Home monitoring of daytime mouthpiece ventilation effectiveness in patients with neuromuscular disease.

Mouthpiece ventilation (MPV) allows patients with neuromuscular disease to receive daytime support from a portable ventilator, which they can disconnect at will, for example, for speaking, eating, swallowing, and coughing. However, MPV carries a risk of underventilation. Our purpose here was to evaluate the effectiveness of daytime MPV under real-life conditions. Eight wheelchair-bound patients who used MPV underwent daytime polygraphy at home with recordings of airflow, mouthpiece pressure, thoracic and abdominal movements, peripheral capillary oxygen saturation (SpO2), and transcutaneous partial pressure of carbon dioxide (PtcCO2). Times and durations of tasks and activities were recorded. The Apnea-Hypopnea Index (AHI) was computed. Patient-ventilator disconnections ≥3 minutes and episodes of hypoventilation defined as PtcCO2>45 mmHg were counted. Patient-ventilator asynchrony events were analyzed. The AHI was >5 hour(-1) in two patients. Another patient experienced unexplained 3% drops in arterial oxygen saturations at a frequency of 70 hour(-1). Patient-ventilator disconnections ≥3 minutes occurred in seven of eight patients and were consistently associated with decreases in SpO2 and ≥5-mmHg increases in PtcCO2; PtcCO2 rose above 45 mmHg in two patients during these disconnections. The most common type of patient-ventilator asynchrony was ineffective effort. This study confirms that MPV can be effective as long as the patient remains connected to the mouthpiece. However, transient arterial oxygen desaturation and hypercapnia due to disconnection from the ventilator may occur, without inducing unpleasant sensations in the patients. Therefore, an external warning system based on a minimal acceptable value of minute ventilation would probably be useful.

Accuracy of tidal volume delivered by home mechanical ventilation during mouthpiece ventilation: A bench evaluation.

The aim of our study was to evaluate efficacy and reliability of currently available ventilators for mouthpiece ventilation (MPV). Five life-support home ventilators were assessed in a bench test using different settings simulating the specificities of MPV, such as intermittent circuit disconnection and presence of continuous leaks. The intermittent disconnection of the circuit caused relevant swings in the delivered tidal volume ( VT), showing a VT overshoot during the disconnection periods and a VT decrease when the interface was reconnected to the test lung. The five ventilators showed substantial differences in the number of respiratory cycles necessary to reach a stable VT in the volume-controlled setting, ranging from 1.3 ± 0.6 to 7.3 ± 1.2 cycles. These differences were less accentuated in the volume-assisted setting (MPV-dedicated mode, when available). Our data show large differences in the capacity of the different ventilators to deal with the rapidly changing respiratory load features that characterize MPV, which can be further accentuated according to the used ventilator setting. The dedicated MPV modes allow improvement in the performance of ventilators only in some defined situations. This has practical consequences for the choice of the ventilator to be used for MPV in a specific patient.

Noninvasive Ventilation Automated Technologies: A Bench Evaluation of Device Responses to Sleep-Related Respiratory Events.

BACKGROUND: Noninvasive ventilation (NIV) is the reference standard treatment for most situations of chronic respiratory failure. NIV settings must be titrated to both preserve upper-airway patency and control hypoventilation. Automatic adjustment of pressure support (PS) and expiratory positive airway pressure (EPAP) may facilitate the initiation and follow-up of domiciliary NIV. However, whether the automatic-adjustment algorithms embedded into current devices accurately detect, respond to, and score common sleep-related respiratory events remains unclear. METHODS: A bench was set up to simulate central hypopnea (CH), central apnea (CA), obstructive hypopnea (OH), and obstructive apnea (OA). Four home ventilators were evaluated, with their dedicated modes for automatic PS and EPAP adjustment. RESULTS: All 4 devices increased PS during CH, CA, and OH. However, PS adjustment varied widely in magnitude, with tidal volumes within 100 ± 20% of the target being provided by only 3 devices for CH, one for CA, and one for OH. Two devices increased EPAP for OH and 3 for OA, including one that also increased EPAP for CA. Only 2 devices scored residual hypopnea after simulated CA, and only one scored a residual event after OH. One device scored no event. CONCLUSIONS: Current NIV devices differed markedly in their responses to, and reporting of, standardized sleep-related respiratory events. Further improvements in embedded NIV algorithms are needed to allow more widespread out-of-laboratory initiation and follow-up of NIV.

Comparison of Four Mechanical Insufflation-Exsufflation Devices: Effect of Simulated Airway Collapse on Cough Peak Flow.

