A Randomized Controlled Clinical Trial of Lung Volume Recruitment in Adults with Neuromuscular Disease.

Rationale: Clinical care guidelines advise that lung volume recruitment (LVR) be performed routinely by people with neuromuscular disease (NMD) to maintain lung and chest wall flexibility and slow lung function decline. However, the evidence base is limited, and no randomized controlled trials of regular LVR in adults have been published. Objectives: To evaluate the effect of regular LVR on respiratory function and quality of life in adults with NMD. Methods: A randomized controlled trial with assessor blinding was conducted between September 2015 and May 2019. People (>14 years old) with NMD and vital capacity <80% predicted were eligible, stratified by disease subgroup (amyotrophic lateral sclerosis/motor neuron disease or other NMDs), and randomized to 3 months of twice-daily LVR or breathing exercises. The primary outcome was change in maximum insufflation capacity (MIC) from baseline to 3 months, analyzed using a linear mixed model approach. Results: Seventy-six participants (47% woman; median age, 57 [31-68] years; mean baseline vital capacity, 40 ± 18% predicted) were randomized (LVR, n = 37). Seventy-three participants completed the study. There was a statistically significant difference in MIC between groups (linear model interaction effect P = 0.002, observed mean difference, 0.19 [0.00-0.39] L). MIC increased by 0.13 (0.01-0.25) L in the LVR group, predominantly within the first month. No interaction or treatment effects were observed in secondary outcomes of lung volumes, respiratory system compliance, and quality of life. No adverse events were reported. Conclusions: Regular LVR increased MIC in a sample of LVR-naive participants with NMD. We found no direct evidence that regular LVR modifies respiratory mechanics or slows the rate of lung volume decline. The implications of increasing MIC are unclear, and the change in MIC may represent practice. Prospective long-term clinical cohorts with comprehensive follow-up, objective LVR use, and clinically meaningful outcome data are needed. Clinical trial registered with anzctr.org.au (ACTRN12615000565549).

A Multidisciplinary Approach to Verbal Communication Interventions for Mechanically Ventilated Adults With a Tracheostomy.

There is developing evidence with regard to the feasibility, utility, and safety of verbal communication interventions with patients with tracheostomy who are invasively ventilated. In the past 2 decades, research efforts have focused on establishing evidence for communication interventions, including introducing an intentional leak into the ventilatory circuit such as with a fenestrated tube, leak speech or ventilator-adjusted leak speech, the use of a one-way valve in-line with the ventilator, and above cuff vocalization. This narrative review describes the benefits of a multi-disciplinary approach, summarizes verbal communication interventions, and provides guidance on the indications, contraindications and considerations for patient selection. Our clinical procedures based on collective clinical experience are shared. A multidisciplinary team approach enables holistic management across acuity, ventilation, airway, communication, and swallowing parameters. This collaborative approach is recommended to maximize the chance of successful opportunities for patients to communicate safely and effectively.

Silver nitrate therapy for persistent tracheocutaneous fistula following prolonged tracheostomy and invasive ventilation: A case report.

We report the case of a man with severe Guillain-Barré syndrome who developed a persistent tracheocutaneous fistula (TCF) following prolonged tracheostomy and mechanical ventilation. Following tracheostomy decannulation, the TCF had a deleterious effect on non-invasive positive pressure ventilation efficacy and ability to effectively clear airway secretions due to air leaking from the patent stoma. This case highlights a non-surgical approach to TCF management that is not well-described in the literature and presents an alternative management option for cohorts of patients in which the risk associated with surgical interventions may be undesirable.

Measuring Adherence to Long-Term Noninvasive Ventilation.

