Effectiveness of inspiratory muscle training in difficult to wean patients with neuromuscular diseases: A protocol for a randomized controlled trial

Abstract

Abstract Background: Respiratory failure is the main reason for patients with neuromuscular diseases (NMDs) admitted to the intensive care unit (ICU) for mechanical ventilation. Most of these patients have prolonged ventilation time and difficulty in weaning, resulting in prolonged ICU stay and increased medical costs. Inspiratory muscle training, a treatment method for weaning, has been proven by studies to assist weaning, but few studies have included patients with neuromuscular disease. The aims of this study is to investigate whether inspiratory muscle training can help patients with NMDs who have difficulty weaning from ventilators, and to compare the efficacy of inspiratory muscle strength training and endurance training methods in patients with NMDs. Methods: This is a 4-week, double-blind, prospective randomized controlled study. 150 patients will be recruited and randomly assigned to either inspiratory muscle strength training (IMST) group or inspiratory muscle endurance training (IMET) group, in a 1:1 ratio. Patients, investigators, and outcome assessors are unaware of treatment allocation. The IMST group receives high-intensity training (5 sets of 6 breaths at a minimum of 50% of maximum inspiratory pressure, MIP) once per day, five days per week for four weeks. The IMET group receives low-intensity training (2 sets of 30 breaths at 30% of MIP) once per day, five days per week for four weeks. The primary outcome measure is the weaning success difference between the IMST group and IMET groups. The Secondary outcomes are the duration of weaning process, length of stay in the ICU, duration of mechanical ventilation, MIP, diaphragm mobility, diaphragm thickness, diaphragm thickening fraction and Rapid Shallow Breathing Index. Discussion: The results of the study will provide evidence-based basis for weaning training treatment for patients with neuromuscular diseases and will identify the optimum IMT method for such patients. Trial registration: The study was registered on Chinese Clinical Trial Registry: ChiCTR2300071173 on May 6,2023, https://www.chictr.org.cn/bin/project/edit?pid=195557.