title: Reduced burden of bacterial airway colonization with a novel silver-coated endotracheal tube in a randomized multiple-center feasibility study.
abstract: OBJECTIVE
  To assess the feasibility and safety of the respiratory infection control (RIC) device, a silver-coated endotracheal tube, and its effect on bacterial burden in the airways.
  
  
  METHODS
  Prospective, randomized, single-blind, multiple-center study.
  
  
  METHODS
  Three hospitals in Spain and one in the United States.
  
  
  METHODS
  Patients were eligible adults who required mechanical ventilation for > or =24 hrs and did not have respiratory infections. One hundred forty-nine patients were intubated and analyzed for safety; 121 were intubated > or =24 hrs and analyzed for tube colonization; 67 had negative baseline quantitative endotracheal aspirates and were analyzed for quantitative endotracheal aspirates colonization.
  
  
  METHODS
  Intubation with the RIC device or a control endotracheal tube.
  
  
  RESULTS
  The RIC device was associated with delayed colonization on the tube compared with the control device at the threshold of ++, +++, or > or =10(4) colony-forming units/mL (p = .02, log-rank test; p = .10, Wilcoxon's test) and in quantitative endotracheal aspirates at > or =10(6) colony-forming units/mL (p = .08, log-rank test; p = .05, Wilcoxon's test). The RIC device was associated with reduced colonization rate by days on the tube (p = .04, Wilcoxon's test) and in quantitative endotracheal aspirates (p = .05, Wilcoxon's test) at the same thresholds. The RIC device was associated with lower maximal bacterial burden in tracheal aspirates for 7 days (mean log-transformed burden, 4.2 +/- 2.3 vs. 5.5 +/- 1.7 log colony-forming units/mL; p = .02, Wilcoxon's test). Other between-group differences favored the RIC device but were not significant. Five adverse events were considered device related, including three events in the RIC group and two events in the control group.
  
  
  CONCLUSIONS
  In this prospectively planned, preliminary analysis, the RIC device was feasible and well tolerated. Larger studies are needed to determine whether delayed colonization, reduced colonization rate, and decreased bacterial burden will decrease the incidence of ventilator-associated pneumonia.
authors.affiliation: Critical Care Department, Joan XXIII University Hospital, Tarragona, Spain. jrello.hj23.ics@gencat.net
authors.forename: Jordi
authors.initials: J
authors.lastname: Rello
authors.forename: Marin
authors.initials: M
authors.lastname: Kollef
authors.forename: Emili
authors.initials: E
authors.lastname: Diaz
authors.forename: Albert
authors.initials: A
authors.lastname: Sandiumenge
authors.forename: Yolanda
authors.initials: Y
authors.lastname: del Castillo
authors.forename: Xavier
authors.initials: X
authors.lastname: Corbella
authors.forename: Regina
authors.initials: R
authors.lastname: Zachskorn
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D020099:Coated Materials, Biocompatible; D015169:Colony Count, Microbial; D003428:Cross Infection / Q000209:etiology / Q000517:prevention & control*; D004866:Equipment Contamination / Q000517:prevention & control; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007442:Intubation, Intratracheal / Q000009:adverse effects / Q000295:instrumentation*; D008297:Male; D008875:Middle Aged; D011015:Pneumonia, Aspiration / Q000209:etiology / Q000517:prevention & control*; D012121:Respiration, Artificial / Q000009:adverse effects / Q000379:methods*; D012834:Silver; D016037:Single-Blind Method; D013030:Spain; D014481:United States
chemical_list: D020099:Coated Materials, Biocompatible; D012834:Silver