Early vs late tracheotomy for prevention of pneumonia in mechanically ventilated adult ICU patients: a randomized controlled trial.
BACKGROUND
Tracheotomy is used to replace endotracheal intubation in patients requiring prolonged ventilation; however, there is considerable variability in the time considered optimal for performing tracheotomy. This is of clinical importance because timing is a key criterion for performing a tracheotomy and patients who receive one require a large amount of health care resources.


OBJECTIVE
To determine the effectiveness of early tracheotomy (after 6-8 days of laryngeal intubation) compared with late tracheotomy (after 13-15 days of laryngeal intubation) in reducing the incidence of pneumonia and increasing the number of ventilator-free and intensive care unit (ICU)-free days.


METHODS
Randomized controlled trial performed in 12 Italian ICUs from June 2004 to June 2008 of 600 adult patients enrolled without lung infection, who had been ventilated for 24 hours, had a Simplified Acute Physiology Score II between 35 and 65, and had a sequential organ failure assessment score of 5 or greater.


METHODS
Patients who had worsening of respiratory conditions, unchanged or worse sequential organ failure assessment score, and no pneumonia 48 hours after inclusion were randomized to early tracheotomy (n = 209; 145 received tracheotomy) or late tracheotomy (n = 210; 119 received tracheotomy).


METHODS
The primary endpoint was incidence of ventilator-associated pneumonia; secondary endpoints during the 28 days immediately following randomization were number of ventilator-free days, number of ICU-free days, and number of patients in each group who were still alive.


RESULTS
Ventilator-associated pneumonia was observed in 30 patients in the early tracheotomy group (14%; 95% confidence interval [CI], 10%-19%) and in 44 patients in the late tracheotomy group (21%; 95% CI, 15%-26%) (P = .07). During the 28 days immediately following randomization, the hazard ratio of developing ventilator-associated pneumonia was 0.66 (95% CI, 0.42-1.04), remaining connected to the ventilator was 0.70 (95% CI, 0.56-0.87), remaining in the ICU was 0.73 (95% CI, 0.55-0.97), and dying was 0.80 (95% CI, 0.56-1.15).


CONCLUSIONS
Among mechanically ventilated adult ICU patients, early tracheotomy compared with late tracheotomy did not result in statistically significant improvement in incidence of ventilator-associated pneumonia.


BACKGROUND
clinicaltrials.gov Identifier: NCT00262431.
Terragni
Pier Paolo
PP
Anestesia e Rianimazione 1, Ospedale S. Giovanni Battista, Università di Torino, Turin, Italy.
Antonelli
Massimo
M
Fumagalli
Roberto
R
Faggiano
Chiara
C
Berardino
Maurizio
M
Pallavicini
Franco Bobbio
FB
Miletto
Antonio
A
Mangione
Salvatore
S
Sinardi
Angelo U
AU
Pastorelli
Mauro
M
Vivaldi
Nicoletta
N
Pasetto
Alberto
A
Della Rocca
Giorgio
G
Urbino
Rosario
R
Filippini
Claudia
C
Pagano
Eva
E
Evangelista
Andrea
A
Ciccone
Gianni
G
Mascia
Luciana
L
Ranieri
V Marco
VM
D000328:Adult; D000368:Aged; D005260:Female; D006801:Humans; D007362:Intensive Care Units; D007558:Italy; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D053717:Pneumonia, Ventilator-Associated / Q000517:prevention & control*; D012121:Respiration, Artificial / Q000009:adverse effects*; D013997:Time Factors; D014140:Tracheotomy