A randomized clinical trial for the timing of tracheotomy in critically ill patients: factors precluding inclusion in a single center study.

INTRODUCTION: We investigated the potential benefits of early tracheotomy performed before day eight of mechanical ventilation (MV) compared with late tracheotomy (from day 14 if it still indicated) in reducing mortality, days of MV, days of sedation and ICU length of stay (LOS). METHODS: Randomized controlled trial (RCT) including all-consecutive ICU admitted patients requiring seven or more days of MV. Between days five to seven of MV, before randomization, the attending physician (AP) was consulted about the expected duration of MV and acceptance of tracheotomy according to randomization. Only accepted patients received tracheotomy as result of randomization. An intention to treat analysis was performed including patients accepted for the AP and those rejected without exclusion criteria. RESULTS: A total of 489 patients were included in the RCT. Of 245 patients randomized to the early group, the procedure was performed for 167 patients (68.2%) whereas in the 244 patients randomized to the late group was performed for 135 patients (55.3%) (P <0.004). Mortality at day 90 was similar in both groups (25.7% versus 29.9%), but duration of sedation was shorter in the early tracheotomy group median 11 days (range 2 to 92) days compared to 14 days (range 0 to 79) in the late group (P <0.02). The AP accepted the protocol of randomization in 205 cases (42%), 101 were included in early group and 104 in the late group. In these subgroup of patients (per-protocol analysis) no differences existed in mortality at day 90 between the two groups, but the early group had more ventilator-free days, less duration of sedation and less LOS, than the late group. CONCLUSIONS: This study shows that early tracheotomy reduces the days of sedation in patients undergoing MV, but was underpowered to prove any other benefit. In those patients selected by their attending physicians as potential candidates for a tracheotomy, an early procedure can lessen the days of MV, the days of sedation and LOS. However, the imprecision of physicians to select patients who will require prolonged MV challenges the potential benefits of early tracheotomy. TRIAL REGISTRATION: Controlled-Trials.com ISRCTN22208087 . Registered 27 March 2014.

Effectiveness of pulmonary rehabilitation in reducing health resources use in chronic obstructive pulmonary disease.

OBJECTIVE: To determine the effectiveness of a multidisciplinary, outpatient pulmonary rehabilitation (PR) program in patients with severe and very severe chronic obstructive pulmonary disease (COPD). PR is recommended in advanced COPD, but there is limited evidence on the effectiveness of PR in reducing health care resources when applied in outpatients. DESIGN: Before and after intervention, a prospective research trial of patients enrolled in a PR program. SETTING: Outpatient respiratory department in a specialized hospital. PARTICIPANTS: We considered prospectively 82 consecutive patients with advanced COPD and finally studied 72 patients who completed the PR intensive phase. INTERVENTION: PR program. MAIN OUTCOME MEASURES: The effectiveness of this PR program was assessed by comparing health resources use from the year before and the year after PR. Clinical variables including dyspnea; the body mass index, obstruction, dyspnea, exercise capacity (BODE) index; and the Chronic Respiratory Questionnaire and health resources use including the number of exacerbations, the number of hospitalizations, and days of hospitalization. RESULTS: Patients had a forced expiratory volume in the first second percentage predicted (mean +/- SD) of 33.0+/-9.8 and a BODE index of 5.0+/-2.0. Significant improvements after PR were found in dyspnea, exercise capacity, and quality of life and on the BODE index (P<.05). Compared with the 12 months before PR, there were also significant reductions during the year after PR on exacerbations (3.4+/-3.5 vs 1.9+/-2.0, P=.002), hospitalizations (2.4+/-2.0 vs 0.9+/-1.2, P<.001), and days of hospitalization (36.1+/-32.7 vs 16.1+/-31.3, P<.001) (ie, a reduction of 44%, 63%, and 55%, respectively; all P<.05). CONCLUSIONS: We conclude that a multidisciplinary, outpatient PR program substantially reduces health resources use in patients with severe and very severe COPD.