BACKGROUND: Mechanical insufflation-exsufflation (MI-E) devices are used to improve airway clearance in individuals with acute respiratory failure. Some MI-E devices measure cough peak flow (CPF) during MI-E to optimize pressure adjustments. The aim was to compare CPF and effective cough volume (ECV: volume expired/coughed > 3 L/s) measurements between 4 MI-E devices under simulated conditions of stable versus collapsed airway. METHODS: Four MI-E devices were tested on the bench. Each device was connected via a standard circuit to a collapsible tube placed in an airtight chamber that was attached to a lung model with adjustable compliance and resistance. Pressure was measured upstream and downstream the collapsing tube; air flow was measured between the chamber and the lung model. Each device was tested in 2 conditions: collapse condition (0 cm H2O) and no-collapse condition (-70 cm H2O). For each condition, 6 combinations of inspiratory/expiratory pressures were applied. CPF was measured at the "mouth level" by the device built-in flow meter and at the "tracheal level" by a dedicated pneumotachograph. Comparisons were performed with non-parametric tests. RESULTS: CPF values measured at the tracheal level and ECV values differed between devices for each inspiratory/expiratory pressure in the collapse and no-collapse conditions (P < .001). CPF values were significantly lower at the tracheal level in the collapse as compared with the no-collapse condition (P < .001 for each device), whereas they were higher at the mouth level (P < .05) for 3 of the 4 devices. CONCLUSIONS: CPF values differed significantly across MI-E devices, highlighting limitation(s) of using only CPF values to determine cough effectiveness. In simulated of airway collapse, CPF increased at the mouth, whereas it decreased at the tracheal level.

Is snoring intensity responsible for the sleep partner's poor quality of sleep?

PURPOSE: This study aimed to determine if the intensity of breathing noise (including snoring) and/or the presence of abnormal breathing events (ABE) are factors that trigger arousal/awakening of a snorer's bed partner. METHODS: We conducted a prospective multicenter study investigating couples where the male had a chronic disturbing snoring. We simultaneously recorded the male's respiration and snoring and the female' sleep. We counted the number of arousals and awakenings during N2 sleep and randomly took nine of each. Then, for periods before, during, and after each arousal and awakening, we observed on the respiratory tracings what was happening in terms of breathing noise intensity and presence/absence of snoring and/or ABE. RESULTS: Thirteen couples were analyzed. The intensity of breathing noise and the presence/absence of snoring and/or ABE were comparable before and at initiation of arousal/awakening and between arousal and awakening. However, breathing volume intensity was lower and the presence of snoring and/or ABE was less frequent when the bed partner returned back to sleep from awakening compared to the other periods (p always <0.001). CONCLUSIONS: The intensity of breathing noise or the presence of ABE does not seem to be essential to trigger an arousal or an awakening. However, the persistence of noise or events may prolong the duration of wakefulness during the sleep period and could be one factor that explains the bothersome snoring.

Quality versus emergency: How good were ventilation fittings produced by additive manufacturing to address shortages during the COVID19 pandemic?

OBJECTIVE: The coronavirus disease pandemic (COVID-19) increased the risk of shortage in intensive care devices, including fittings with intentional leaks. 3D-printing has been used worldwide to produce missing devices. Here we provide key elements towards better quality control of 3D-printed ventilation fittings in a context of sanitary crisis. MATERIAL AND METHODS: Five 3D-printed designs were assessed for non-intentional (junctional and parietal) and intentional leaks: 4 fittings 3D-printed in-house using FDeposition Modelling (FDM), 1 FDM 3D-printed fitting provided by an independent maker, and 2 fittings 3D-printed in-house using Polyjet technology. Five industrial models were included as controls. Two values of wall thickness and the use of coating were tested for in-house FDM-printed devices. RESULTS: Industrial and Polyjet-printed fittings had no parietal and junctional leaks, and satisfactory intentional leaks. In-house FDM-printed fittings had constant parietal leaks without coating, but this post-treatment method was efficient in controlling parietal sealing, even in devices with thinner walls (0.7 mm vs 2.3 mm). Nevertheless, the use of coating systematically induced absent or insufficient intentional leaks. Junctional leaks were constant with FDM-printed fittings but could be controlled using rubber junctions rather than usual rigid junctions. The properties of Polyjet-printed and FDM-printed fittings were stable over a period of 18 months. CONCLUSIONS: 3D-printing is a valid technology to produce ventilation devices but requires care in the choice of printing methods, raw materials, and post-treatment procedures. Even in a context of sanitary crisis, devices produced outside hospitals should be used only after professional quality control, with precise data available on printing protocols. The mechanical properties of ventilation devices are crucial for efficient ventilation, avoiding rebreathing of CO2, and preventing the dispersion of viral particles that can contaminate health professionals. Specific norms are still required to formalise quality control procedures for ventilation fittings, with the rise of 3D-printing initiatives and the perspective of new pandemics.

