| Early vs late tracheotomy for prevention of pneumonia in mechanically ventilated adult ICU patients: a randomized controlled trial. | |
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MedLine Citation:
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PMID: 20407057 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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CONTEXT: 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. DESIGN, SETTING, AND PATIENTS: 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. INTERVENTION: 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). MAIN OUTCOME MEASURES: 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). CONCLUSION: 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. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00262431. |
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Authors:
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Pier Paolo Terragni; Massimo Antonelli; Roberto Fumagalli; Chiara Faggiano; Maurizio Berardino; Franco Bobbio Pallavicini; Antonio Miletto; Salvatore Mangione; Angelo U Sinardi; Mauro Pastorelli; Nicoletta Vivaldi; Alberto Pasetto; Giorgio Della Rocca; Rosario Urbino; Claudia Filippini; Eva Pagano; Andrea Evangelista; Gianni Ciccone; Luciana Mascia; V Marco Ranieri |
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Publication Detail:
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Type: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: JAMA : the journal of the American Medical Association Volume: 303 ISSN: 1538-3598 ISO Abbreviation: JAMA Publication Date: 2010 Apr |
Date Detail:
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Created Date: 2010-04-21 Completed Date: 2010-04-22 Revised Date: 2010-08-25 |
Medline Journal Info:
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Nlm Unique ID: 7501160 Medline TA: JAMA Country: United States |
Other Details:
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Languages: eng Pagination: 1483-9 Citation Subset: AIM; IM |
Affiliation:
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Anestesia e Rianimazione 1, Ospedale S. Giovanni Battista, Università di Torino, Turin, Italy. |
| Data Bank Information | |
Bank Name/Acc. No.:
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ClinicalTrials.gov/NCT00262431 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adult Aged Female Humans Intensive Care Units Italy Length of Stay Male Middle Aged Pneumonia, Ventilator-Associated / prevention & control* Respiration, Artificial / adverse effects* Time Factors Tracheotomy* |
| Comments/Corrections | |
Comment In:
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Ann Intern Med. 2010 Aug 17;153(4):JC2-9
[PMID:
20713788
]
JAMA. 2010 Apr 21;303(15):1537-8 [PMID: 20407065 ] |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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