Gianluigi Li Bassi1,2,3,4, Mauro Panigada5, Otavio T. Ranzani1,3,4,6, Alberto Zanella5, Lorenzo Berra7, Massimo Cressoni8, Vieri Parrini9, Hassan Kandil10, Giovanni Salati11, Paola Selvaggi12, Alessandro Amatu13, Miquel Sanz-Moncosi14, Emanuela Biagioni15, Fernanda Tagliaferri16, Mirella Furia17, Giovanna Mercurio18, Antonietta Costa16, Tullio Manca16, Simone Lindau19, Jaksa Babel20, Marco Cavana21, Chiara Chiurazzi8, Joan-Daniel Marti1, Dario Consonni5, Luciano Gattinoni22, Antonio Pesenti5, Janine Wiener-Kronish7, Cecilia Bruschi9, Andrea Ballotta10, Pierpaolo Salsi11, Sergio Livigni12, Giorgio Iotti13, Javier Fernandez14, Massimo Girardis15, Maria Barbagallo16, Gabriella Moise17, Massimo Antonelli18, Maria Luisa Caspani16, Antonella Vezzani16, Patrick Meybohm19, Vladimir Gasparovic20, Edoardo Geat21, Marcelo Amato6, Michael Niederman23, Theodor Kolobow24, Antoni Torres1,2,3,4
1Department of Pulmonary and Critical Care Medicine, Hospital Clinic, Barcelona, Spain
2University of Barcelona, Barcelona, Spain
3CIBER Enfermedades Respiratorias (CIBERES), Majorca, Spain
4Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain
5Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, Italy
6Pulmonary Division, InCor, Faculdade de Medicina - University of São Paulo, São Paulo, Brazil
7Massachusetts General Hospital, Boston, USA
8Dipartimento di Fisiopatologia Medico-Chirurgica e dei Trapianti, Universtà degli Studi di Milano, Milan, Italy
9Ospedale Nuovo del Mugello, Borgo San Lorenzo, Italy
10IRCCS Policlinico San Donato, San Donato Milanese, Italy
11Arcispedale S. Maria Nuova - IRCCS, Reggio Emilia, Italy
12Ospedale San Giovanni Bosco, Turin, Italy
13Policlinico San Matteo, Pavia, Italy
14Liver Unit, Hospital Clinic, Barcelona, Spain
15Policlinico di Modena, Modena, Italy
16Azienda Ospedaliero-Universitaria di Parma, Parma, Italy
17Ospedale Città di Sesto San Giovanni, Sesto San Giovanni, Italy
18Fondazione Policlinico Universitario A. Gemelli-Università Cattolica del Sacro Cuore, Rome, Italy
19University Hospital Frankfurt, Frankfurt, Germany
20University Hospital Center Zagreb, Zagreb, Croatia
21Ospedale Santa Chiara, Trento, Italy
22University of Göttingen, Göttingen, Germany
23Weill Cornell Medicine Pulmonary, New York, USA
24National Institutes of Health, Bethesda, USA
Tóm tắt
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). 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. 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). 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. NCT01138540.
