Tele-monitoring of ventilator-dependent patients: a European Respiratory Society Statement.

The estimated prevalence of ventilator-dependent individuals in Europe is 6.6 per 100 000 people. The increasing number and costs of these complex patients make present health organisations largely insufficient to face their needs. As a consequence, their burden lays mostly over families. The need to reduce healthcare costs and to increase safety has prompted the development of tele-monitoring for home ventilatory assistance.A European Respiratory Society Task Force produced a literature research based statement on commonly accepted clinical criteria for indications, follow-up, equipment, facilities, legal and economic issues of tele-monitoring of these patients.Many remote health monitoring systems are available, ensuring safety, feasibility, effectiveness, sustainability and flexibility to face different patients' needs. The legal problems associated with tele-monitoring are still controversial. National and European Union (EU) governments should develop guidelines and ethical, legal, regulatory, technical, administrative standards for remote medicine. The economic advantages, if any, of this new approach must be compared to a "gold standard" of home care that is very variable among different European countries and within each European country.Much more research is needed before considering tele-monitoring a real improvement in the management of these patients.

A Bayesian cost-effectiveness analysis of a telemedicine-based strategy for the management of sleep apnoea: a multicentre randomised controlled trial.

BACKGROUND: Compliance with continuous positive airway pressure (CPAP) therapy is essential in patients with obstructive sleep apnoea (OSA), but adequate control is not always possible. This is clinically important because CPAP can reverse the morbidity and mortality associated with OSA. Telemedicine, with support provided via a web platform and video conferences, could represent a cost-effective alternative to standard care management. AIM: To assess the telemedicine impact on treatment compliance, cost-effectiveness and improvement in quality of life (QoL) when compared with traditional face-to-face follow-up. METHODS: A randomised controlled trial was performed to compare a telemedicine-based CPAP follow-up strategy with standard face-to-face management. Consecutive OSA patients requiring CPAP treatment, with sufficient internet skills and who agreed to participate, were enrolled. They were followed-up at 1, 3 and 6 months and answered surveys about sleep, CPAP side effects and lifestyle. We compared CPAP compliance, cost-effectiveness and QoL between the beginning and the end of the study. A Bayesian cost-effectiveness analysis with non-informative priors was performed. RESULTS: We randomised 139 patients. At 6 months, we found similar levels of CPAP compliance, and improved daytime sleepiness, QoL, side effects and degree of satisfaction in both groups. Despite requiring more visits, the telemedicine group was more cost-effective: costs were lower and differences in effectiveness were not relevant. CONCLUSIONS: A telemedicine-based strategy for the follow-up of CPAP treatment in patients with OSA was as effective as standard hospital-based care in terms of CPAP compliance and symptom improvement, with comparable side effects and satisfaction rates. The telemedicine-based strategy had lower total costs due to savings on transport and less lost productivity (indirect costs). TRIAL REGISTER NUMBER: NCT01716676.

An in vitro study to assess determinant features associated with fluid sealing in the design of endotracheal tube cuffs and exerted tracheal pressures.

OBJECTIVE: To assess the structural characteristics involved in the design of high-volume low-pressure endotracheal tube cuffs that are associated with fluid sealing effectiveness and to determine the extent of transmitted tracheal pressures upon cuff inflation. DESIGN: In vitro study. SETTINGS: Pneumology laboratories. INTERVENTIONS: Eight high-volume low-pressure cuffs of cylindrical or tapered shape, made of polyvinylchloride or polyurethane, were studied. Cuffs were tested within a tracheal model, oriented 30° above horizontal to assess 1 hr leakage of oropharyngeal secretions simulant at cuff internal pressures of 15-30 cm H2O. The four best performing cuffs were evaluated for 24 hrs using an internal pressure of 30 cm H2O. The extent of transmitted tracheal wall pressure throughout the cuff-trachea contact area was determined using an internal pressure sensor within a tracheal model upon cuff inflation up to 30 cm H2O. MEASUREMENTS AND MAIN RESULTS: Outer diameter, length, and compliance of each cuff were assessed. Multivariate regression analysis was performed to identify the main determinants of simulant leakage rate. The cuff-trachea contact area and the percentage of tracheal wall pressure measurements greater than 50 cm H2O were computed. Cuff design characteristics significantly differ among tubes. The cuffs made of polyurethane showed the best short- and long-term sealing efficacy. Nevertheless, in the multivariate analysis, the cuff outer diameter (n: 288, p = 0.003) and length (n: 288, p < 0.001), along with the internal pressure (n: 288, p < 0.001), were the only predictors of simulant leakage rate. The tapered cuffs showed the lowest tracheal wall contact area (n: 96, p < 0.001). The tracheal wall pressure distribution pattern was heterogeneous, and the percentage of high tracheal wall pressure significantly differs among the cuffs (n: 96, p < 0.001). CONCLUSIONS: The high-volume low-pressure cuffs' outer diameter, length, material, and internal pressure are the main determinants of sealing efficacy. Despite internal pressure within the safe range, transmitted tracheal pressure is extremely heterogeneous and differs among cuffs, occasionally reaching localized, very high, unsafe levels.

