title: Early tracheotomy versus prolonged endotracheal intubation in unselected severely ill ICU patients.
abstract: OBJECTIVE
  Although several advantages are attributed to tracheotomy in ICU patients requiring mechanical ventilation (MV), true benefits and the optimal timing of tracheotomy remain controversial. In this study, we compared early tracheotomy (ET) with prolonged intubation (PI) in severely ill patients requiring prolonged MV.
  
  
  METHODS
  Prospective, randomized study.
  
  
  METHODS
  Twenty-five medical and surgical ICUs in France.
  
  
  METHODS
  Patients expected to require MV > 7 days.
  
  
  RESULTS
  Patients were randomised to either (open or percutaneous) ET within 4 days or PI. The primary end-point was 28-day mortality. Secondary end-points were: the incidence of ICU-acquired pneumonia, number of d1-d28 ventilator-free days, time spent in the ICU, 60-day mortality, number of septic episodes, amount of sedation, comfort and laryngeal and tracheal complications. A sample size of 470 patients was considered necessary to obtain a reduction from 45 to 32% in 28-day mortality. After 30 months, 123 patients had been included (ET = 61, PI = 62) in 25 centres and the study was prematurely closed. All group characteristics were similar upon admission to ICU. No difference was found between the two groups for any of the primary or secondary end-points. Greater comfort was the sole benefit afforded by tracheotomy after subjective self-assessment by patients.
  
  
  CONCLUSIONS
  The trial did not demonstrate any major benefit of tracheotomy in a general population of ICU patients, as suggested in a previous meta-analysis, but was underpowered to draw any firm conclusions. The potential advantage of ET may be restricted to selected groups of patients.
authors.affiliation: Intensive Care Unit, Institut Gustave Roussy, 39 rue Camille Desmoulins, 94805 Villejuif Cedex, France. blot@igr.fr
authors.forename: François
authors.initials: F
authors.lastname: Blot
authors.forename: Thomas
authors.initials: T
authors.lastname: Similowski
authors.forename: Jean-Louis
authors.initials: JL
authors.lastname: Trouillet
authors.forename: Patrick
authors.initials: P
authors.lastname: Chardon
authors.forename: Jean-Michel
authors.initials: JM
authors.lastname: Korach
authors.forename: Marie-Alyette
authors.initials: MA
authors.lastname: Costa
authors.forename: Didier
authors.initials: D
authors.lastname: Journois
authors.forename: Guillaume
authors.initials: G
authors.lastname: Thiéry
authors.forename: Muriel
authors.initials: M
authors.lastname: Fartoukh
authors.forename: Isabelle
authors.initials: I
authors.lastname: Pipien
authors.forename: Nicolas
authors.initials: N
authors.lastname: Bruder
authors.forename: David
authors.initials: D
authors.lastname: Orlikowski
authors.forename: Frédéric
authors.initials: F
authors.lastname: Tankere
authors.forename: Isabelle
authors.initials: I
authors.lastname: Durand-Zaleski
authors.forename: Christian
authors.initials: C
authors.lastname: Auboyer
authors.forename: Gérard
authors.initials: G
authors.lastname: Nitenberg
authors.forename: Laurent
authors.initials: L
authors.lastname: Holzapfel
authors.forename: Alain
authors.initials: A
authors.lastname: Tenaillon
authors.forename: Jean
authors.initials: J
authors.lastname: Chastre
authors.forename: Agnès
authors.initials: A
authors.lastname: Laplanche
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003428:Cross Infection / Q000209:etiology / Q000517:prevention & control; D005260:Female; D006801:Humans; D007362:Intensive Care Units; D007442:Intubation, Intratracheal / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D011014:Pneumonia / Q000209:etiology / Q000517:prevention & control; D012121:Respiration, Artificial / Q000009:adverse effects* / Q000379:methods; D016019:Survival Analysis; D014139:Tracheostomy / Q000009:adverse effects*; D015300:Ventilator Weaning; D055815:Young Adult