Protective Recommendations for Non-invasive Ventilation During COVID-19 Pandemic: A Bench Evaluation of the Effects of Instrumental Dead Space on Alveolar Ventilation.

INTRODUCTION: With the current COVID-19 pandemic, concerns have raised regarding the risk for NIV to promote airborne transmission. In case of hospital admission, continuation of therapy in patients undergoing chronic NIV is necessary and several protective circuit configurations have been recommended to reduce the risk of aerosol dissemination. However, all these configurations increase instrumental dead space. We therefore designed this study to evaluate their effects on the tidal volume (VTE) required to preserve stable end-tidal CO2 partial pressure (PETCO2) with constant respiratory rate. METHODS: A bench consisting of a test lung connected to an adult-sized mannequin head was set up. The model was ventilated through usual domiciliary configuration (single limb circuit with facial vented mask) which was used as reference. Then, five different circuit configurations including non-vented facial mask with viral/bacterial filter, modification of leak position, and change from single to double-limb circuit were evaluated. For each configuration, pressure support (PS) was gradually increased to reach reference PETCO2. Resulting VTE was recorded as primary outcome. RESULTS: Reference PETCO2 was 38(0) mmHg, with a PS set at 10 cmH2O, resulting in a VTE of 432(2) mL. Compared to reference, all the configurations evaluated required substantial increase in VTE to preserve alveolar ventilation, ranging from +79(2) to +216(1) mL. CONCLUSIONS: Modifications of NIV configurations in the context of COVID-19 pandemic result in substantial increase of instrumental dead space. Re-evaluation of treatment efficiency and settings is crucial whenever protective measures influencing NIV equipment are considered.

INTRODUCCIÓN: Durante la actual pandemia de COVID-19 ha surgido la preocupación sobre el posible riesgo de que la ventilación no invasiva (VNI) promueva la transmisión aérea. En el caso de ingreso hospitalario, es necesario continuar con el tratamiento de aquellos pacientes tratados con VNI crónica y se han recomendado varias configuraciones protectoras de los circuitos para reducir el riesgo de diseminación por aerosoles. Sin embargo, todas estas configuraciones aumentan el espacio muerto instrumental. Así, diseñamos este estudio para evaluar los efectos de estas configuraciones sobre el volumen corriente (VCE) necesario para mantener estable la presión parcial de CO2 al final del volumen corriente espirado (PETCO2) con una frecuencia respiratoria constante. MÉTODOS: Se construyó un modelo experimental que constaba de un pulmón de prueba conectado a una cabeza de maniquí de tamaño adulto. El modelo recibió ventilación utilizando la configuración domiciliaria habitual (circuito de rama única con máscara facial ventilada), lo que se utilizó como referencia. Después se evaluaron cinco configuraciones diferentes del circuito, incluidas la máscara facial sin ventilación con filtro antiviral/antibacteriano, la modificación de la posición de la fuga y el cambio de circuito de rama única a doble rama. Para cada configuración, la presión de soporte (PS) se incrementó gradualmente hasta alcanzar la PETCO2 de referencia. El VCE resultante se registró como resultado primario. RESULTADOS: La PETCO2 de referencia fue de 38(0) mmHg, con una PS fijada en 10 cmH2O, lo que resultó en un VCE de 432(2) mL. En comparación con la referencia, todas las configuraciones evaluadas requirieron un aumento sustancial del VCE para preservar la ventilación alveolar, en un rango entre +79(2) mL y +216(1) mL. CONCLUSIONES: Las modificaciones de las configuraciones de VNI en el contexto de la pandemia de COVID-19 resultan en un aumento sustancial del espacio muerto instrumental. Reevaluar la eficacia y los ajustes del tratamiento es fundamental cuando se ponen en consideración unas medidas de protección que influyen en el equipo de VNI.

Impact of Interface Type on Noninvasive Ventilation Efficacy in Patients With Neuromuscular Disease: A Randomized Cross-Over Trial.