BACKGROUND: Obtaining benefits from long-term noninvasive ventilation (NIV) relies on achieving adequate adherence to treatment. Reported adherence to NIV is variable and could be influenced by high-volume users and attrition of nonusers and those who die. This observational study aimed to describe patterns of use and adherence rates in new unselected users of NIV. METHODS: All adults (> 18 y old) commencing long-term NIV were consecutively enrolled and followed for 6 months. Ventilator data were manually downloaded from devices and usage (minutes per day) was collected. Subjects were categorized into adherent users (≥ 4 h/d) and nonadherent users (< 4 h/d). RESULTS: Data were obtained from 86 subjects. Most (65%) had motor neuron disease, and most commenced NIV in an out-patient setting (72%). At one month after NIV implementation, overall average daily use was 302.1 min/d and categorical adherence was 57%. At 6 months or prior to death, overall average daily use increased (388.7 min/d), but categorical adherence was similar (62%). The majority of subjects (84%) remained in the same adherence category from their first month to their sixth month of use or death. Individuals with motor neuron disease demonstrated significantly lower rates of adherence compared to the rest of the cohort at 1 month (48% vs 73%, P = .03). In those who died within the study period (n = 19, all with motor neuron disease), this difference persisted to death (42% at death vs 73% at 6 months, P = .032). CONCLUSIONS: Average daily usage may conceal true prevalence of adherence or nonadherence to NIV within a population. Reporting both average daily use data and categorical adherence rates (using a threshold of 4 h/d) may improve transparency of reported outcomes from clinical trials and identifies a therapeutic target for home mechanical ventilation services for quality improvement.

Speech-Language Pathology Guidance for Tracheostomy During the COVID-19 Pandemic: An International Multidisciplinary Perspective.

Purpose As the COVID-19 pandemic has unfolded, there has been growing recognition of risks to frontline health care workers. When caring for patients with tracheostomy, speech-language pathologists have significant exposure to mucosal surfaces, secretions, and aerosols that may harbor the SARS-CoV-2 virus. This tutorial provides guidance on practices for safely performing patient evaluation and procedures, thereby reducing risk of infection. Method Data were collated through review of literature, guidelines, and consensus statements relating to COVID-19 and similar high-consequent infections, with a focus on mitigating risk of transmission to health care workers. Particular emphasis was placed on speech-language pathologists, nurses, and other allied health professionals. A multinational interdisciplinary team then analyzed findings, arriving at recommendations through consensus via electronic communications and video conference. Results Reports of transmission of infection to health care workers in the current COVID-19 pandemic and previous outbreaks substantiate the need for safe practices. Many procedures routinely performed by speech-language pathologists have a significant risk of infection due to aerosol generation. COVID-19 testing can inform level of protective equipment, and meticulous hygiene can stem spread of nosocomial infection. Modifications to standard clinical practice in tracheostomy are often required. Personal protective equipment, including either powered air-purifying respirator or N95 mask, gloves, goggles, and gown, are needed when performing aerosol-generating procedures in patients with known or suspected COVID-19 infection. Conclusions Speech-language pathologists are often called on to assist in the care of patients with tracheostomy and known or suspected COVID-19 infection. Appropriate care of these patients is predicated on maintaining the health and safety of the health care team. Careful adherence to best practices can significantly reduce risk of infectious transmission.

Pneumothorax in neuromuscular disease associated with lung volume recruitment and mechanical insufflation-exsufflation.

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.

Randomised controlled trial of polysomnographic titration of noninvasive ventilation.

Noninvasive ventilation (NIV) settings determined during wakefulness may produce patient-ventilator asynchrony (PVA) during sleep, causing sleep disruption and limiting tolerance. This study investigated whether NIV titrated with polysomnography (PSG) is associated with less PVA and sleep disruption than therapy titrated during daytime alone.Treatment-naive individuals referred for NIV were randomised to control (daytime titration followed by sham polysomnographic titration) or PSG (daytime titration followed by polysomnographic titration) groups. Primary outcomes were PVA and arousal indices on PSG at 10 weeks. Secondary outcomes included adherence, gas exchange, symptoms and health-related quality of life (HRQoL).In total, 60 participants were randomised. Most (88.3%) had a neuromuscular disorder and respiratory muscle weakness but minor derangements in daytime arterial blood gases. PVA events were less frequent in those undergoing polysomnographic titration (median (interquartile range (IQR)): PSG 25.7 (12-68) events·h-1 versus control 41.0 (28-182) events·h-1; p=0.046), but arousals were not significantly different (median (IQR): PSG 11.4 (9-19) arousals·h-1 versus control 14.6 (11-19) arousals·h-1; p=0.258). Overall adherence was not different except in those with poor early adherence (<4 h·day-1) who increased their use after polysomnographic titration (mean difference: PSG 95 (95% CI 29-161) min·day-1 versus control -23 (95% CI -86-39) min·day-1; p=0.01). Arterial carbon dioxide tension, somnolence and sleep quality improved in both groups. There were no differences in nocturnal gas exchange or overall measures of HRQoL.NIV titrated with PSG is associated with less PVA but not less sleep disruption when compared with therapy titrated during daytime alone.

