Effects of mechanical in-exsufflation in preventing postextubation acute respiratory failure in intensive care acquired weakness patients: a randomized controlled trial.

OBJECTIVE: We hypothesized that the use of mechanical insufflation-exsufflation can reduce the incidence of acute respiratory failure within the 48-hour post-extubation period in intensive care unit-acquired weakness patients. METHODS: This was a prospective randomized controlled open-label trial. Patients diagnosed with intensive care unit-acquired weakness were consecutively enrolled based on a Medical Research Council score ≤ 48/60. The patients randomly received two daily sessions; in the control group, conventional chest physiotherapy was performed, while in the intervention group, chest physiotherapy was associated with mechanical insufflation-exsufflation. The incidence of acute respiratory failure within 48 hours of extubation was evaluated. Similarly, the reintubation rate, intensive care unit length of stay, mortality at 28 days, and survival probability at 90 days were assessed. The study was stopped after futility results in the interim analysis. RESULTS: We included 122 consecutive patients (n = 61 per group). There was no significant difference in the incidence of acute respiratory failure between treatments (11.5% control group versus 16.4%, intervention group; p = 0.60), the need for reintubation (3.6% versus 10.7%; p = 0.27), mean length of stay (3 versus 4 days; p = 0.33), mortality at Day 28 (9.8% versus 15.0%; p = 0.42), or survival probability at Day 90 (21.3% versus 28.3%; p = 0.41). CONCLUSION: Mechanical insufflation-exsufflation combined with chest physiotherapy seems to have no impact in preventing postextubation acute respiratory failure in intensive care unit-acquired weakness patients. Similarly, mortality and survival probability were similar in both groups. Nevertheless, given the early termination of the trial, further clinical investigation is strongly recommended. CLINICAL TRIALS REGISTER: NCT01931228.

Effects of mechanical in-exsufflation in preventing postextubation acute respiratory failure in intensive care acquired weakness patients: a randomized controlled trial / Efeitos da insuflação-exsuflação mecânica na prevenção da insuficiência respiratória aguda pós-extubação em pacientes com fraqueza adquirida em terapia intensiva: um estudo controlado e randomizado

ABSTRACT Objective: We hypothesized that the use of mechanical insufflation-exsufflation can reduce the incidence of acute respiratory failure within the 48-hour post-extubation period in intensive care unit-acquired weakness patients. Methods: This was a prospective randomized controlled open-label trial. Patients diagnosed with intensive care unit-acquired weakness were consecutively enrolled based on a Medical Research Council score ≤ 48/60. The patients randomly received two daily sessions; in the control group, conventional chest physiotherapy was performed, while in the intervention group, chest physiotherapy was associated with mechanical insufflation-exsufflation. The incidence of acute respiratory failure within 48 hours of extubation was evaluated. Similarly, the reintubation rate, intensive care unit length of stay, mortality at 28 days, and survival probability at 90 days were assessed. The study was stopped after futility results in the interim analysis. Results: We included 122 consecutive patients (n = 61 per group). There was no significant difference in the incidence of acute respiratory failure between treatments (11.5% control group versus 16.4%, intervention group; p = 0.60), the need for reintubation (3.6% versus 10.7%; p = 0.27), mean length of stay (3 versus 4 days; p = 0.33), mortality at Day 28 (9.8% versus 15.0%; p = 0.42), or survival probability at Day 90 (21.3% versus 28.3%; p = 0.41). Conclusion: Mechanical insufflation-exsufflation combined with chest physiotherapy seems to have no impact in preventing postextubation acute respiratory failure in intensive care unit-acquired weakness patients. Similarly, mortality and survival probability were similar in both groups. Nevertheless, given the early termination of the trial, further clinical investigation is strongly recommended. Clinical Trials Register: NCT 01931228

