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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.

Introduction: Gravity plays a pivotal role in the pathogenesis of ventilator-associated pneumonia (VAP) (1). In previous laboratory studies (2) the semi-lateral Trendelenburg position (LTP) hindered gravity-driven pulmonary aspiration and avoided VAP. Objectives: To determine whether the LTP vs. the semi-recumbent position (SRP) would reduce the incidence of microbiologically confirmed VAP and to appraise patient's compliance and safety. Methods: We conducted a randomized, single-blind, controlled study in 17 European centers and 1 in North America. A total of 2019 adult patients were screened between 2010 and 2015. 395 patients were randomized - 194 in LTP and 201 in SRP - and analyzed in an intention to treat approach. Patients in LTP were placed in semi-lateral (60°) - Trendelenburg position to achieve an orientation, from the sternal notch toward the mouth, slightly below horizontal, and turned from one side to the other every 6 hours. LTP was encouraged during the first days of mechanical ventilation, but always in compliance with the patient's wish. In the SRP group, the head of the bed was elevated ≥ 30°. Primary outcome was VAP incidence rate, based on quantitative bronchoalveolar lavage fluid culture with ≥ 104 colonyforming units/mL. Secondary outcomes were compliance to the randomized position, length of intubation, duration of intensive care unit and hospital stay, mortality, and adverse events. Results: The trial was stopped after the planned interim analysis for achieving efficacy endpoints and owing to safety concerns. Patients in the LTP and SRP group were kept in the randomized position for 38 % and 90 % of the study time, respectively (p = 0.001). Yet, during the first 48 hours, LTP patients were kept in the randomized position for 50 % of the study time, and SRP patients for 88 % (p = 0.001). In the LTP, the bed was angulated 5.6° in Trendelenburg; while, the head of the bed was elevated 34.1° in the SRP group. Incidence rates of microbiologically confirmed VAP were 0.88 (1/1136 patient-days; 95 % confidence interval [CI], 0.12-6.25) in the LTP group, and 7.19 (8/1113 patient-days; CI 95 %, 3.60-14.37) in the SRP (p = 0.020), relative risk reduction of 0.12 (95 % CI, 0.01-0.91). No statistically significant differences were observed in durations of mechanical ventilation, intensive care unit and hospital stay, and mortality. Vomiting was more common in LTP patients (8.3 % vs. 2.5 % in the SRP, p = 0.013). Conclusions: Critically ill patients positioned in the LTP had a statistically significant reduction in the incidence of VAP, compared with those positioned in the SRP. A comprehensive evaluation of potential LTP contraindications is warranted to enhance safety.