BACKGROUND AND OBJECTIVE: Around 25% of patients with neuro-muscular diseases (NMD) are treated by home noninvasive ventilation (NIV) through an oronasal mask. However, there is growing evidence that nasal masks require lower NIV pressures and result in fewer residual obstructive events. We hypothesized that nasal masks would improve efficacy and reduce side effects compared to oronasal masks in this population. METHODS: open label, cross-over, randomized, study in 2 tertiary care hospitals. Patients with NMD treated by home NIV were randomized for one-week periods to nasal and oronasal interfaces respectively (cross-over). At the end of each period, nocturnal polygraphy (monitoring mouth opening) under NIV, synchronized with transcutaneous partial pressure in CO2 (tcCO2) was performed. Data were collected from the NIV built-in software and NIV side-effects were collected. Intention-to-treat and per protocol analyses were performed. The primary outcome was mean nocturnal SpO2. The secondary outcomes were: percentage of sleep with SpO2<90%, oxygen desaturation index (ODI), mean tcCO2, mean duration of mouth opening during sleep, level of non-intentional leaks and side-effects. RESULTS: Thirty patients with NMD were included. There were no between-group differences for either the primary or secondary outcomes. Post hoc comparisons showed that changing between interfaces reduced NIV efficacy: mean nocturnal SpO2 (p=0.04), ODI (p=0.01), mean tcCO2 (p=0.048), side-effects (p=0.008). CONCLUSION: Nasal masks did not improve NIV efficacy or reduce side effects compared to oronasal masks in patients with NMD treated by home NIV. The efficacy of NIV is reduced during the transition to another interface, requiring close monitoring. Registration number: NCT03458507.

Response of Home-Use Adaptive Pressure Modes to Simulated Transient Hypoventilation.

BACKGROUND: Adaptive servoventilation (ASV) is a recently developed ventilation mode designed to stabilize ventilation in patients with central sleep apnea and Cheyne-Stokes respiration. Alternatively, modes aiming to maintain average ventilation over several breaths, such as average volume-assured pressure support (AVAPS) and intelligent volume-assured pressure support (iVAPS), could be efficient during ventilation instability by reducing central events. These modes are available on a variety of devices. This bench evaluation studied the response of these different modes and devices to simulated transient hypoventilation events. METHODS: Three home ventilation devices operating in ASV modes (AirCurve S10 VAuto, ResMed; DreamStation autoSV, Philips; Prisma CR, Löwenstein) and 2 ventilators with the AVAPS mode (DreamStation BiPAP, Philips; Lumis iVAPS, ResMed) were evaluated during transient central hypopnea/hypoventilation simulations characterized by a constant breathing frequency of 15 breaths/min and a progressive decrease of tidal volume (VT) from 500 mL to 50 mL, in 18, 12, 9, and 6 breaths, respectively, followed by a progressive return to the baseline at the same rate. RESULTS: The AirCurve S10 VAuto reacted to a VT decrease between 80% and 50% of baseline VT. DreamStation BiPAP and Prisma CR reacted when VT decreased to between 60% and 30% of baseline VT, whereas the AVAPS response to hypopnea occurred during the crescendo phase of hypopnea/hypoventilation VT. The iVAPS response was between that of the AirCurve S10 VAuto and the other ASV devices. Among the ASV devices, the minimum VT was higher with AirCurve S10 VAuto, followed by the Prisma CR and the DreamStation BiPAP. Minimum VT was not influenced by AVAPS and was improved by iVAPS without outperforming the AirCurve S10 VAuto. Maximum VT was increased by iVAPS, whereas ASV devices did not induce a significant VT overshoot. CONCLUSIONS: ASV devices improved central hypopnea/hypoventilation events without inducing hyperpnea events and therefore were better adapted than AVAPS and iVAPS devices, with notable differences in their responses to hypoventilation events.

Evaluation of the efficacy of a dedicated table to improve CPAP adherence in children: a pilot study.

OBJECTIVE: Only a few studies have addressed strategies to improve continuous positive airway pressure (CPAP) adherence in children with obstructive sleep apnea. The aim of our study was to assess the efficacy of a table based on token economy to improve CPAP adherence. METHODS: A table was proposed to children nonadherent to CPAP (<3 h per night of CPAP use), eight days after CPAP initiation (D8). The child has to fill the table on a daily basis with green (I used my CPAP this night) or red (I did not use my CPAP) tokens. Objectives of CPAP use and rewards were decided between the child and their parents. An assessment of CPAP adherence was performed one month after initiation of table filling (M1) and compared to CPAP adherence at D8, and to data of adherent children. RESULTS: Data of six nonadherent and nine adherent children were gathered (age 5 ± 5 vs. 5 ± 3 years, p = 0.953; apnea-hypopnea index 20 ± 15 vs. 25 ± 16 events/h, p = 0.550, respectively). Mean CPAP adherence at D8 was 4.7 ± 1.6 nights/wk and 1h00 ± 0h33 in the nonadherent children, vs. 6.9 ± 0.4 nights/wk and 7h16 ± 1h51 in the adherent group (p < 0.01). The mean number of nights per week at M1 was 6.4 ± 0.6 nights in nonadherent children (p = 0.086), and was equivalent to that in adherent children (6.8 ± 0.6 nights, p = 0.126). Mean adherence at M1 increased to 4h31 ± 1h12 in non-adherent children (p < 0.001), but was still lower when compared to that in adherent children (7h27 ± 2h00, p = 0.007). CONCLUSION: The study findings imply that use of a simple table by a child appears to be effective in improving CPAP adherence at one month.

