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BackgroundDespite increasing capacity to remotely monitor non-invasive ventilation (NIV), how remote data varies from day to day and person to person is poorly described.MethodsSingle-centre, 2-month, prospective study of clinically stable adults on long-term NIV which aimed to document NIV-device variability. Participants were switched to a ventilator with tele-monitoring capabilities. Ventilation settings and masking were not altered. Raw, extensible markup language data files were provided directly from Philips Respironics (EncoreAnywhere). A nested analysis of variance was conducted on each ventilator variable to apportion the relative variation between and within participants.ResultsTwenty-nine people were recruited (four withdrew, one had insufficient data for analyses; 1364 days of data). Mean age was 54.0 years (SD 18.4), 58.3% male with body mass index of 37.0 kg/m2 (13.7). Mean adherence was 8.53 (2.23) hours/day and all participants had adherence >4 hours/day. Variance in ventilator-derived indices was predominantly driven by differences between participants; usage (61% between vs 39% within), Apnoea–Hypopnoea Index (71% vs 29%), unintentional (64% vs 36%) and total leak (83% vs 17%), tidal volume (93% vs 7%), minute ventilation (92% vs 8%), respiratory rate (92% vs 8%) and percentage of triggered breaths (93% vs 7%).InterpretationIn this clinically stable cohort, all device-derived indices were more varied between users than the day-to-day variation within individuals. We speculate that normative ranges and thresholds for clinical intervention need to be individualised, and further research is necessary to determine the clinically important relationships between clinician targets for therapy and patient-reported outcomes.

A 25‐year‐old male with Duchenne muscular dystrophy and a 73‐year‐old male with motor neurone disease both presented with chest pain and increasing dyspnoea following routine mechanical insufflation‐exsufflation or lung volume recruitment, on a background of long‐term non‐invasive ventilation. In each case, chest radiograph revealed a pneumothorax. In both cases the pneumothorax fully resolved following insertion of an intercostal catheter. There was no immediate recurrence and the patients were discharged home and ceased ongoing prophylactic respiratory therapy, although one person had recurrent pneumothoraces subsequently. This rare but serious complication highlights the need for careful risk/benefit analysis by clinicians prescribing these therapies. A 25‐year‐old male with Duchenne muscular dystrophy and a 73‐year‐old male with motor neurone disease both presented with chest pain and increasing dyspnoea following routine mechanical insufflation‐exsufflation or lung volume recruitment, on a background of long‐term non‐invasive ventilation. In each case, chest radiograph revealed a pneumothorax which resolved with intercostal catheter insertion and cessation of routine lung volume recruitment. This rare but serious complication highlights the need for careful risk/benefit analysis by clinicians prescribing these therapies.

BackgroundObesity hypoventilation syndrome (OHS) is the most common indication for home ventilation, although the optimal therapy remains unclear, particularly for severe disease. We compared Bi-level and continuous positive airways pressure (Bi-level positive airway pressure (PAP); CPAP) for treatment of severe OHS.MethodsWe conducted a multicentre, parallel, double-blind trial for initial treatment of OHS, with participants randomised to nocturnal Bi-level PAP or CPAP for 3 months. The primary outcome was frequency of treatment failure (hospital admission, persistent ventilatory failure or non-adherence); secondary outcomes included health-related quality of life (HRQoL) and sleepiness.ResultsSixty participants were randomised; 57 completed follow-up and were included in analysis (mean age 53 years, body mass index 55 kg/m2, PaCO2 60 mm Hg). There was no difference in treatment failure between groups (Bi-level PAP, 14.8% vs CPAP, 13.3%, p=0.87). Treatment adherence and wake PaCO2 were similar after 3 months (5.3 hours/night Bi-level PAP, 5.0 hours/night CPAP, p=0.62; PaCO2 44.2 and 45.9 mm Hg, respectively, p=0.60). Between-group differences in improvement in sleepiness (Epworth Sleepiness Scale 0.3 (95% CI -2.8, 3.4), p=0.86) and HRQoL (Short Form (SF)36-SF6d 0.025 (95% CI -0.039, 0.088), p=0.45) were not significant. Baseline severity of ventilatory failure (PaCO2) was the only significant predictor of persistent ventilatory failure at 3 months (OR 2.3, p=0.03).ConclusionsIn newly diagnosed severe OHS, Bi-level PAP and CPAP resulted in similar improvements in ventilatory failure, HRQoL and adherence. Baseline PaCO2 predicted persistent ventilatory failure on treatment. Long-term studies are required to determine whether these treatments have different cost-effectiveness or impact on mortality.Trial registration numberACTRN12611000874910, results.

