TY  - JOUR
A1  - Panigada, Mauro
A1  - Li Bassi, Gianluigi
A1  - Ranzani, Otavio T.
A1  - Kolobow, Theodor
A1  - Zanella, Alberto
A1  - Cressoni, Massimo
A1  - Berra, Lorenzo
A1  - Parrini, Vieri
A1  - Kandil, Hassan
A1  - Salati, Giovanni
A1  - Livigni, Sergio
A1  - Amatu, Alessandro
A1  - Andreotti, Andreotti
A1  - Tagliaferri, Fernanda
A1  - Moise, Gabriella
A1  - Mercurio, Giovanna
A1  - Costa, Antonietta
A1  - Vezzani, Antonella
A1  - Lindau, Simone
A1  - Babel, Jaksa
A1  - Cavana, Marco
A1  - Consonni, Dario
A1  - Pesenti, Antonio
A1  - Gattinoni, Luciano
A1  - Torres, Antoni
T1  - Multicenter randomized clinical trial of lateral-trendelenburg vs. semi recumbent position for the prevention of ventilatorassociated pneumonia - the gravity-VAP trial
T2  - Intensive Care Medicine Experimental
N2  - 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.
Y1  - 2016
UR  - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/55029
UR  - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-550299
SN  - 2197-425X
N1  - Teil von: ESICM LIVES 2016: part one : Milan, Italy. 1-5 October 2016, erschienen in: Intensive Care Medicine Experimental, 4.2016, Supplement 1, doi:10.1186/s40635-016-0098-x
N1  - Open Access: This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
VL  - 4
IS  - Supplement 1, A23
SP  - 14
EP  - 14
PB  - Springer Open
CY  - Berlin ; Heidelberg
ER  -