Bench evaluation of commercially available and newly developed interfaces for mouthpiece ventilation.

INTRODUCTION: Mouthpiece ventilation represents a valuable treatment for patients needing daytime non-invasive ventilation. This modality is however underused, in part because of limitations in the available equipment. OBJECTIVE: To develop a new flexible and moldable mouthpiece, aiming to address some of the issues of the currently available interfaces. METHODS: We compared two commercially available and the newly developed mouthpieces in a bench test using four life-support home ventilators and three settings per ventilator. RESULTS: The three interfaces showed marked differences in their resistive characteristics. In the volume-controlled setting (VC-CMV) with 500 mL tidal volume (VT ), the delivered VT , ranged between 459 ± 7 mL (-8%) and 501 ± 4 mL (+0.2%), according to the used ventilator. In the VC-CMV setting with VT 1000 mL, one of the ventilators did not assure the set VT with the new mouthpiece, because of the high-pressure limitation. In the pressure-controlled setting (PC-CMV at 20 cmH2 O), the effective pressure differed between the tested interfaces according to their resistance, resulting in a decrease in the delivered VT . CONCLUSIONS: They found measurable differences in the ventilation's performances comparing the interfaces for mouthpiece ventilation, which seem to have a minor clinical relevance in the most settings, but should be systematically checked. They validated in-vitro the newly developed mouthpiece with respect to the ventilation performances; a clinical study is needed to investigate the potential advantages we expect from the new mouthpiece.

Bench evaluation of flow limitation detection by automated continuous positive airway pressure devices.

STUDY OBJECTIVE: Automatic continuous positive airway pressure (CPAP) devices that adjust the pressure delivered to the patient are now available to treat sleep-disordered breathing. Sophisticated auto-CPAP devices can detect and correct flattened inspiratory flow contours (FIFCs) associated with subtle upper airway obstruction. However, evaluations of their performance are made difficult by differences across patients and devices. We performed a bench study of five commercially available auto-CPAP devices using a breath waveform simulator to evaluate sensitivity for detecting flattened inspiratory flow. DESIGN: Five degrees of FIFC were simulated. In addition, normal and abnormal flow contours from patients published in the literature were evaluated. MEASUREMENTS AND RESULTS: One device showed autotriggering leading to CPAP increases, and another device varied the CPAP level independently from the presence of an FIFC. The three remaining devices differed regarding the detection of FIFCs and the means used to increase CPAP. CONCLUSION: Based on the characteristics of each patient, physicians must choose among devices with different thresholds of FIFC detection and different pressure responses to detection. Therefore, physicians need details on the algorithms used in auto-CPAP devices. Manufacturers should supply detailed algorithms.

Improvement of the trigger of a ventilator for non-invasive ventilation in children: bench and clinical study.

BACKGROUND AND AIMS: Even though numerous ventilators are licensed for a use in children, very few have been specifically developed for this age range. Therefore, home ventilators may not be able to adequately synchronize with the child's respiratory effort, and the inspiratory triggers (ITs) of assist modes are not always appropriate for children. The aim of the study was to test the improvement of the IT of a ventilator on a pediatric bench and in pediatric patients. METHODS: A classical IT (ITc) and an improved IT [non-invasive ventilation (NIV) + IT] were tested on a bench with six pediatric profiles and in six young patients (mean age 14.1 ± 2.7 years old) requiring long-term NIV. RESULTS: On the bench, trigger time delays (ΔT) and trigger pressures (ΔP) were reduced with the NIV + IT as compared with the ITc (ΔT: 0.481 ± 0.332 vs 0.079 ± 0.022 s for ITc and NIV + IT, respectively, P = 0.027; ΔP: -1.40 ± 0.70 vs -0.42 ± 0.28 cmH2 O for ITc and NIV + IT, respectively, P = 0.046). The clinical study confirmed the decrease in ΔT (0.267 ± 0.061 vs 0.178 ± 0.074 s for ITc and NIV + IT, respectively, P = 0.024) and ΔP (-0.68 ± 0.26 vs -0.39 ± 0.11 cmH2 O for ITc and NIV + IT, respectively, P = 0.030). CONCLUSIONS: The sensitivity of the IT of a ventilator can be improved for pediatric use. The improvements observed on the bench study were confirmed in pediatric patients.

