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Continuous positive airway pressure (CPAP) and mandibular advancement device (MAD) therapy are commonly used to treat obstructive sleep apnea (OSA). Differences in efficacy and compliance of these treatments are likely to influence improvements in health outcomes. To compare health effects after 1 month of optimal CPAP and MAD therapy in OSA. In this randomized crossover trial, we compared the effects of 1 month each of CPAP and MAD treatment on cardiovascular and neurobehavioral outcomes. Cardiovascular (24-h blood pressure, arterial stiffness), neurobehavioral (subjective sleepiness, driving simulator performance), and quality of life (Functional Outcomes of Sleep Questionnaire, Short Form-36) were compared between treatments. Our primary outcome was 24-hour mean arterial pressure. A total of 126 patients with moderate-severe OSA (apnea hypopnea index [AHI], 25.6 [SD 12.3]) were randomly assigned to a treatment order and 108 completed the trial with both devices. CPAP was more efficacious than MAD in reducing AHI (CPAP AHI, 4.5 ± 6.6/h; MAD AHI, 11.1 ± 12.1/h; P < 0.01) but reported compliance was higher on MAD (MAD, 6.50 ± 1.3 h per night vs. CPAP, 5.20 ± 2 h per night; P < 0.00001). The 24-hour mean arterial pressure was not inferior on treatment with MAD compared with CPAP (CPAP-MAD difference, 0.2 mm Hg [95% confidence interval, -0.7 to 1.1]); however, overall, neither treatment improved blood pressure. In contrast, sleepiness, driving simulator performance, and disease-specific quality of life improved on both treatments by similar amounts, although MAD was superior to CPAP for improving four general quality-of-life domains. Important health outcomes were similar after 1 month of optimal MAD and CPAP treatment in patients with moderate-severe OSA. The results may be explained by greater efficacy of CPAP being offset by inferior compliance relative to MAD, resulting in similar effectiveness. Clinical trial registered with https://www.anzctr.org.au (ACTRN 12607000289415).

Purpose Nasal continuous positive airway pressure (nCPAP) is currently the gold standard for respiratory support for moderate to severe acute viral bronchiolitis (AVB). Although oxygen delivery via high flow nasal cannula (HFNC) is increasingly used, evidence of its efficacy and safety is lacking in infants. Methods A randomized controlled trial was performed in five pediatric intensive care units (PICUs) to compare 7 cmH 2 O nCPAP with 2 L/kg/min oxygen therapy administered with HFNC in infants up to 6 months old with moderate to severe AVB. The primary endpoint was the percentage of failure within 24 h of randomization using prespecified criteria. To satisfy noninferiority, the failure rate of HFNC had to lie within 15% of the failure rate of nCPAP. Secondary outcomes included success rate after crossover, intubation rate, length of stay, and serious adverse events. Results From November 2014 to March 2015, 142 infants were included and equally distributed into groups. The risk difference of −19% (95% CI −35 to −3%) did not allow the conclusion of HFNC noninferiority ( p  = 0.707). Superiority analysis suggested a relative risk of success 1.63 (95% CI 1.02–2.63) higher with nCPAP. The success rate with the alternative respiratory support, intubation rate, durations of noninvasive and invasive ventilation, skin lesions, and length of PICU stay were comparable between groups. No patient had air leak syndrome or died. Conclusion In young infants with moderate to severe AVB, initial management with HFNC did not have a failure rate similar to that of nCPAP. This clinical trial was recorded in the National Library of Medicine registry (NCT 02457013).

Background High flow nasal cannula therapy (HFNC) and continuous positive airway pressure (CPAP) are two widely used modes of non-invasive respiratory support in paediatric critical care units. The FIRST-ABC randomised controlled trials (RCTs) evaluated the clinical and cost-effectiveness of HFNC compared with CPAP in two distinct critical care populations: acutely ill children (‘step-up’ RCT) and extubated children (‘step-down’ RCT). Clinical effectiveness findings (time to liberation from all forms of respiratory support) showed that HFNC was non-inferior to CPAP in the step-up RCT, but failed to meet non-inferiority criteria in the step-down RCT. This study evaluates the cost-effectiveness of HFNC versus CPAP. Methods All-cause mortality, health-related Quality of Life (HrQoL), and costs up to six months were reported using FIRST-ABC RCTs data. HrQoL was measured with the age-appropriate Paediatric Quality of Life Generic Core Scales questionnaire and mapped onto the Child Health Utility 9D index score at six months. Quality-Adjusted Life Years (QALYs) were estimated by combining HrQoL with mortality. Costs at six months were calculated by measuring and valuing healthcare resources used in paediatric critical care units, general medical wards and wider health service. The cost-effectiveness analysis used regression methods to report the cost-effectiveness of HFNC versus CPAP at six months and summarised the uncertainties around the incremental cost-effectiveness results. Results In both RCTs, the incremental QALYs at six months were similar between the randomised groups. The estimated incremental cost at six months was − £4565 (95% CI − £11,499 to £2368) and − £5702 (95% CI − £11,328 to − £75) for step-down and step-up RCT, respectively. The incremental net benefits of HFNC versus CPAP in step-down RCT and step-up RCT were £4388 (95% CI − £2551 to £11,327) and £5628 (95% CI − £8 to £11,264) respectively. The cost-effectiveness results were surrounded by considerable uncertainties. The results were similar across most pre-specified subgroups, and the base case results were robust to alternative assumptions. Conclusions HFNC compared to CPAP as non-invasive respiratory support for critically-ill children in paediatric critical care units reduces mean costs and is relatively cost-effective overall and for key subgroups, although there is considerable statistical uncertainty surrounding this result.

