title: A randomized clinical trial for the timing of tracheotomy in critically ill patients: factors precluding inclusion in a single center study.
abstract: BACKGROUND
  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.
  
  
  BACKGROUND
  Controlled-Trials.com ISRCTN22208087 . Registered 27 March 2014.
authors.affiliation: Servei de Medicina Intensiva, Hospital Universitari de Bellvitge, C/Feixa Llarga, Hospitalet de Llobregat, Barcelona, 08907, Spain. adiazprietoh@bellvitgehospital.cat.
authors.forename: Antonio
authors.initials: A
authors.lastname: Diaz-Prieto
authors.affiliation: Servei de Medicina Intensiva, Hospital Universitari de Bellvitge, C/Feixa Llarga, Hospitalet de Llobregat, Barcelona, 08907, Spain. mateu@bellvitgehospital.cat.
authors.forename: Antoni
authors.initials: A
authors.lastname: Mateu
authors.affiliation: Servei de Medicina Intensiva, Hospital Universitari de Bellvitge, C/Feixa Llarga, Hospitalet de Llobregat, Barcelona, 08907, Spain. tgorriz@bellvitgehospital.cat.
authors.forename: Maite
authors.initials: M
authors.lastname: Gorriz
authors.affiliation: Departament de Gerencia, Hospital Universitari de Bellvitge, C/Feixa Llarga, Hospitalet de Llobregat, Barcelona, 08907, Spain. bertao@bellvitgehospital.cat.
authors.forename: Berta
authors.initials: B
authors.lastname: Ortiga
authors.affiliation: Servei de Medicina Intensiva, Hospital Universitari de Bellvitge, C/Feixa Llarga, Hospitalet de Llobregat, Barcelona, 08907, Spain. truchero@bellvitgehospital.cat.
authors.forename: Consol
authors.initials: C
authors.lastname: Truchero
authors.affiliation: Servei de Medicina Intensiva, Hospital Universitari de Bellvitge, C/Feixa Llarga, Hospitalet de Llobregat, Barcelona, 08907, Spain. nsampietro@bellvitgehospital.cat.
authors.forename: Neus
authors.initials: N
authors.lastname: Sampietro
authors.affiliation: Servei de Medicina Intensiva, Hospital Universitari de Bellvitge, C/Feixa Llarga, Hospitalet de Llobregat, Barcelona, 08907, Spain. mferrer@bellvitgehospital.cat.
authors.forename: María Jesus
authors.initials: MJ
authors.lastname: Ferrer
authors.affiliation: Servei de Medicina Intensiva, Hospital Universitari de Bellvitge, C/Feixa Llarga, Hospitalet de Llobregat, Barcelona, 08907, Spain. rmanez@bellvitgehospital.cat.
authors.forename: Rafael
authors.initials: R
authors.lastname: Mañez
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016638:Critical Illness / Q000453:epidemiology / Q000628:therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012121:Respiration, Artificial / Q000379:methods / Q000639:trends*; D013997:Time Factors; D014140:Tracheotomy / Q000379:methods / Q000639:trends*; D055815:Young Adult