Impact of Interface Type on Noninvasive Ventilation Efficacy in Patients With Neuromuscular Disease: A Randomized Cross-Over Trial / Impacto del tipo de mascarilla en la eficacia de la ventilación no invasiva en pacientes con enfermedad neuromuscular: un ensayo clínico aleatorizado cruzado

Background and objective: Around 25% of patients with neuro-muscular diseases (NMD) are treated by home noninvasive ventilation (NIV) through an oronasal mask. However, there is growing evidence that nasal masks require lower NIV pressures and result in fewer residual obstructive events. We hypothesized that nasal masks would improve efficacy and reduce side effects compared to oronasal masks in this population.Methods: open label, cross-over, randomized, study in 2 tertiary care hospitals. Patients with NMD treated by home NIV were randomized for one-week periods to nasal and oronasal interfaces respectively (cross-over). At the end of each period, nocturnal polygraphy (monitoring mouth opening) under NIV, synchronized with transcutaneous partial pressure in CO2 (tcCO2) was performed. Data were collected from the NIV built-in software and NIV side-effects were collected. Intention-to-treat and per protocol analyses were performed. The primary outcome was mean nocturnal SpO2. The secondary outcomes were: percentage of sleep with SpO2<90%, oxygen desaturation index (ODI), mean tcCO2, mean duration of mouth opening during sleep, level of non-intentional leaks and side-effects.Results: Thirty patients with NMD were included. There were no between-group differences for either the primary or secondary outcomes. Post hoc comparisons showed that changing between interfaces reduced NIV efficacy: mean nocturnal SpO2 (p=0.04), ODI (p=0.01), mean tcCO2 (p=0.048), side-effects (p=0.008). (AU)

Antecedentes y objetivo: Alrededor del 25% de los pacientes con enfermedades neuromusculares (ENM) son tratados mediante ventilación no invasiva (VNI) a través de una máscara oronasal. Sin embargo, existen crecientes indicios de que las máscaras nasales requieren presiones de VNI más bajas y resultan en menos eventos obstructivos residuales. Nuestra hipótesis fue que las máscaras nasales mejorarían la eficacia y reducirían los efectos secundarios en comparación con las máscaras oronasales en esta población.Métodos: Estudio abierto, cruzado, aleatorizado en 2 hospitales de atención terciaria. Los pacientes con ENM tratados mediante VNI domiciliaria fueron aleatorizados durante períodos de una semana de duración a las mascarillas nasales y oronasales, alternativamente (cruzado). Al final de cada período se realizó una polisomnografía nocturna (con monitorización de la apertura bucal) con VNI, sincronizada con la medición transcutánea de la presión parcial de CO2 (tcCO2). Los datos se recopilaron utilizando el software integrado en la VNI y se recogieron los efectos secundarios de la VNI. Se realizaron análisis por intención de tratar y por protocolo. El criterio de valoración principal fue la SpO2 nocturna media. Los criterios secundarios fueron: porcentaje de sueño con SpO2<90%, índice de desaturación de oxígeno (IDO), tcCO2 media, duración media de la apertura bucal durante el sueño, nivel de fugas no intencionales y efectos secundarios.Resultados: Se incluyeron 30 pacientes con ENM. No hubo diferencias entre los grupos para los resultados primarios o secundarios. Las comparaciones a posteriori mostraron que cambiar mascarillas reducía la eficacia de la VNI: SpO2 nocturna media (p=0,04), IDO (p=0,01), tcCO2 media (p=0,048) y efectos secundarios (p=0,008). (AU)

Efficacy and cost of home-initiated auto-nCPAP versus conventional nCPAP.

STUDY OBJECTIVES: To compare in a multicenter prospective study the efficacy and cost of conventional nasal continuous positive airway pressure (nCPAP) initiated at the sleep laboratory versus auto-nCPAP initiated at home. DESIGN: Patients with severe obstructive sleep apnea syndrome (OSAS) were randomized to treatment with either the REM+ auto device in constant mode at the effective pressure determined by titration at the sleep laboratory (n=17) or the REM+ auto device in automatic mode initiated at the patients home by a nurse (n=18). After 2 months, the efficacy and cost of nCPAP therapy and the time from diagnosis to nCPAP were evaluated. All values are reported as means +/- SD. PATIENTS: Thirty-five subjects with newly diagnosed OSAS (8 women and 27 men, mean age: 54.3 +/- 10.6 years, apnea-hypopnea index (AHI) 58.1 +/- 14.0 h(-1)). INTERVENTIONS: N/A. MEASUREMENTS AND RESULTS: Both treatments were used properly and induced similar decreases in the AHI (7.6 +/- 6.9 vs. 10.4 +/ -12.5 h(-1) for auto-nCPAP and conventional nCPAP, respectively; NS) and Epworth Sleepiness score (from 15.5 +/- 4.7 to 7.5 +/- 3.4 vs. 14.7 +/- 3.9 to 7.6 +/- 3.4 for auto-nCPAP and conventional nCPAP, respectively; NS). With auto-nCPAP initiated at home, the time from diagnosis to final adjustment of nCPAP was shorter (16.3 +/- 5.0 vs. 47.2 +/- 46.5 days with conventional nCPAP, P < 0.02) and the cost was lower (1,263 +/- 352 vs. 1720+/-455 E, respectively; P < 0.05). CONCLUSIONS: Treatment of OSAS with auto-nCPAP initiated at home is effective and reliable and reduces the time from diagnosis to therapy and the cost of treatment.