With increasing use of nCPAP, the safety and comfort associated with nCPAP have come into the forefront. The reported incidence of nasal injuries associated with the use of nCPAP is 20% to 60%. A recent meta-analysis concluded that the use of nasal masks significantly decreases CPAP failure and the incidence of moderate to severe nasal injury and stress the need for a well powered RCT to confirm their findings. In this Open label, 3 arms, sequential, stratified randomized controlled trial, we evaluated the incidence and severity of nasal injury at removal of nCPAP when using two different nasal interfaces and in three groups (i.e. rotation group, mask continue group, prong continue group). Preterm infants with gestation ≤ 30 weeks and respiratory distress within the first 6 hours of birth and in need of CPAP were eligible for the study. Among the 175 newborns included in the study, incidence of nasal injury in mask continue group [n = 19/57 (33.3%)] was significantly less as compared to prong continue group [n = 55/60 (91.6%)] and rotation group [33/ 58 (56.9%), p value <0.0001]. Median maximum nasal injury score was significantly less in Mask continue group as compared to Prong continue group and Rotation group [Injury Score 0 (IQR 0-1) vs. Injury Score 3 (IQR 2-5) vs. Injury Score 1 (IQR 0-2), p value = <0.0001] respectively. The proportion of infants failing nCPAP was similar across the three groups. nCPAP with nasal masks significantly reduces nasal injury in comparison with nasal prongs or rotation of nasal prongs and nasal masks. However, the type of interface did not affect the nCPAP failure rates.

Purpose Experimental animal models of acute respiratory distress syndrome (ARDS) have shown that the updated airway pressure release ventilation (APRV) methodologies may significantly improve oxygenation, maximize lung recruitment, and attenuate lung injury, without circulatory depression. This led us to hypothesize that early application of APRV in patients with ARDS would allow pulmonary function to recover faster and would reduce the duration of mechanical ventilation as compared with low tidal volume lung protective ventilation (LTV). Methods A total of 138 patients with ARDS who received mechanical ventilation for <48 h between May 2015 to October 2016 while in the critical care medicine unit (ICU) of the West China Hospital of Sichuan University were enrolled in the study. Patients were randomly assigned to receive APRV ( n  = 71) or LTV ( n  = 67). The settings for APRV were: high airway pressure (P high ) set at the last plateau airway pressure (P plat ), not to exceed 30 cmH 2 O) and low airway pressure ( P low ) set at 5 cmH 2 O; the release phase (T low ) setting adjusted to terminate the peak expiratory flow rate to ≥ 50%; release frequency of 10–14 cycles/min. The settings for LTV were: target tidal volume of 6 mL/kg of predicted body weight; P plat not exceeding 30 cmH 2 O; positive end-expiratory pressure (PEEP) guided by the PEEP–FiO 2 table according to the ARDSnet protocol. The primary outcome was the number of days without mechanical ventilation from enrollment to day 28. The secondary endpoints included oxygenation, P plat , respiratory system compliance, and patient outcomes. Results Compared with the LTV group, patients in the APRV group had a higher median number of ventilator-free days {19 [interquartile range (IQR) 8–22] vs. 2 (IQR 0–15); P  < 0.001}. This finding was independent of the coexisting differences in chronic disease. The APRV group had a shorter stay in the ICU ( P  = 0.003). The ICU mortality rate was 19.7% in the APRV group versus 34.3% in the LTV group ( P  = 0.053) and was associated with better oxygenation and respiratory system compliance, lower P plat , and less sedation requirement during the first week following enrollment ( P  < 0.05, repeated-measures analysis of variance). Conclusions Compared with LTV, early application of APRV in patients with ARDS improved oxygenation and respiratory system compliance, decreased P plat and reduced the duration of both mechanical ventilation and ICU stay.