The effect of positive expiratory pressure (PEP) therapy on symptoms, quality of life and incidence of re-exacerbation in patients with acute exacerbations of chronic obstructive pulmonary disease: a multicentre, randomised controlled trial.

BACKGROUND: Positive expiratory pressure (PEP) is a technique used to enhance sputum clearance during acute exacerbations of chronic obstructive pulmonary disease (AECOPD). The impact of PEP therapy during acute exacerbations on clinically important outcomes is not clear. This study sought to determine the effect of PEP therapy on symptoms, quality of life and future exacerbations in patients with AECOPD. METHODS: 90 inpatients (58 men; mean age 68.6 years, FEV(1) 40.8% predicted) with AECOPD and sputum expectoration were randomised to receive usual care (including physical exercise)±PEP therapy. The Breathlessness, Cough and Sputum Scale (BCSS), St George's Respiratory Questionnaire (SGRQ) and BODE index (Body mass index, airflow Obstruction, Dyspnoea, Exercise tolerance) were measured at discharge, 8 weeks and 6 months following discharge, and analysed via linear mixed models. Exacerbations and hospitalisations were recorded using home diaries. RESULTS: There were no significant between-group differences over time for BCSS score [mean (SE) at discharge 5.2 (0.4) vs 5.0 (0.4) for PEP and control group, respectively; p=0.978] or SGRQ total score [41.6 (2.6) vs 40.8 (2.8) at 8 weeks, p=0.872]. Dyspnoea improved more rapidly in the PEP group over the first 8 weeks (p=0.006), however these benefits were not observed at 6 months. Exacerbations (p=0.986) and hospitalisations (p=0.359) did not differ between groups. CONCLUSIONS: We found no evidence that PEP therapy during AECOPD improves important short-term or long-term outcomes. There does not appear to be a routine role for PEP therapy in the management of such individuals.

Safety and feasibility of an exercise intervention for patients following lung resection: a pilot randomized controlled trial.

PURPOSE: Following surgical lung resection, patients frequently suffer functional decline and reduced activity levels. Despite this exercise interventions are not routinely provided. This study aimed to establish the safety and feasibility of exercise administered following lung resection in an Australian setting. METHOD: Pilot randomized controlled trial. Fifteen individuals (53% male), mean ± standard deviation age 65.5 ± 16.1 years, undergoing surgery for suspected lung cancer. Randomization occurred postoperatively. Control arm received protocolized inpatient respiratory physiotherapy. Intervention arm additionally received twice daily exercise until discharge home and twice weekly as outpatient for 8 weeks. Outcome measures (safety, feasibility, functional capacity, functional mobility, and health-related quality of life [HRQoL]) were assessed preoperatively and 2 and 12 weeks postoperatively. RESULTS: Fifteen participants (lung cancer n = 10) were assigned to control (n = 8) and intervention (n = 7) groups. Inpatient exercise was delivered on 71% of occasions (35 out of 49 planned sessions). Four participants attended outpatient exercise sessions and these participants attended sessions on 81% of occasions (52 out of 64 planned sessions). No adverse events occurred. There was a significant between group difference in 6-Minute Walk Test (6MWT; P = .024). In both groups the 6MWT declined from baseline to 2 weeks postoperative and then improved up to 12 weeks; improvements were greater in the intervention group. Intervention was associated with positive trends of improvement in some HRQoL domains. CONCLUSIONS: Exercise intervention performed in the inpatient and outpatient settings for individuals following lung resection was safe and feasible. The uptake rate for outpatient exercise was 57%, similar to previous trials; however, adherence was excellent within the subgroup of participants who attended. Further research is required to investigate the best setting of exercise delivery and explore ways to improve the uptake rate.