitoring of patients who have developed respiratory compromise might allow earlier interventions to prevent or mitigate further decompensation. The National Association for the Medical Direction of Respiratory Care (NAMDRC) organized a workshop meeting with representation from many national societies to address the unmet needs of respiratory compromise from a clinical practice perspective. Respiratory compromise may arise de novo or may complicate preexisting lung disease. The group identified distinct subsets of respiratory compromise that present similar opportunities for early detection and useful intervention to prevent respiratory failure. The subtypes were characterized by the pathophysiological mechanisms they had in common: impaired control of breathing, impaired airway protection, parenchymal lung disease, increased airway resistance, hydrostatic pulmonary edema, and right-ventricular failure. Classification of acutely ill respiratory patients into one or more of these categories may help in selecting the screening and monitoring strategies that are most appropriate for the patient's particular pathophysiology. Standardized screening and monitoring practices for patients with similar mechanisms of deterioration may enhance the ability to predict respiratory failure early and prevent its occurrence.

Long-Term Mechanical Ventilation.

Although precise numbers are difficult to obtain, the population of patients receiving long-term ventilation has increased over the last 20 years, and includes patients with chronic lung diseases, neuromuscular diseases, spinal cord injury, and children with complex disorders. This article reviews the equipment and logistics involved with ventilation outside of the hospital. Discussed are common locations for long-term ventilation, airway and secretion management, and many of the potential challenges faced by individuals on long-term ventilation.

Advances and New Approaches to Managing Sleep-Disordered Breathing Related to Chronic Pulmonary Disease.

Chronic obstructive pulmonary disease (COPD) is a common disease affecting about 20 million US adults. Sleep-disordered breathing (SDB) problems are frequent and poorly characterized for patients with COPD. Both the well-known success of noninvasive ventilation (NIV) in the acute COPD exacerbation in the hospital setting and that NIV is the cornerstone of chronic therapy for SDBs have urged the attention of the medical community to determine the impact of NIV on chronic COPD management with and without coexisting SDBs. Early observational studies showed decreased long-term survival rates on patients with COPD with concomitant chronic hypercapnia when compared with normocapnic patients.

Perioperative management of patients with obstructive sleep apnea: a survey of Canadian anesthesiologists.

INTRODUCTION: Obstructive sleep apnea (OSA) may increase the incidence of postoperative complications when undiagnosed. The purpose of this study was to evaluate the perspectives of Canadian anesthesiologists regarding the perioperative management of patients with diagnosed or suspected OSA. METHODS: This study was conducted as a survey of Canadian anesthesiologists using a self-administered scenario-based questionnaire. We initially mailed the survey questionnaire and then mailed it again to non-respondents six weeks later. Subsequently, we e-mailed the online version of our survey to active members of the Canadian Anesthesiologists' Society. RESULTS: The response rates were 35% and 26% for the postal and online modes of administration, respectively. About 50% of the respondents relied on clinical suspicion rather than on a systematic screening to identify patients who may have undiagnosed OSA preoperatively. Forty-seven percent of all respondents either did not know of any institutional policy to guide their perioperative management of patients with OSA or reported an absence of an institutional policy. Fifteen percent of the respondents would discharge diagnosed OSA inpatients with compliant use of continuous positive airway pressure (CPAP) to the ward without monitoring. Nevertheless, a more conservative approach was observed for CPAP non-compliant inpatients. We indeed observed that more than 40% of respondents would send an ambulatory OSA patient home, while another 60% would favour hospital admission. CONCLUSIONS: The majority of anesthesiologists continue to rely on clinical suspicion alone to identify OSA. Moreover, the lack of institutional policy is concerning. A concerted effort to develop an evidence-based guideline may be the next step to assist institutions.