Underinflation of the tracheal cuff frequently occurs in critically ill patients and represents a risk factor for microaspiration of contaminated oropharyngeal secretions and gastric contents that plays a major role in the pathogenesis of ventilator-associated pneumonia (VAP). To determine the impact of continuous control of tracheal cuff pressure (P(cuff)) on microaspiration of gastric contents. Prospective randomized controlled trial performed in a single medical intensive care unit. A total of 122 patients expected to receive mechanical ventilation for at least 48 hours through a tracheal tube were randomized to receive continuous control of P(cuff) using a pneumatic device (intervention group, n = 61) or routine care of P(cuff) (control group, n = 61). The primary outcome was microaspiration of gastric contents as defined by the presence of pepsin at a significant level in tracheal secretions collected during the 48 hours after randomization. Secondary outcomes included incidence of VAP, tracheobronchial bacterial concentration, and tracheal ischemic lesions. The pneumatic device was efficient in controlling P(cuff). Pepsin was measured in 1,205 tracheal aspirates. Percentage of patients with abundant microaspiration (18 vs. 46%; P = 0.002; OR [95% confidence interval], 0.25 [0.11-0.59]), bacterial concentration in tracheal aspirates (mean ± SD 1.6 ± 2.4 vs. 3.1 ± 3.7 log(10) cfu/ml, P = 0.014), and VAP rate (9.8 vs. 26.2%; P = 0.032; 0.30 [0.11-0.84]) were significantly lower in the intervention group compared with the control group. However, no significant difference was found in tracheal ischemia score between the two groups. Continuous control of P(cuff) is associated with significantly decreased microaspiration of gastric contents in critically ill patients.

Respiratory failure is a leading cause of neonatal mortality in the developing world. Bubble continuous positive airway pressure (bCPAP) is a safe, effective intervention for infants with respiratory distress and is widely used in developed countries. Because of its high cost, bCPAP is not widely utilized in low-resource settings. We evaluated the performance of a new bCPAP system to treat severe respiratory distress in a low resource setting, comparing it to nasal oxygen therapy, the current standard of care. We conducted a non-randomized convenience sample study to test the efficacy of a low-cost bCPAP system treating newborns with severe respiratory distress in the neonatal ward of Queen Elizabeth Central Hospital, in Blantyre, Malawi. Neonates weighing >1,000 g and presenting with severe respiratory distress who fulfilled inclusion criteria received nasal bCPAP if a device was available; if not, they received standard care. Clinical assessments were made during treatment and outcomes compared for the two groups. 87 neonates (62 bCPAP, 25 controls) were recruited. Survival rate for neonates receiving bCPAP was 71.0% (44/62) compared with 44.0% (11/25) for controls. 65.5% (19/29) of very low birth weight neonates receiving bCPAP survived to discharge compared to 15.4% (1/13) of controls. 64.6% (31/48) of neonates with respiratory distress syndrome (RDS) receiving bCPAP survived to discharge, compared to 23.5% (4/17) of controls. 61.5% (16/26) of neonates with sepsis receiving bCPAP survived to discharge, while none of the seven neonates with sepsis in the control group survived. Use of a low-cost bCPAP system to treat neonatal respiratory distress resulted in 27% absolute improvement in survival. The beneficial effect was greater for neonates with very low birth weight, RDS, or sepsis. Implementing appropriate bCPAP devices could reduce neonatal mortality in developing countries.

Poor adherence to continuous positive airway pressure (CPAP) commonly affects therapeutic response in obstructive sleep apnea (OSA). We aimed to determine predictors of adherence to CPAP among participants of the Sleep Apnea and cardioVascular Endpoints (SAVE) trial. SAVE was an international, randomized, open trial of CPAP plus usual care versus usual care (UC) alone in participants (45-75 years) with co-occurring moderate-to-severe OSA (≥12 episodes/h of ≥4% oxygen desaturation) and established cardiovascular (CV) disease. Baseline sociodemographic, health and lifestyle factors, OSA symptoms, and 1-month change in daytime sleepiness, as well as CPAP side effects and adherence (during sham screening, titration week, and in the first month), were entered in univariate linear regression analyses to identify predictors of CPAP adherence at 24 months. Variables with p <0.2 were assessed for inclusion in a multivariate linear mixed model with country, age, and sex included a priori and site as a random effect. Significant univariate predictors of adherence at 24 months in 1,121 participants included: early adherence measures, improvement in daytime sleepiness at 1 month, fixed CPAP pressure, some measures of OSA severity, cardiovascular disease history, breathing pauses, and very loud snoring. While observed adherence varied between countries, adherence during sham screening, initial titration, and the first month of treatment retained independent predictive value in the multivariate model along with fixed CPAP pressure and very loud snoring. Early CPAP adherence had the greatest predictive value for identifying those at highest risk of non-adherence to long-term CPAP therapy. SAVE is registered with clinicaltrials.gov (NCT00738179).

