Preliminary Effectiveness and Safety of High Frequency Oscillation in Addition to Mechanical Insufflation and Exsufflation for Intratracheal Mucus Removal in Patients With Neuromuscular Disease: Protocol for a Prospective Study

BACKGROUND: Mechanical insufflation-exsufflation (MI-E) is necessary for noninvasive management of respiratory clearance in patients with neuromuscular disorders (NMDs). Its utility has been proven, and the technique is recommended in a number of international guidelines for the management of patients with NMDs. However, the clearance of thick secretions adhering to the tracheobronchial walls could be problematic when these patients suffer from respiratory tract infections. To improve the effectiveness of the noninvasive technique, a novel device combining MI-E with high frequency oscillation (HFO) has been developed. However, the efficacy of HFO therapy in NMDs has not been well studied. OBJECTIVE: The aim of this study was to elucidate the effect of MI-E combined with HFO for mucus removal in NMD patients. To evaluate its efficacy, changes in transcutaneous oxygen saturation (SpO(2)), which may predict intratracheal mucus removal, will be measured before and after use of MI-E. METHODS: This is a single-center, nonblinded, nonrandomized prospective study that will enroll 5 subjects hospitalized in Kobe University Hospital owing to respiratory tract infection. All subjects will receive MI-E therapy a few times daily and will receive HFO every other day, for 6 days. Before and after MI-E use, SpO(2) will be obtained and the change in SpO(2) (ΔSpO(2)) between MI-E with and without HFO will be calculated. For every subject, the average of ΔSpO(2) with or without HFO will be obtained and the null hypothesis that there is a mean change of 0 in the SpO(2) between MI-E with and without HFO will be tested using the paired t test. If the treatment with HFO is found to be statistically significantly superior to the treatment without HFO, the study will conclude that HFO addition is more efficacious than no HFO addition. RESULTS: A total of 2 subjects have already been recruited and enrolled in this study as of August 2018. CONCLUSIONS: This unique protocol will assess the efficacy of adding HFO to MI-E during the acute phase of respiratory tract infection in patients with NMDs. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/12102