RESUMO Objetivo: Verificar se o uso de insuflação-exsuflação mecânica pode reduzir a incidência da insuficiência respiratória aguda no período de 48 horas pós-extubação em pacientes com fraqueza adquirida em unidades de terapia intensiva. Métodos: Estudo prospectivo, randomizado, controlado e aberto. Os pacientes diagnosticados com fraqueza adquirida em unidade de terapia intensiva foram incluídos consecutivamente, com base em uma pontuação do Medical Research Council ≤ 48/60. Os pacientes receberam aleatoriamente duas sessões diárias; no grupo controle, realizou-se fisioterapia torácica convencional, enquanto no grupo intervenção, combinou-se fisioterapia torácica com insuflação-exsuflação mecânica. Avaliou-se a incidência de insuficiência respiratória aguda dentro de 48 horas após a extubação. Da mesma forma, avaliaram-se a taxa de reintubação, o tempo de permanência na unidade de terapia intensiva, a mortalidade aos 28 dias e a probabilidade de sobrevida aos 90 dias. O estudo foi interrompido após resultados de futilidade na análise intermediária. Resultados: Incluímos 122 pacientes consecutivos (n = 61 por grupo). Não houve diferença significativa na incidência de insuficiência respiratória aguda entre os tratamentos (11,5% no grupo controle versus 16,4% no grupo intervenção; p = 0,60), na necessidade de reintubação (3,6% versus 10,7%; p = 0,27), no tempo médio de internação (3 versus 4 dias; p = 0,33), na mortalidade aos 28 dias (9,8% versus 15,0%; p = 0,42) ou na probabilidade de sobrevida aos 90 dias (21,3% versus 28,3%; p = 0,41). Conclusão: A insuflação-exsuflação mecânica associada à fisioterapia torácica parece não ter impacto na prevenção da insuficiência respiratória aguda pós-extubação em pacientes com fraqueza adquirida na unidade de terapia intensiva. Da mesma forma, a mortalidade e a probabilidade de sobrevida foram semelhantes em ambos os grupos. No entanto, devido ao término precoce do estudo, recomenda-se enfaticamente uma investigação clínica mais aprofundada. Registro Clinical Trials: NCT 01931228

Effects of Mechanical Insufflation-Exsufflation With Different Pressure Settings on Respiratory Mucus Displacement During Invasive Ventilation.

BACKGROUND: Mechanical insufflation-exsufflation (MI-E) has been proposed as a potential strategy to generate high expiratory flows and simulate cough in the critically ill. However, efficacy and safety of MI-E during invasive mechanical ventilation are still to be fully elucidated. This study in intubated and mechanically ventilated pigs aimed to evaluate the effects of 8 combinations of insufflation-exsufflation pressures during MI-E on mucus displacement, respiratory flows, as well as respiratory mechanics and hemodynamics. METHODS: Six healthy Landrace-Large White female pigs were orotracheally intubated, anesthetized, and invasively ventilated for up to 72 h. Eight combinations of insufflation-exsufflation pressures (+40/-40, +40/-50, +40/-60, +40/-70, +50/-40, +50/-50, +50/-60, +50/-70 cm H2O) were applied in a randomized order. The MI-E device was set to automatic mode, medium inspiratory flow, and an inspiratory-expiratory time 3 and 2 s, respectively, with a 1-s pause between cycles. We performed 4 series of 5 insufflation-exsufflation cycles for each combination of pressures. Velocity and direction of movement of a mucus simulant containing radio-opaque markers were assessed through sequential lateral fluoroscopic images of the trachea. We also evaluated respiratory flows, respiratory mechanics, and hemodynamics before, during, and after each combination of pressures. RESULTS: In 3 of the animals, experiments were conducted twice; and for the remaining 3, they were conducted once. In comparison to baseline mucus movement (2.85 ± 2.06 mm/min), all insufflation-exsufflation pressure combinations significantly increased mucus velocity (P = .01). Particularly, +40/-70 cm H2O was the most effective combination, increasing mucus movement velocity by up to 4.8-fold (P < .001). Insufflation pressure of +50 cm H2O resulted in higher peak inspiratory flows (P = .004) and inspiratory transpulmonary pressure (P < .001) than +40 cm H2O. CONCLUSIONS: MI-E appeared to be an efficient strategy to improve mucus displacement during invasive ventilation, particularly when set at +40/-70 cm H2O. No safety concerns were identified although a transient significant increase of transpulmonary pressure was observed.