The effect of back-up rate during non-invasive ventilation in young patients with cystic fibrosis.

OBJECTIVE: The aim of the study was to evaluate the effect of the back-up rate on respiratory effort during non-invasive mechanical ventilation. DESIGN: An in vitro study evaluated the inspiratory trigger in seven domiciliary ventilators. Then, a prospective, randomized, crossover trial compared the effect on respiratory effort of three different back-up rates during pressure support (PS) and assist-control/volume-targeted (AC/VT) ventilation. SETTING: A research unit and a tertiary referral pediatric center. PATIENTS: Ten patients with cystic fibrosis (CF). INTERVENTIONS: During the in vivo study, the back-up rate was progressively increased to the maximum that patients could tolerate (Fmax) and respiratory effort, as judged by pressure/time product of the diaphragm (PTPdi/min), was compared between the two ventilatory modes. RESULTS: Differences were observed between trigger pressure, trigger time delay, trigger pressure/time product and the slope between flow and pressure in the seven ventilators. PS and AC/VT ventilation were associated with a decrease in respiratory effort (PTPdi/min was 518+/-172, 271+/-119 and 291+/-138 cmH(2)O. s(-1). min(-1), for spontaneous breathing, PS and AC/VT ventilation, respectively, p=0.05). During the two modes, increasing the back-up rate to Fmax resulted in a greater reduction in PTPdi/min (p=0.001), which was more pronounced during AC/VT ventilation, due to the automatic adjustment of the inspiratory/expiratory time ratio. CONCLUSIONS: Increasing the back-up rate during PS and AC/VT ventilation decreases respiratory effort in young patients with CF, but this effect was more marked with AC/VT ventilation.

Battery life of portable home ventilators: effects of ventilator settings.

BACKGROUND: The battery life (BL) of portable home ventilator batteries is reported by manufacturers. The aim of this study was to evaluate the effects of ventilator mode, breathing frequency, PEEP, and leaks on the BL of 5 commercially available portable ventilators. METHODS: The effects of the ventilator mode (volume controlled-continuous mandatory ventilation [VC-CMV] vs pressure support ventilation [PSV]), PEEP 5 cm H2O, breathing frequency (10, 15, and 20 breaths/min), and leaks during both volume-targeted ventilation and PSV on the BL of 5 ventilators (Elisée 150, Monnal T50, PB560, Vivo 50, and Trilogy 100) were evaluated. Each ventilator was ventilated with a test lung at a tidal volume of 700 ml and an inspiratory time of 1.2 s in the absence of leaks. RESULTS: Switching from PSV to VC-CMV or the addition of PEEP did not significantly change ventilator BL. The increase in breathing frequency from 10 to 20 breaths/min decreased the BL by 18 ± 11% (P = .005). Leaks were associated with an increase in BL during the VC-CMV mode (18 ± 20%, P = .04) but a decrease in BL during the PSV mode (-13 ± 15%, P = .04). CONCLUSIONS: The BL of home ventilators depends on the ventilator settings. BL is not affected by the ventilator mode (VC-CMV or PSV) or the addition of PEEP. BL decreases with an increase in breathing frequency and during leaks with a PSV mode, whereas leaks increase the duration of ventilator BL during VC-CMV.

Evaluation of ventilators for mouthpiece ventilation in neuromuscular disease.