Many people worldwide experience obstructive sleep apnea, which is associated with medical and psychological problems. Continuous positive airway pressure (CPAP) is an efficacious therapy for obstructive sleep apnea, but its effect is limited by nonadherence. Studies show that personalized education and feedback can increase CPAP adherence. Moreover, tailoring the style of information to the psychological profile of a patient has been shown to enhance the impact of interventions. This study aimed to assess the effect of an intervention providing digitally generated personalized education and feedback on CPAP adherence and the additional effect of tailoring the style of the education and feedback to an individual's psychological profile. This study was a 90-day, multicenter, parallel, single-blinded, and randomized controlled trial with 3 conditions: personalized content in a tailored style (PT) in addition to usual care (UC), personalized content in a nontailored style (PN) in addition to UC, and UC. To test the effect of personalized education and feedback, the PN + PT group was compared with the UC group. To test the additional effect of tailoring the style to psychological profiles, the PN and PT groups were compared. Overall, 169 participants were recruited from 6 US sleep clinics. The primary outcome measures were adherence based on minutes of use per night and on nights of use per week. We found a significant positive effect of personalized education and feedback on both primary adherence outcome measures. The difference in the estimated average adherence based on minutes of use per night between the PT + PN and UC groups on day 90 was 81.3 minutes in favor of the PT + PN group (95% CI -134.00 to -29.10; P=.002). The difference in the average adherence based on nights of use per week between the PT + PN and UC groups at week 12 was 0.9 nights per week in favor of the PT + PN group (difference in odds ratio 0.39, 95% CI 0.21-0.72; P=.003). We did not find an additional effect of tailoring the style of the intervention to psychological profiles on the primary outcomes. The difference in nightly use between the PT and PN groups on day 90 (95% CI -28.20 to 96.50; P=.28) and the difference in nights of use per week between the PT and PN groups at week 12 (difference in odds ratio 0.85, 95% CI 0.51-1.43; P=.054) were both nonsignificant. The results show that personalized education and feedback can increase CPAP adherence substantially. Tailoring the style of the intervention to the psychological profiles of patients did not further increase adherence. Future research should investigate how the impact of interventions can be enhanced by catering to differences in psychological profiles. ClinicalTrials.gov NCT02195531; https://clinicaltrials.gov/ct2/show/NCT02195531.

Abstract Study Objectives Insomnia and obstructive sleep apnea (OSA) commonly co-occur which makes OSA difficult to treat with continuous positive airway pressure (CPAP). We conducted a randomized controlled trial in participants with OSA and co-occurring insomnia to test the hypothesis that initial treatment with cognitive and behavioral therapy for insomnia (CBT-i), versus treatment as usual (TAU) would improve insomnia symptoms and increase subsequent acceptance and use of CPAP. Methods One hundred and forty-five participants with OSA (apnea-hypopnea index ≥ 15) and comorbid insomnia were randomized to either four sessions of CBT-i, or TAU, before commencing CPAP therapy until 6 months post-randomization. Primary between-group outcomes included objective average CPAP adherence and changes in objective sleep efficiency by 6 months. Secondary between-group outcomes included rates of immediate CPAP acceptance/rejection, and changes in; sleep parameters, insomnia severity, and daytime impairments by 6 months. Results Compared to TAU, participants in the CBT-i group had 61 min greater average nightly adherence to CPAP (95% confidence interval [CI] = 9 to 113; p = 0.023, d = 0.38) and higher initial CPAP treatment acceptance (99% vs. 89%; p = 0.034). The CBT-i group showed greater improvement of global insomnia severity, and dysfunctional sleep-related cognitions by 6 months (both: p < 0.001), and greater improvement in sleep impairment measures immediately following CBT-i. There were no between-group differences in sleep outcomes, or daytime impairments by 6 months. Conclusions In OSA participants with comorbid insomnia, CBT-i prior to initiating CPAP treatment improves CPAP use and insomnia symptoms compared to commencing CPAP without CBT-i. OSA patients should be evaluated for co-occurring insomnia and considered for CBT-i before commencing CPAP therapy. Clinical Trial Treating comorbid insomnia with obstructive sleep apnea (COMSIA) study: A new treatment strategy for patients with combined insomnia and sleep apnea, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=365184 Australian New Zealand Clinical Trials Registry: ACTRN12613001178730. Universal Trial Number: U1111-1149-4230.