PURPOSE: To determine the effects of deflating the tracheal cuff during disconnections from mechanical ventilation (MV) in tracheostomized patients. METHODS: This was a single-center, randomized trial conducted in a general ICU of a tertiary hospital with regional referral for trauma patients. Patients at high risk of aspiration based on the drink test were excluded. Critically ill tracheostomized patients were randomized to have the tracheal cuff deflated or not during spontaneous breathing trials. Weaning was protocolized on progressive T-tube trials, and patients were considered weaned after 24 consecutive hours disconnected from MV. The primary end point was time to definitive withdrawal of MV; secondary end points were ventilator-associated respiratory infection (pneumonia and/or tracheobronchitis) and swallowing function. Statistical analyses included Cox proportional risk models. RESULTS: We randomized 195 patients and 181 patients completed the study (94 patients with deflated cuff and 87 with inflated cuff). Variables independently related to weaning time in the multivariate analysis were tracheostomy-to-first MV disconnection time (HR 0.5, 95 % CI 0.3-0.8; p < 0.01) and cuff deflation (HR 2.2, 95 % CI 1.5-3; p < 0.01). Respiratory infection was lower in the deflated group (20 vs. 36 %; p = 0.02). Swallowing function improved more in the deflated group (31 vs. 22 %; p = 0.02). CONCLUSION: Under the conditions of our protocol, deflating the tracheal cuff in tracheostomized patients shortens weaning, reduces respiratory infections, and probably improves swallowing.
RCT Entities:
PURPOSE: To determine the effects of deflating the tracheal cuff during disconnections from mechanical ventilation (MV) in tracheostomized patients. METHODS: This was a single-center, randomized trial conducted in a general ICU of a tertiary hospital with regional referral for traumapatients. Patients at high risk of aspiration based on the drink test were excluded. Critically ill tracheostomizedpatients were randomized to have the tracheal cuff deflated or not during spontaneous breathing trials. Weaning was protocolized on progressive T-tube trials, and patients were considered weaned after 24 consecutive hours disconnected from MV. The primary end point was time to definitive withdrawal of MV; secondary end points were ventilator-associated respiratory infection (pneumonia and/or tracheobronchitis) and swallowing function. Statistical analyses included Cox proportional risk models. RESULTS: We randomized 195 patients and 181 patients completed the study (94 patients with deflated cuff and 87 with inflated cuff). Variables independently related to weaning time in the multivariate analysis were tracheostomy-to-first MV disconnection time (HR 0.5, 95 % CI 0.3-0.8; p < 0.01) and cuff deflation (HR 2.2, 95 % CI 1.5-3; p < 0.01). Respiratory infection was lower in the deflated group (20 vs. 36 %; p = 0.02). Swallowing function improved more in the deflated group (31 vs. 22 %; p = 0.02). CONCLUSION: Under the conditions of our protocol, deflating the tracheal cuff in tracheostomized patients shortens weaning, reduces respiratory infections, and probably improves swallowing.
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