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Effect of pressure support versus unassisted breathing through a tracheostomy collar on weaning duration in patients requiring prolonged mechanical ventilation: a randomized trial
Jubran A, Grant BJB, Duffner LA, Collins EG, Lanuza DM, Hoffman LA, Tobin MJ
JAMA 2013 Feb 20;309(7):671-677
clinical trial
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

IMPORTANCE: Patients requiring prolonged mechanical ventilation (> 21 days) are commonly weaned at long-term acute care hospitals (LTACHs). The most effective method of weaning such patients has not been investigated. OBJECTIVE: To compare weaning duration with pressure support versus unassisted breathing through a tracheostomy collar in patients transferred to an LTACH for weaning from prolonged ventilation. DESIGN, SETTING, AND PARTICIPANTS: Between 2000 and 2010, a randomized study was conducted in tracheotomized patients transferred to a single LTACH for weaning from prolonged ventilation. Of 500 patients who underwent a 5-day screening procedure, 316 did not tolerate the procedure and were randomly assigned to receive weaning with pressure support (n = 155) or a tracheostomy collar (n = 161). Survival at 6- and 12-month time points was also determined. MAIN OUTCOME MEASURE: Primary outcome was weaning duration. Secondary outcome was survival at 6 and 12 months after enrollment. RESULTS: Of 316 patients, 4 were withdrawn and not included in analysis. Of 152 patients in the pressure-support group, 68 (44.7%) were weaned; 22 (14.5%) died. Of 160 patients in the tracheostomy collar group, 85 (53.1%) were weaned; 16 (10.0%) died. Median weaning time was shorter with tracheostomy collar use (15 days; interquartile range (IQR), 8 to 25) than with pressure support (19 days; IQR 12 to 31), p = 0.004. The hazard ratio (HR) for successful weaning rate was higher with tracheostomy collar use than with pressure support (HR 1.43; 95% CI 1.03 to 1.98; p = 0.033) after adjusting for baseline clinical covariates. Use of the tracheostomy collar achieved faster weaning than did pressure support among patients who did not tolerate the screening procedure between 12 and 120 hours (HR 3.33; 95% CI 1.44 to 7.70; p = 0.005), whereas weaning time was equivalent with the 2 methods in patients who did not tolerate the screening procedure within 0 to 12 hours. Mortality was equivalent in the pressure-support and tracheostomy collar groups at 6 months (55.92% versus 51.25%; 4.67% difference 95% CI -6.4% to 15.7%) and at 12 months (66.45% versus 60.00%; 6.45% difference 95% CI -4.2% to 17.1%). CONCLUSION AND RELEVANCE: Among patients requiring prolonged mechanical ventilation and treated at a single long-term care facility, unassisted breathing through a tracheostomy, compared with pressure support, resulted in shorter median weaning time, although weaning mode had no effect on survival at 6 and 12 months. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT01541462.

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