Randomized, multicenter trial of lateral Trendelenburg versus semirecumbent body position for the prevention of ventilator-associated pneumonia.

PURPOSE: The lateral Trendelenburg position (LTP) may hinder the primary pathophysiologic mechanism of ventilator-associated pneumonia (VAP). We investigated whether placing patients in the LTP would reduce the incidence of VAP in comparison with the semirecumbent position (SRP). METHODS: This was a randomized, multicenter, controlled study in invasively ventilated critically ill patients. Two preplanned interim analyses were performed. Patients were randomized to be placed in the LTP or the SRP. The primary outcome, assessed by intention-to-treat analysis, was incidence of microbiologically confirmed VAP. Major secondary outcomes included mortality, duration of mechanical ventilation, and intensive care unit length of stay. RESULTS: At the second interim analysis, the trial was stopped because of low incidence of VAP, lack of benefit in secondary outcomes, and occurrence of adverse events. A total of 194 patients in the LTP group and 201 in the SRP group were included in the final intention-to-treat analysis. The incidence of microbiologically confirmed VAP was 0.5% (1/194) and 4.0% (8/201) in LTP and SRP patients, respectively (relative risk 0.13, 95% CI 0.02-1.03, p = 0.04). The 28-day mortality was 30.9% (60/194) and 26.4% (53/201) in LTP and SRP patients, respectively (relative risk 1.17, 95% CI 0.86-1.60, p = 0.32). Likewise, no differences were found in other secondary outcomes. Six serious adverse events were described in LTP patients (p = 0.01 vs. SRP). CONCLUSIONS: The LTP slightly decreased the incidence of microbiologically confirmed VAP. Nevertheless, given the early termination of the trial, the low incidence of VAP, and the adverse events associated with the LTP, the study failed to prove any significant benefit. Further clinical investigation is strongly warranted; however, at this time, the LTP cannot be recommended as a VAP preventive measure. CLINICALTRIALS. GOV IDENTIFIER: NCT01138540.

Mini-cardiopulmonary bypass system: results of a prospective randomized study.

BACKGROUND: We studied postoperative mortality and morbidity after coronary artery bypass graft surgery performed using the mini-extracorporeal circulation (MECC) system. METHODS: From June 2001 to June 2002, we randomly enrolled 60 patients who underwent isolated elective coronary artery bypass graft surgery, and were operated on with the MECC system (30 patients: group A) or standard cardiopulmonary bypass (30 patients: group B). Serial blood samples were collected to evaluate the main preoperative, intraoperative, and postoperative clinical and biological variables; and to measure hemolysis, interleukin-6 cytokine, and plasma C-reactive protein release. RESULTS: A more stable hemoglobin level was detected in group A. The platelet count did not show a significant difference between the two groups. Interleukin-6 cytokine release showed higher values in group B, although no difference between groups was statistically significant. The time course of circulating plasma C-reactive protein concentration exhibited the same increase in both groups. Plasma free hemoglobin levels showed higher hemolysis peaks in group B, although a statistical significant difference was detected only at 4 hours after surgery. A higher cardiac index and reduced systemic and pulmonary vascular resistance index in the early postoperative period were found in group A at postoperative time 30 minutes. CONCLUSIONS: Our experience shows that MECC offers satisfactory clinical benefits in terms of good hemodynamic support, safety, and low morbidity, although the study failed to demonstrate a significant clear superiority of MECC versus conventional cardiopulmonary bypass. The results need to be confirmed by a larger prospective, randomized study comparing MECC and standard cardiopulmonary bypass.