Abstract
Background: Dysphagia is common after stroke and associated with a poor outcome. Pharyngeal electrical stimulation (PES) increased decannulation rates in tracheotomised stroke patients with dysphagia following ventilation in two trials. We report the results of an individual patient data meta-analysis assessing PES in severely dysphagic tracheotomised stroke patients. Methods: We searched for randomised controlled trials of PES in dysphagic tracheotomised stroke patients and obtained individual patient data for demographic and clinical (stroke severity, NIHSS; functional oral intake scale, FOIS; decannulation) variables from trialists. Data are number (%), median [interquartile range], mean (standard deviation) and mean difference (MD) or odds ratio (OR) with 95% confidence intervals (CI). Results: Two completed trials were identified (n=30, PHAST-TRAC n=69 [funded by Phagenesis Ltd]), with data for 99 participants (PES 55, 56%; sham 44, 44%). Mean age 64 (13) years, female 40 (40%), NIHSS 18 [14-21], time from onset to randomisation 27 days [20-38], and FOIS=1 (nil by mouth). As compared with sham, PES was associated with an increased proportion of patients who were ready for early decannulation, 59% versus 11% (OR 11.4, 95% CI 3.86-33.33; p<0.001) and improved FOIS score at discharge (MD 1.13, 95% CI 0.25-2.00; p=0.011). Treated participants who were ready for decannulation tended to have a shorter hospital length of stay: 23 vs 41 days (p=0.070) than those who were not ready. No device-related serious adverse events were reported. Conclusions: PES was associated with an increased proportion of stroke patients who were ready for decannulation and less dysphagia, in two randomised trials.
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