Safety and efficacy of Staged Extubation Set in patients with difficult airway: a prospective multicenter study

BACKGROUND: A safe extubation is the extension of any airway management strategy. Despite different guidelines, a number of extubation accidents still occurs. Re-intubation failure could be fatal, thus a strategy and safe and efficient devices for this purpose are essential. METHODS: Multicentric prospective observational study on adult patients with endotracheal intubation and known difficult airway. A Staged Extubation Set® (SES) was used for extubation. Demographics, ASA, El Ganzouri, type of surgery, re-intubation success/failure and complications were recorded. The aim of the study was the assessment of the rate of re intubation failure, complications during failures, patients' comfort and evidence of airway injury. RESULTS: Overall, 114 subsequent difficult airway patients were enrolled. Fifteen patients (13%) required re-intubation: ten of 15 (66%) were successfully re-intubated, with a first-pass success rate of 100%. In five patients (33%), re-intubation over SES was unsuccessful, with re-intubation difficulty rate three (easy), three (quite easy) and nine (very difficult) and five cases of desaturation. Complications included one case of esophageal intubation, one case of lip trauma, and two cases of airway edema. Of 114 patients, eight (7%) perceived the procedure as intolerable. CONCLUSIONS: The results from this study show a relatively satisfactory success rate with a relatively high number of re-intubations failure and a low incidence of complications when using a SES in a cohort of difficult airway patients, all failures due to guidewire dislodgement during or after extubation. Further research is needed to improve success rate; at the same time the need for an extubation protocol is strongly advocated.