OBJECTIVE: To evaluate the feasibility of adding mechanical insufflation-exsufflation (MI-E) to a weaning protocol for tracheostomized patients undergoing prolonged mechanical ventilation (MV). DESIGN: Single-center, open-label, randomized, controlled pilot and feasibility study. SETTING: Intensive care unit in Brazil. PATIENTS: Tracheostomized adults who were invasively ventilated for more than 14 days and who were weaned from MV. INTERVENTIONS: Patients were randomized into two groups: intervention group (IG) or a control group (CG). During weaning with a tracheostomy collar, the IG received two daily sessions of MI-E, each with 5 cycles (insufflation and exsufflation pressures of 45cm H2O). The CG received conventional chest physiotherapy. MAIN VARIABLES OF INTEREST: The primary outcomes were the feasibility of adding MI-E to the weaning protocol and the rate of successful weaning. RESULTS: A total of 47 patients were randomized, with 25 in the IG and 22 in the CG. All patients randomized to the MI-E group received the proposed protocol, completing all the scheduled MI-E sessions. Adverse events occurred in 14% of the MI-E sessions, but they did not lead to treatment interruption. Weaning success was observed in 76% of IG patients and 73% of CG patients (relative risk 1.05; 95% CI 0.75 to 1.46). No significant differences were observed between the IG and CG regarding ICU mortality (16% and 18%, respectively, p = 0.99) or hospital mortality (40% and 41%, respectively, p = 0.99). CONCLUSIONS: The addition of MI-E to the standard weaning protocol is feasible, but not result in a greater rate of successful weaning in tracheostomized patients. CLINICAL TRIAL REGISTRATION NUMBER: U1111-1302-9035.

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