Background Exercise training is recommended for non-cystic fibrosis (CF) bronchiectasis, but the long-term effects are unclear. This randomised controlled trial aimed to determine the effects of exercise training and review of airway clearance therapy (ACT) on exercise capacity, health related quality of life (HRQOL) and the incidence of acute exacerbations in people with non-CF bronchiectasis. Methods Participants were randomly allocated to 8 weeks of supervised exercise training and review of ACT, or control. Primary outcomes of exercise capacity and HRQOL (Chronic respiratory disease questionnaire) and secondary outcomes of cough-related QOL (Leicester cough questionnaire) and psychological symptoms (Hospital anxiety and depression scale) were measured at baseline, following completion of the intervention period and at 6 and 12 months follow up. Secondary outcomes of the exacerbation rate and time to first exacerbation were analysed over 12 months. Results Eighty-five participants (mean FEV 1 74% predicted; median Modified Medical Research Council Dyspnoea grade of 1 (IQR [1–3]) were included. Exercise training increased the incremental shuttle walk distance (mean difference to control 62 m, 95% CI 24 to 101 m) and the 6-minute walking distance (mean difference to control 41 m, 95% CI 19 to 63 m), but these improvements were not sustained at 6 or 12 months. Exercise training reduced dyspnoea (p = 0.009) and fatigue (p = 0.01) but did not impact on cough-related QOL or mood. Exercise training reduced the frequency of acute exacerbations (median 1[IQR 1–3]) compared to the control group (2[1–3]) over 12 months follow up (p = 0.012), with a longer time to first exacerbation with exercise training of 8 months (95% CI 7 to 9 months) compared to the control group (6 months [95% CI 5 to 7 months], p = 0.047). Conclusions Exercise training in bronchiectasis is associated with short term improvement in exercise capacity, dyspnoea and fatigue and fewer exacerbations over 12 months. Trial registry ClinicalTrials.gov ( NCT00885521 ).

Background Non-invasive ventilation (NIV) uses positive pressure to assist people with respiratory muscle weakness or severe respiratory compromise to breathe. Most people use this treatment during sleep when breathing is most susceptible to instability. The benefits of using NIV in motor neurone disease (MND) are well-established. However, uptake and usage are low (~ 19%) and there is no consensus on how to best implement NIV in MND in Australia. Consequently, clinical practice models are highly variable. Our team has recently provided evidence that specific and individualised NIV titration using a sleep study (polysomnography; PSG) leads to better outcomes in people with MND. However, for this clinical practice model to result in sustained benefits, evidence of effectiveness across multiple sites, as well as culture and practice change, must occur. Methods A two-arm, assessor-blinded, individual participant randomised controlled trial in MND care centres across Australia will be undertaken. Two-hundred and forty-four participants will be randomised (1:1) to either the intervention group (PSG-assisted commencement of NIV settings; PSG) or a control group (sham PSG). Participants will be asked to use their NIV device for 7 weeks and will then return for follow-up assessments. Respiratory, sleep and patient-reported outcome measures will be collected at baseline and follow-up. The primary aim is to determine if the proportion of participants using NIV for > 4 h/day during the intervention period is higher in the PSG than the control group. A process evaluation, health economic evaluation and 12-month cohort follow-up will be undertaken and reported separately. Discussion The results of this trial will demonstrate the effects of PSG-assisted titration of NIV on usage of NIV in people with MND. We hypothesise that the PSG intervention will improve synchrony between the user and the machine, which will lead to greater NIV usage compared to the control group. Trial registration ClinicalTrials.gov NCT05136222. Registered on November 25, 2021.

Background We are undertaking a multicentre randomised controlled trial to determine the effectiveness of including a sleep study (polysomnography (PSG)) to assist the commencement of non-invasive ventilation (NIV) in people with motor neurone disease (MND): the Polysomnographic titration of non-invasive ventilation in motor neurone disease (PSG4NIVinMND; 3-three letter acronym ; 3TLA ) trial. A process evaluation will be conducted alongside the clinical trial to understand: (1) the implementation of the 3TLA intervention in the trial sites, including barriers and enablers, and (2) the mechanisms through which the 3TLA intervention produces change. This protocol paper describes the rationale, aims and methods of the 3TLA process evaluation. Methods To guide the design of the process evaluation, a logic model representing the 3TLA intervention, the likely mechanisms of impact, potential external contextual factors and assumptions, and the anticipated outcomes was developed by the researchers in collaboration with the 3TLA Trial Steering Committee. From this, five key process evaluation research questions were identified, a priori. The mixed-methods design is guided by three implementation frameworks: the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework, the Theoretical Domains Framework (TDF), and the Theoretical Framework of Acceptability (TFA). We will conduct semi-structured interviews with approximately 20–30 clinical trial participants (people with MND) and their carers, and focus groups and surveys with approximately 60 health professionals involved in delivering the intervention at each site. Quantitative process data will also be collected from the main clinical trial. Qualitative and quantitative data will be analysed iteratively throughout the trial, independent of the main trial outcome analyses. Process evaluation findings will be triangulated with the results of the clinical trial. Discussion This process evaluation incorporates a mixed-methods design and is informed by three theoretical frameworks. It will provide insights into how the 3TLA intervention was implemented, for whom and how the 3TLA intervention was (and was not) effective, and what adaptations may be needed to facilitate future implementation into routine clinical practice. Trial registration ClinicalTrials.gov NCT05136222. Registered on November 25, 2021.