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.

Integron presence in a multiresistant Morganella morganii isolate.

A multiresistant strain of Morganella morganii was isolated from a patient affected by several severe pathologies. The isolate was found to be resistant to the following antimicrobials: ampicillin, nalidixic acid, cefalothin, cefoxitin, ceftriaxone, ciprofloxacin, chloramphenicol, streptomycin, erythromycin, gentamicin, novobiocin, penicillin, rifampicin, tetracycline and violet crystal. Mechanisms leading to this multiresistance were studied. Porins of M. morganii multiresistant and wild-type strains were analysed by sodium dodecylsulphate-polyacrylamide gel electrophoresis (SDS-PAGE) and were characterised by their ability to form channels in planar black lipid bilayers. The channels formed by porins from multiresistant and susceptible strains suggested that the porins of the multiresistant strain were not responsible for resistance. A 6.6 kb plasmid (pML2003) was detected, isolated and studied. pML2003 included two integrons. Direct sequencing revealed that one of the integrons contained two cassettes, aminoglycoside adenyltransferase (aadB) and chloramphenicol acetyltransferase (catB3) conferring resistance to aminoglycosides and chloramphenicol, respectively. The second integron contained carbenicillinase (blaP1b) and adenyltransferase (aadA2), which confer resistance to beta-lactamases and streptomycin, respectively.