Accelerating tracheostomy decannulation with intermittent oro-esophageal feeding in neurogenic dysphagia: a multicenter randomized controlled trial

Neurogenic dysphagia frequently constitutes a major barrier to decannulation for tracheostomized patients. Conventional nasogastric tube (NGT) feeding may promote disuse atrophy of swallowing musculature and persistent aspiration risk. Intermittent oro-esophageal tube (IOE) feeding, a physiologically oriented modality mimicking natural swallowing, may accelerate decannulation, yet high-quality evidence is lacking.

In this multicenter randomized controlled trial conducted at three tertiary academic centers in China, tracheostomized adults with neurogenic dysphagia were randomly assigned 1:1 to IOE or NGT. All participants received standardized pharmacological treatment, pulmonary rehabilitation, and structured swallowing training, and entered an institutional decannulation protocol with predefined readiness criteria. The primary outcome was time from protocol entry to actual decannulation. Secondary outcomes included the 30-day successful decannulation rate, nutritional indices, swallowing function, and swallowing-related quality of life. Outcome assessors and statisticians were blinded to allocation. Analyses followed the intention-to-treat principle.

A total of 140 patients were randomized to IOE (n = 70) or NGT (n = 70). Time to decannulation was shorter with IOE (22.16 ± 1.86 vs. 26.33 ± 1.30 days; between-group difference, 4.17 days; 95% confidence interval [CI], 1.90-6.44; p < 0.001; log-rank p = 0.005). The 30-day successful decannulation rate was higher with IOE (65.71% vs. 47.14%; absolute difference, 18.57% points; 95% CI, 2.43-34.71; p = 0.028). At 1 month, the IOE group demonstrated greater improvements in body mass index, serum albumin, serum prealbumin, swallowing function, and swallowing-related quality of life (all p < 0.001). Pharyngeal discomfort was less frequent with IOE (14.06% vs. 34.21%; p = 0.006); no Grade Ⅲ or higher adverse events occurred.

Intermittent oro-esophageal tube feeding shortens time to decannulation and improves nutritional, swallowing, and quality-of-life outcomes compared with nasogastric tube feeding in tracheostomized patients with neurogenic dysphagia.

ClinicalTrials.gov, NCT06791590, registration date January 19, 2025.