PHAryngeal electrical STimulation for early decannulation in TRACheotomised stroke patients with neurogenic dysphagia (PHAST-TRAC): a prospective randomised single-blinded trial

Abstract

Background Dysphagia after stroke is common, especially in severely affected, tracheotomised patients. In a pilot trial, pharyngeal electrical stimulation (PES) improved swallowing function in this group of patients. The PHAryngeal electrical STimulation for early decannulation in TRACheotomised stroke patients with neurogenic dysphagia trial (PHAST-TRAC) was designed to replicate and extend this single-centre experience. Methods Patients with recent stroke who required tracheotomy were randomised to receive three days of PES or sham. All patients had the stimulation catheter inserted; sham treatment was applied by connecting the base station to a simulator box instead of the catheter. Randomisation was done via a computerised interactive system with randomisation (stratified by site) in blocks of 4 patients per site. Patients and investigators applying PES were not masked. The primary-endpoint was assessed blinded to treatment assignment by a separate investigator at each site. The primary outcome was readiness for decannulation 24-72 hours post-treatment, assessed using fiberoptic endoscopic evaluation of swallowing and based on a standardised protocol including absence of massive saliva, presence of spontaneous swallows and laryngeal sensation. We planned a sequential statistical analysis of superiority for the primary endpoint. Interim analyses were to be performed after primary outcome data were available for 50 patients (futility), 70 patients, and every additional 10 patients thereafter up to 140. Analysis was by intention-to-treat. The trial was registered as ISRCTN18137204. Findings From 29th May 2015 to 5th July 2017, 69 patients (PES 35, sham 34) from 9 sites (7 acute care hospitals, 2 rehabilitation facilities) in Germany, Austria and Italy were included: PES group mean age 61.7 (SD 13.0) years, 8 (23%) patients with haemorrhagic stroke, median time onset to randomisation 28.0 [IQR 20, 49] days; sham group age 66.8 (10.3) years, 12 (35%) patients with haemorrhagic stroke, onset to randomisation 28.0 [18, 40] days). The Independent Data & Safety Monitoring Board recommended to stop the trial early for efficacy after 70 patients had been recruited and primary endpoint data of 69 patients were available. This decision was approved by the steering committee. 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 up to 30 days or hospital discharge. Adverse events (AEs) were reported in 24 patients (69%) of the PES group and 24 patients (71%) of the sham group. 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). 7 patients (20%) from the PES group and 3 patients (9%) from the sham group died during the study period. None of the patient deaths or SAEs reported were judged to be PES-treatment- or investigational device-related. Interpretation 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. Future trials should confirm whether PES is beneficial in tracheostomised patients who receive stimulation similarly early after stroke and explore its effects in other cohorts.