Cost-effectiveness of a new internet-based monitoring tool for neonatal post-discharge home care.

BACKGROUND: The application of information and communication technologies in nursing care is becoming more widespread, but few applications have been reported in neonatal care. A close monitoring of newborns within the first weeks of life is crucial to evaluating correct feeding, growth, and health status. Conventional hospital-based postdischarge monitoring could be improved in terms of costs and clinical effectiveness by using a telemedicine approach. OBJECTIVE: To evaluate the cost-effectiveness of a new Internet-based system for monitoring low-risk newborns after discharge compared to the standard hospital-based follow-up, with specific attention to prevention of emergency department (ED) visits in the first month of life. METHODS: We performed a retrospective cohort study of two low-risk newborn patient groups. One group, born between January 1, 2011, and June 30, 2011, received the standard hospital-based follow-up visit within 48 hours after discharge. After implementing an Internet-based monitoring system, another group, born between July 19, 2011, and January 19, 2012, received their follow-up with this system. RESULTS: A total of 18 (15.8%) out of 114 newborns who received the standard hospital-based follow-up had an ED visit in the first month of life compared with 5 (5.6%; P=.026) out of 90 infants who were monitored by the Internet-based system. The cost of the hospital-based follow-up was 182.1€ per patient, compared with 86.1€ for the Internet-based follow-up. CONCLUSION: Our Internet-based monitoring approach proved to be both more effective and less costly than the conventional hospital-based follow-up, particularly through reducing subsequent ED visits.

An in-vitro study to evaluate high-volume low-pressure endotracheal tube cuff deflation dynamics.

BACKGROUND: High-volume low-pressure (HVLP) endotracheal tube (ETT) cuffs for critically ill patients often deflate during the course of mechanical ventilation. We performed an in-vitro study to comprehensively assess HVLP cuff deflation dynamics and potential preventive measures. METHODS: We evaluated 24-hour deflation of seven HVLP cuffs of cylindrical or tapered shape, and made of polyvinylchloride or polyurethane. Experiments were performed within a thermostated chamber set at 37 °C. In the first stage of experiments, the cuff pilot balloon valve was not manipulated. The cuff internal pressure was assessed hourly for 24 hours, via a linear position sensor which monitored cuff deflation displacements. Then, we re-evaluated cuff deflation of the worst-performing ETT cuffs with the cuff pilot balloon valve sealed. Finally, we inflated ETT cuffs within an artificial trachea to evaluate deflation dynamics during mechanical ventilation. RESULTS: Initial tests showed an exponential decrease in cuff internal pressure in five out of seven cuffs. Cuffs of cylindrical shape and made of polyurethane demonstrated the fastest deflation rates (P<0.050 vs. cuffs of conical shape and made of polyvinylchloride). When the cuff pilot balloon valve was not sealed, the internal cuff pressure deflation rate differed significantly among ETTs (P=0.005). Yet, upon sealing the cuff pilot balloon valve and during mechanical ventilation, cuff deflation rates decreased (P<0.050). CONCLUSIONS: In controlled in-vitro settings, ETT cuffs consistently deflate over time, and the cuff pilot balloon valve plays a central role in this occurrence. Deflation rate decreases when cuffs are inflated within a plastic artificial tracheal model and mechanical ventilation is activated.

Sleep breathing disorders: have we reached the tipping point?

Sleep medicine: a new approach http://ow.ly/qzVh30iVkWL.

A New mHealth application to support treatment of sleep apnoea patients.

