Effect of Oral Neuromuscular Training on Tracheostomy Decannulation and Swallowing Function in Patients with Severe Acquired Brain Injury: A Pilot Randomized Controlled Trial.

The study was a pilot with only 22 enrolled and 20 completed, so chance findings are likely. The primary outcome was not statistically significant, so the hazard ratio favouring IQoro should not be read as proof of benefit. Decannulation and swallowing assessment were not done by blinded assessors. Participants had severe acquired brain injury and low consciousness, so results may not apply to less severe acquired brain injury or non-tracheostomized patients. The power calculation was based on a previous study that may have bias, and that study's usual care was not described in detail. Treatment fidelity was affected by participants sleeping, agitated behaviour, and leaving the ward; adherence was a median of 82%. Baseline pharyngeal residue was borderline higher in the usual care group, which may affect residue findings.

Funding was named as Regional hospital central Jutland Research Foundation and Aarhus Universitet.

Do not read the trend toward faster decannulation as proof that IQoro works. The primary outcome was not statistically significant. Do not treat the worse residue finding as proven harm. It may be a chance finding because the study was small.