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Objective To estimate the relative effect of early vs.late tracheotomy on clinical end-points in unselected intensive care unit(ICU)patients undergoing mechanical ventilation.Methods We searched electronic databases(up to February 27,2013)for both randomized control trials and observational studies satisfying the predefined inclusion criteria.Results We retrieved 11 reports of studies including a total of 13 705 patients.Early tracheotomy was associated with significant reductions in mortality[33.3%vs.36.3%;relative risk(RR);0.92;95%confidence interval(CI):0.88,0.97;I2:29%],length of ICU stay(mean difference:6.55 days;95%CI:8.19,4.90;I2:98%)and duration of mechanical ventilation(mean difference:6.53 days;95%CI:11.43,1.63;I2:100%).However,as compared with late tracheotomy,early tracheotomy did not reduce the incidence of hospital pneumonia(21.9%vs.21.0%,RR:0.85;95%CI:0.68,1.06;I2:67%).Conclusions Early tracheotomy can reduce length of ICU stay,duration of mechanical ventilation and mortality but has no influence on hospital pneumonia when compared with late tracheotomy.Once the decision has been made about tracheotomy,clinical physicians should not hesitate to perform the procedure.