Introduction Continuous positive airway pressure (CPAP) is the first-choice treatment for obstructive sleep apnoea (OSA), but adherence is frequently suboptimal. Innovative, patient-centred interventions are, therefore, needed to enhance compliance. Due to its low cost and ubiquity, mobile health (mHealth) technology seems particularly suited for this purpose. We endeavoured to develop an mHealth application called "APPnea," aimed at promoting patient self-monitoring of CPAP treatment. We then assessed the feasibility and acceptability of APPnea in a group of OSA patients. Methods Consecutive OSA patients used APPnea for six weeks. APPnea gave patients daily reminders to answer three questions about their OSA treatment (CPAP use, physical activity, and diet) and prompted them to upload their body weight weekly. Answers were saved to a secure server for further analysis. After completing the study, patients gave their anonymous opinions about APPnea. Results We enrolled 60 patients with OSA receiving CPAP treatment. The mean age was 56 ± 10 years and the apnoea-hypopnea index was 47 ± 25 events/hour. In total, 63% of participants completed the daily questionnaire for more than 66% of the study period. Objective CPAP compliance was generally high (5.3 ± 1.6 hours/night). In a subset of 38 patients naïve to CPAP, those who used APPnea regularly had significantly higher CPAP compliance. Satisfaction levels were high for the majority of users. Conclusion This mHealth intervention is not only feasible but also satisfactory to patients. Although larger randomized trials and cost-effectiveness studies should be performed, this study shows that APPnea could promote participation and improve compliance among patients with OSA, thereby improving outcomes.

Novel Approach to Simulate Sleep Apnea Patients for Evaluating Positive Pressure Therapy Devices.

Bench testing is a useful method to characterize the response of different automatic positive airway pressure (APAP) devices under well-controlled conditions. However, previous models did not consider the diversity of obstructive sleep apnea (OSA) patients' characteristics and phenotypes. The objective of this proof-of-concept study was to design a new bench test for realistically simulating an OSA patient's night, and to implement a one-night example of a typical female phenotype for comparing responses to several currently-available APAP devices. We developed a novel approach aimed at replicating a typical night of sleep which includes different disturbed breathing events, disease severities, sleep/wake phases, body postures and respiratory artefacts. The simulated female OSA patient example that we implemented included periods of wake, light sleep and deep sleep with positional changes and was connected to ten different APAP devices. Flow and pressure readings were recorded; each device was tested twice. The new approach for simulating female OSA patients effectively combined a wide variety of disturbed breathing patterns to mimic the response of a predefined patient type. There were marked differences in response between devices; only three were able to overcome flow limitation to normalize breathing, and only five devices were associated with a residual apnea-hypopnea index of <5/h. In conclusion, bench tests can be designed to simulate specific patient characteristics, and typical stages of sleep, body position, and wake. Each APAP device behaved differently when exposed to this controlled model of a female OSA patient, and should lead to further understanding of OSA treatment.

Comparative assessment of several automatic CPAP devices' responses: a bench test study.

Automatic continuous positive airway pressure (APAP) devices adjust the delivered pressure based on the breathing patterns of the patient and, accordingly, they may be more suitable for patients who have a variety of pressure demands during sleep based on factors such as body posture, sleep stage or variability between nights. Devices from different manufacturers incorporate distinct algorithms and may therefore respond differently when subjected to the same disturbed breathing pattern. Our objective was to assess the response of several currently available APAP devices in a bench test. A computer-controlled model mimicking the breathing pattern of a patient with obstructive sleep apnoea (OSA) was connected to different APAP devices for 2-h tests during which flow and pressure readings were recorded. Devices tested were AirSense 10 (ResMed), Dreamstar (Sefam), Icon (Fisher & Paykel), Resmart (BMC), Somnobalance (Weinmann), System One (Respironics) and XT-Auto (Apex). Each device was tested twice. The response of each device was considerably different. Whereas some devices were able to normalise breathing, in some cases exceeding the required pressure, other devices did not eliminate disturbed breathing events (mainly prolonged flow limitation). Mean and maximum pressures ranged 7.3-14.6 cmH2O and 10.4-17.9 cmH2O, respectively, and the time to reach maximum pressure varied from 4.4 to 96.0 min. Each APAP device uses a proprietary algorithm and, therefore, the response to a bench simulation of OSA varied significantly. This must be taken into account for nasal pressure treatment of OSA patients and when comparing results from clinical trials.

Telemedicine-based approach for obstructive sleep apnea management: building evidence.

