Safety and efficacy of a 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(R) (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: 114 subsequent difficult airway patients were enrolled. 15 patients (13%) required re- intubation: 10 out 15 (66%) were successfully re-intubated, with a first-pass success rate of 100%. In 5 patients (33%) re-intubation over SES was unsuccessful, with re-intubation difficulty rate 3 (easy), 3 (quite easy) and 9 (very difficult) and 5 cases of desaturation. Complications included 1 esophageal intubation, 1 lip trauma and 2 airway edema. Out of 114 patients, 8 (7%) judged the procedure intolerable. CONCLUSIONS: Our study showed 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.