BACKGROUND: Daytime mouthpiece ventilation is a useful adjunct to nocturnal noninvasive ventilation (NIV) in patients with neuromuscular disease. The aims of the study were to analyze the practice of mouthpiece ventilation and to evaluate the performance of ventilators for mouthpiece ventilation. METHODS: Practice of mouthpiece ventilation was assessed by a questionnaire, and the performance of 6 home ventilators with mouthpiece ventilation was assessed in a bench test using 24 different conditions per ventilator: 3 mouthpieces, a child and an adult patient profile, and 4 ventilatory modes. RESULTS: Questionnaires were obtained from 30 subjects (mean age 33 ± 11 y) using NIV for 12 ± 7 y. Fifteen subjects used NIV for > 20 h/day, and 11 were totally ventilator-dependent. The subject-reported benefits of mouthpiece ventilation were a reduction in dyspnea (73%) and fatigue (93%) and an improvement in speech (43%) and eating (27%). The bench study showed that none of the ventilators, even those with mouthpiece ventilation software, were able to deliver mouthpiece ventilation without alarms and/or autotriggering in each condition. Alarms and/or ineffective triggering or autotriggering were observed in 135 of the 198 conditions. The occurrence of alarms was more common with a large mouthpiece without a filter compared to a small mouthpiece with a filter (P < .001), but it was not related to the patient profile, the ventilatory mode, or the type of ventilator. CONCLUSIONS: Subjects are satisfied with mouthpiece ventilation. Alarms are common with home ventilators, although less common in those with mouthpiece ventilation software. Improvements in home ventilators are needed to facilitate the expansion of mouthpiece ventilation.

Long-term mechanical ventilation equipment for neuromuscular patients: meeting the expectations of patients and prescribers.

BACKGROUND: To maximize the likelihood of successful long-term mechanical ventilation (MV) in patients with neuromuscular diseases, ventilator characteristics and settings must be chosen carefully, taking into account both medical requisites and the patient's preference and comfort. OBJECTIVES: To evaluate patients' knowledge about and comfort with their long-term MV; to compare patients' and prescribers' opinions and expectations regarding long-term MV; and to compare the equipment used by the patients to the prescribers' current MV prescription. METHODS: Neuromuscular patients receiving long-term MV, and home MV prescribers in Belgium and France were asked to respond to a questionnaire survey specifically developed for the study. RESULTS: Completed questionnaires were collected from 209 patients (mean age 35.4 ± 15.9 y, range 3-86 y), ventilated since 11 ± 17 year, and 45 MV prescribers. One hundred sixty-three (78%) patients correctly designated their MV mode as a volume or pressure controlled mode. When an inspiratory trigger was available, 92% of the patients were able to use it, but only 69% were satisfied. Prescribers were more prone than patients to use new technologies such as an emergency-release system for the noninvasive interface (1-10 visual analog scale score 9.2 ± 1.5 vs 6.8 ± 3.3, P < .001), a humidification system (8.6 ± 1.4 vs 7.8 ± 2.6, P = .02), a contactor for providing larger inspiratory volumes (8.4 ± 1.7 vs 6.0 ± 3.0, P = .009), a built-in cough assistance mode (9.2 ± 1.4 vs 5.5 ± 3.5, P < .001), new options to improve speech, or new MV modes such as a volume-targeted pressure control. CONCLUSIONS: The opinions of patients and prescribers differed about the ideal home ventilator. Patients were less prone to use new technologies, mainly because of a lack of information, underlining the need for regular MV update in patients receiving long-term MV.

Patient-controlled positive end-expiratory pressure with neuromuscular disease: effect on speech in patients with tracheostomy and mechanical ventilation support.

OBJECTIVE: Communication is a major issue for patients with tracheostomy who are supported by mechanical ventilation. The use of positive end-expiratory pressure (PEEP) may restore speech during expiration; however, the optimal PEEP level for speech may vary individually. We aimed to improve speech quality with an individually adjusted PEEP level delivered under the patient's control to ensure optimal respiratory comfort. METHODS: Optimal PEEP level (PEEPeff), defined as the PEEP level that allows complete expiration through the upper airways, was determined for 12 patients with neuromuscular disease who are supported by mechanical ventilation. Speech and respiratory parameters were studied without PEEP, with PEEPeff, and for an intermediate PEEP level. Flow and airway pressure were measured. Microphone speech recordings were subjected to both quantitative and qualitative assessments of speech, including an intelligibility score, a perceptual score, and an evaluation of prosody determined by two speech therapists blinded to PEEP condition. RESULTS: Text reading time, phonation flow, use of the respiratory cycle for phonation, and speech comfort significantly improved with increasing PEEP, whereas qualitative parameters remained unchanged. This resulted mostly from the increase of the expiratory volume through the upper airways available for speech for all patients combined, with a rise in respiratory rate for nine patients. Respiratory comfort remained stable despite high levels of PEEPeff (median, 10.0 cm H2O; interquartile range, 9.5-12.0 cm H2O). CONCLUSIONS: Patient-controlled PEEP allowed for the use of high levels of PEEP with good respiratory tolerance and significant improvement in speech (enabling phonation during the entire respiratory cycle in most patients). The device studied could be implemented in home ventilators to improve speech and, therefore, autonomy of patients with tracheostomy. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT01479959; URL: clinicaltrials.gov.