A randomised crossover trial examining the perceived clinical benefits of fenestrated tracheostomy tubes in head and neck patients

Background: A fenestrated tracheostomy tube is believed to improve airflow through a patient's upper airway when corked, and hence aid decannulation. They are however associated with extra morbidity, such as tracheal granulation tissue formation. The aim of this study was to assess if fenestrated uncuffed tracheostomy tubes do confer benefit in airflow, given their increased morbidity profile. This was achieved by alternating a fenestrated or non-fenestrated inner cannula within an uncuffed fenestrated outer cannula which had been corked. Methods: The study was a randomised, non-blinded crossover comparison of airflow (fenestrated versus non-fenestrated inner cannulas) to detect changes in airflow. Participants were adult tracheostomised patients admitted under the Ears Nose & Throat and Oral Maxillofacial Surgical teams at Royal Adelaide Hospital, Australia. Patients were randomised by computer-generated random sequence to the order of inner cannula insertion (ABAB or BABA) and underwent assessment 60 minutes following each cannula change. Outcome measures were peak expiratory flow (PEF), forced expiratory volume in 1 second (FEV1), and maximum phonation time (MPT). Results: Of 28 participants (14 in each arm), there was no difference in PEF, FEV1, or MPT between fenestrated and non-fenestrated cannulas (P=0.66, P=0.93, P=0.66, respectively). Fenestration malposition was observed in 71% of participants (90% in males, 25% in females). Three of eight females tolerated the fenestrated cannula better than the non-fenestrated. Conclusions: In a head and neck surgical population, fenestrated uncuffed tracheostomy tubes provide no advantage in airflow when corked and have a high incidence of malposition in the early post-operative period, particularly in males. In females with small tracheal size, fenestrated uncuffed tracheostomy tubes may still offer clinical benefit. Clinical Trial Registration: Australia and New Zealand Clinical Trials Registry ACTRN12621001384842 (https://www.anzctr.org.au/).