BACKGROUND: Telemedicine seems to offer reliable solutions to health care challenges, but significant contradictory results were recently found. Therefore, it is crucial to carefully select outcomes and target patients who may take advantage of this technology. Continuous positive airway pressure (CPAP) therapy compliance is essential to treat patients with obstructive sleep apnea (OSA). We believe that OSA patients could benefit greatly from a telemedicine approach for CPAP therapy management. OBJECTIVE: The objective of our study was to evaluate the application of a telemedicine-based approach in the CPAP therapy management, focusing on patients' CPAP follow-up and training. METHODS: We performed two studies. First, (study 1) we enrolled 50 consecutive OSA patients who came to our sleep center for the CPAP follow-up visit. Patients performed a teleconsultation with a physician, and once finalized, they were asked to answer anonymously to a questionnaire regarding their opinion about the teleconsultation. In a second randomized controlled trial (RCT) (study 2), we included 40 OSA patients scheduled for CPAP training. There were 20 that received the usual face-to-face training and 20 that received the training via videoconference. After the session, they were blindly evaluated on what they learned about OSA and mask placement. RESULTS: More than 95% (49/50) of the interviewed patients were satisfied with the teleconsultation, and 66% (33/50) of them answered that the teleconsultation could replace 50%-100% of their CPAP follow-up visits. Regarding the RCT, patients who received the CPAP training via videoconference demonstrated the same knowledge about OSA and CPAP therapy as the face-to-face group (mean 93.6% of correct answers vs mean 92.1%; P=.935). Performance on practical skills (mask and headgear placement, leaks avoidance) was also similar between the two groups. CONCLUSIONS: OSA patients gave a positive feedback about the use of teleconsultation for CPAP follow-up, and the CPAP training based on a telemedicine approach proved to be as effective as face-to-face training. These results support the use of this telemedicine-based approach as a valuable strategy for patients' CPAP training and clinical follow-up.

Management of sleep apnea without high pretest probability or with comorbidities by three nights of portable sleep monitoring.

STUDY OBJECTIVES: Obstructive sleep apnea (OSA) diagnosis using simplified methods such as portable sleep monitoring (PM) is only recommended in patients with a high pretest probability. The aim is to determine the diagnostic efficacy, consequent therapeutic decision-making, and costs of OSA diagnosis using polysomnography (PSG) versus three consecutive studies of PM in patients with mild to moderate suspicion of sleep apnea or with comorbidity that can mask OSA symptoms. DESIGN AND SETTING: Randomized, blinded, crossover study of 3 nights of PM (3N-PM) versus PSG. The diagnostic efficacy was evaluated with receiver operating characteristic (ROC) curves. Therapeutic decisions to assess concordance between the two different approaches were performed by sleep physicians and respiratory physicians (staff and residents) using agreement level and kappa coefficient. The costs of each diagnostic strategy were considered. PATIENTS AND RESULTS: Fifty-six patients were selected. Epworth Sleepiness Scale was 10.1 (5.3) points. Bland-Altman plot for apnea-hypopnea index (AHI) showed good agreement. ROC curves showed the best area under the curve in patients with PSG AHI ≥ 5 [0.955 (confidence interval = 0.862-0.993)]. For a PSG AHI ≥ 5, a PM AHI of 5 would effectively exclude and confirm OSA diagnosis. For a PSG AHI ≥ 15, a PM AHI ≥ 22 would confirm and PM AHI < 7 would exclude OSA. The best agreement of therapeutic decisions was achieved by the sleep medicine specialists (81.8%). The best cost-diagnostic efficacy was obtained by the 3N-PM. CONCLUSIONS: Three consecutive nights of portable monitoring at home evaluated by a qualified sleep specialist is useful for the management of patients without high pretest probability of obstructive sleep apnea or with comorbidities. CLINICAL TRIAL REGISTRATION: http://www.clinicaltrials.gov, registration number: NCT01820156. CITATION: Guerrero A, Embid C, Isetta V, Farre R, Duran-Cantolla J, Parra O, Barbé F, Montserrat JM, Masa JF. Management of sleep apnea without high pretest probability or with comorbidities by three nights of portable sleep monitoring.

Electroencephalographic slowing heralds mild cognitive impairment in idiopathic REM sleep behavior disorder.

OBJECTIVE: Patients with idiopathic rapid eye movement (REM) sleep behavior disorder (IRBD) may show electroencephalographic (EEG) slowing reflecting cortical dysfunction and are at risk for developing neurological conditions characterized by cognitive dysfunction including mild cognitive impairment (MCI), dementia with Lewy bodies and Parkinson's disease with associated dementia. We hypothesized that those IRBD patients who later developed MCI had pronounced cortical EEG slowing at presentation. METHODS: Power EEG spectral analysis was blindly quantified from the polysomnographic studies of 23 IRBD patients without cognitive complaints and 10 healthy controls without RBD. After a mean clinical follow-up of 2.40+/-1.55 years, 10 patients developed MCI (RBD+MCI) and the remaining 13 remained idiopathic. RESULTS: Patients with RBD+MCI had marked EEG slowing (increased delta and theta activity) in central and occipital regions during wakefulness and REM sleep, particularly in the right hemisphere, when compared with controls and, to a lesser extent, with IRBD subjects who remained idiopathic. The EEG spectral pattern of the RBD+MCI group was similar to that seen in patients with dementia with Lewy bodies and Parkinson's disease associated with dementia. CONCLUSION: Our findings suggest that the presence of marked EEG slowing on spectral analysis might be indicative of the short-term development of MCI in patients initially diagnosed with IRBD.