A preliminary randomized trial of the mechanical insufflator-exsufflator versus breath-stacking technique in patients with amyotrophic lateral sclerosis

Abstract

A major problem faced by patients with amyotrophic lateral sclerosis (ALS) in respiratory failure is the inability to cough effectively. Forty eligible ALS patients were randomized to the breath-stacking technique using a lung volume recruitment bag (n = 21) or mechanical insufflator-exsufflator MI-E (n = 19) and followed up at three-monthly intervals for at least 12 months or until death. Results showed that there were 13 episodes of chest infection in the breath-stacking group and 19 episodes in the MI-E group (p = 0.92), requiring 90 and 95 days of antibiotics, respectively (p = 0.34). The mean duration of symptoms per chest infection was 6.9 days in the breath-stacking group and 3.9 days in MI-E group (p = 0.16). There were six episodes of hospitalization in each group (p = 0.64). The chance of hospitalization, in the event of a chest infection, was 0.46 in the breath-stacking group and 0.31 in MI-E group (p = 0.47). Median survival in the breath-stacking group was 535 days and 266 days in the MI-E group (p = 0.34). The QoL was maintained above 75% of baseline for a median of 329 days in the breath-stacking group and 205 days in the MI-E group (p = 0.41). In conclusion, lack of statistically significant differences due to sub-optimal power and confounders precludes a definitive conclusion with respect to the relative efficacy of one cough augmentation technique over the other. This study however, provides useful lessons and informative data, needed to strengthen the power calculation, inclusion criteria and randomization factors for a large scale definitive trial. Until such a definitive trial can be undertaken, we recommend the breath-stacking technique as a low-cost, first-line intervention for volume recruitment and cough augmentation in patients with ALS who meet the criteria for intervention with non-invasive ventilation.

Key words::

• Amyotrophic lateral sclerosis
• insufflation
• exsufflation
• mechanical in-exsufflator
• lung volume recruitment
• manual breath-stacking technique
• cough assist
• cough augmentation

Acknowledgements

Respironics, UK Ltd. provided the coughAssist^® devices required for the study. PJS is supported by an NIHR Senior Investigator Award. We are very grateful to the ALS patients and their carers who gave of their time to participate in this study.

This study was sponsored by The Motor Neurone Disease Association and Sheffield Teaching Hospitals NHS Foundation Trust. Funding was provided by the Motor Neurone Disease Association (grant ref: Shaw/Apr08/6335). The study sponsors had no role in trial design, data collection, data analysis, data interpretation, writing of the report, or the decision to submit for publication.

Declaration of interest: The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.

Supplementary material available online

Supplementary Figure 1 and Table 1 to be found online at http://informahealthcare.com/doi/abs/10.3109/21678421.2015.1051992.