Effects of Mechanical Insufflation-Exsufflation on Sputum Volume in Mechanically Ventilated Critically Ill Subjects.

BACKGROUND: Mechanical insufflation-exsufflation (MI-E) is a noninvasive technique performed to simulate cough and remove sputum from proximal airways. To date, the effects of MI-E on critically ill patients on invasive mechanical ventilation are not fully elucidated. In this randomized crossover trial, we evaluated the efficacy and safety of MI-E combined to expiratory rib cage compressions (ERCC). METHODS: Twenty-six consecutive subjects who were sedated, intubated, and on mechanical ventilation > 48 h were randomized to perform 2 sessions of ERCC with or without additional MI-E before tracheal suctioning in a 24-h period. The primary outcome was sputum volume following each procedure. Secondary end points included effects on respiratory mechanics, hemodynamics, and safety. RESULTS: In comparison to ERCC alone, median (interquartile range) sputum volume cleared was significantly higher during ERCC+MI-E (0.42 [0-1.39] mL vs 2.29 [1-4.67] mL, P < .001). The mean ± SD respiratory compliance improved in both groups immediately after the treatment, with the greater improvement in the ERCC+MI-E group (54.7 ± 24.1 mL/cm H2O vs 73.7 ± 35.8 mL/cm H2O, P < .001). Differences between the groups were not significant (P = .057). Heart rate increased significantly in both groups immediately after each intervention (P < .05). Additionally, a significant increase in oxygenation was observed from baseline to 1 h post-intervention in the ERCC+MI-E group (P < .05). Finally, several transitory hemodynamic variations occurred during both interventions, but these were nonsignificant and were considered clinically irrelevant. CONCLUSIONS: In mechanically ventilated subjects, MI-E combined with ERCC increased the sputum volume cleared without causing clinically important hemodynamic changes or adverse events. (ClinicalTrials.gov registration: NCT03316079.).

In the spotlight: Early Career Member Awardee 2020, ERS Lung Science Conference 2021, and Sleep and Breathing 2021.

Interview with @EarlyCareerERS Awardee 2020 @burtin_chris, and a preview of #LungScienceConference and #SleepandBreathing 2021 https://bit.ly/3fUXs1M.

Effectiveness of a Home-Based Active Video Game Programme in Young Cystic Fibrosis Patients.

BACKGROUND: Exercise-based rehabilitation is already a part of cystic fibrosis (CF) treatment; however, patient adherence is low. OBJECTIVES: To assess the effectiveness of a home exercise programme using active video games (AVGs) as a training modality for children and adolescents with CF. METHODS: Thirty-nine children with CF were randomised to a control group (CG, n = 20, age 11 ± 6 years; FEV1 86.2 ± 20.5% of predicted) or a training group (AVGG, n = 19, age 13 ± 3 years; FEV1 82.7 ± 21.7% of predicted). The home training protocol consisted of 30- to 60-min sessions, 5 days/week, for 6 weeks using a Nintendo Wii™ platform. Exercise capacity was measured by the 6-min walk test (6MWT) and modified shuttle walk test (MSWT); muscular strength was estimated using the horizontal jump test (HJT), medicine ball throw (MBT), and hand grip strength (right [RHG]; left [LHG]); and quality of life was rated using the Cystic Fibrosis Questionnaire-Revised (CFQ-R). All the children were measured at baseline, after rehabilitation, and at 12 months. RESULTS: For the group × time interaction ANOVAs, the AVGG showed significant between-group differences in exercise capacity: 6MWT farthest walking distance, 38.4 m (p < 0.01); MSWT farthest walking distance, 78.4 m (p < 0.05); and muscular strength: HJT 9.8 cm, MBT 30.8 cm, RHG 7 kg, and LHG 6.5 kg (p < 0.01), before versus after intervention. The CFQ-R reported significantly higher scores on respiratory symptoms after the intervention and favoured the AVGG, and there was an improvement in other domains after 12 months. Adherence to the home exercise programme was 95% during the 6- week intervention period. CONCLUSION: A home-based programme using AVGs can effectively improve exercise capacity, muscular strength and quality of life in the short-term in children and adolescents with CF. The effects of training on muscle performance and quality of life were sustained over 12 months.