A trial of pharyngeal electrical stimulation in stroke patients with tracheotomy
Pharyngeal electrical stimulation for early decannulation in tracheotomised patients with neurogenic dysphagia after stroke (PHAST-TRAC): a prospective, single-blinded, randomised trial.
Dziewas R, Stellato R, van der Tweel I, Walther E, Werner CJ, Braun T, Citerio G, Jandl M, Friedrichs M, Nötzel K, Vosko MR, Mistry S, Hamdy S, McGowan S, Warnecke T, Zwittag P, Bath PM, PHAST-TRAC investigators
In a pilot trial, pharyngeal electrical stimulation (PES) improved swallowing function in this group of patients.
Dysphagia after stroke is common, especially in severely affected, tracheotomised patients. The PHAryngeal electrical STimulation for early decannulation in TRACheotomised stroke patients with neurogenic dysphagia trial (PHAST-TRAC) was designed to assess efficacy of pharyngeal stimulation in this population.
Patients with recent stroke who required tracheotomy were randomised to receive three days of PES or sham. The primary outcome was readiness for decannulation 24-72 hours post-treatment, assessed using fiberoptic endoscopic evaluation of swallowing. Analysis was by intention-to-treat.
69 patients (PES 35, sham 34) from 9 sites in Germany, Austria and Italy were included: PES was associated with more patients being ready for decannulation as compared to sham: 17 (49%) vs. 3 (9%), odds ratio (OR) 7.00 (2.41-19.88), p=0.00082).
No patient required recannulation within 48 hours or during their documented follow-up period. The number of patients with at least one serious adverse event (SAE) did not differ between the groups: 10 (29%) vs. 8 (23%), OR 1.3 (0.44-3.83), p=0.7851).
PES increased the proportion of patients with stroke and subsequent tracheotomy who were ready for decannulation in this study population, many of whom received PES within a month of their stroke.
- This work has found that pharyngeal stimulation can be used as a treatment for accelerating decannulation of tracheotomies in severely dysphagic stroke patients.
- This group of patients currently have no alternative treatment options, so advances in this field are rare.
- The work opens the door to a new era of neurostimulation as a treatment for neurogenic dysphagia, a common, distressing but poorly managed condition with life threatening complications.
- School of Medicine, University of Nottingham
- Otto Creutzfeldt Center for Cognitive and Behavioral Neuroscience (OCC), University of Munster
- Nestle Health Science: Phagenesis announces the publication of its recent randomised controlled trial confirming the benefits of Phagenyx
- Medscape: Pharyngeal electrical stimulation shows promise in post-stroke dysphagia (login required)
- Market Watch: Multicentre randomised controlled trial confirms the significant benefits of Phagenyx treatment for tracheostomised stroke patients with dysphagia
- Practical Neurology: Neuromodulation effective for dysphagia in patients who experience stroke and reduces length of hospital stay
Sponsored by Phagenesis Ltd.