In stroke patients who received a tracheotomy and developed dysphagia, pharyngeal electrical stimulation (PES) may improve the rate of earlier readiness for decannulation, according to findings from the Pharyngeal Electrical Stimulation for Early Decannulation in Tracheotomised Stroke Patients With Neurogenic Dysphagia (PHAST-TRAC) trial, published in Lancet Neurology.
Patients with recent supratentorial stroke and subsequent tracheotomy from 9 different European sites, including 7 acute care hospitals and 2 rehabilitation facilities, were enrolled in the study (n=69). All patients were unable to undergo decannulation due to severe dysphagia. The study investigators randomly selected patients to undergo either a 3-day PES protocol (n=35) or sham treatment (n=34), with each stimulation lasting 10 minutes/day.
The stimulation catheter was inserted in all patients; application of the sham treatment consisted of “connecting the PES base station to a simulator box instead of the catheter,” according to the researchers. Readiness for decannulation 24 to 72 hours following either PES or sham intervention comprised the primary outcome. The primary outcome was assessed with a fibreoptic endoscopic swallowing evaluation, which was based on the absence of massive saliva pooling, presence of one or more spontaneous swallows, and presence of at least a minimum laryngeal sensation.
A significantly greater percentage of patients in the PES group were ready for decannulation after 3 days of treatment vs the sham control group (49% vs 9%, respectively; odds ratio [OR] 7.00; 95% CI, 2.41–19.88; P =.0008). A similar percentage of participants in the PES and sham control groups experienced adverse events (69% vs 71%, respectively) and the investigators found no difference in the percentage of patients with one or more serious adverse events in either group (29% vs 23%; OR 1.30; 95% CI, 0.44–3.83; P =.7851). Mortality was slightly higher in the PES group; however, this difference did not reach statistical significance (20% PES vs 9% sham control; OR 2.58; 95% CI, 0.61–10.97; P =.3059) and deaths were not deemed attributable to the PES procedure.
Limitations of the PHAST-TRAC trial included the small number of patients and the single-blinded and unmasked administration of PES.
The earlier readiness of decannulation observed in the PES group vs the sham group in patients with post-stroke dysphagia “suggests that a meaningful change in the ability of clinicians to treat these patients might be possible,” the researchers wrote.
Dziewas R, Stellato R, van der Tweel I, et al; for the PHAST-TRAC investigators. Pharyngeal electrical stimulation for early decannulation in tracheotomised patients with neurogenic dysphagia after stroke (PHAST-TRAC): a prospective, single-blinded, randomised trial. Lancet Neurol. 2018;17(10):849-859.