Early tracheotomy versus prolonged endotracheal intubation in unselected severely ill ICU patients
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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.
Prospective, randomized study.
Twenty-five medical and surgical ICUs in France.
Patients expected to require MV > 7 days.
Measurements and 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.
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.
KeywordsTracheotomy Tracheostomy Mechanical ventilation Intensive care unit Critical care ICU-acquired pneumonia Hospital mortality Randomised controlled trial
TRACHEO trial group. Grant from the Délégation à la Recherche Clinique (PHRC 2002) and ANTADIR (Association fédérative Nationale pour le Traitement A Domicile de l’Insuffisance Respiratoire Chronique). The study was endorsed by the French learned societies for Intensive Care Medicine (Société de Réanimation de Langue Française), Anesthesiology (Société Française d’Anesthésie-Réanimation), and Respiratory Medicine (Société de Pneumologie de Langue Française).
Authors thank Lorna Saint Ange for editing; Anne-Marie Flaux and Dominique Meunier for their outstanding efforts in monitoring and planning the study; Antonella Pinna and Anne-Sophie Veillard for invaluable help in data monitoring; Armelle Morin for secretarial assistance; all the staff members of all the participating hospitals and ICUs who were associated with the study; and the members of the Délégation Régionale à la Recherche Clinique, for their help in conducting the study.
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