Gianluigi Li Bassi1,2,3,4, Mauro Panigada5, Otavio T Ranzani6,7,8,9, Alberto Zanella5, Lorenzo Berra10, Massimo Cressoni11, Vieri Parrini12, Hassan Kandil13, Giovanni Salati14, Paola Selvaggi15, Alessandro Amatu16, Miquel Sanz-Moncosi17, Emanuela Biagioni18, Fernanda Tagliaferri19, Mirella Furia20, Giovanna Mercurio21, Antonietta Costa19, Tullio Manca19, Simone Lindau22, Jaksa Babel23, Marco Cavana24, Chiara Chiurazzi11, Joan-Daniel Marti6, Dario Consonni5, Luciano Gattinoni25, Antonio Pesenti5, Janine Wiener-Kronish10, Cecilia Bruschi12, Andrea Ballotta13, Pierpaolo Salsi14, Sergio Livigni15, Giorgio Iotti16, Javier Fernandez17, Massimo Girardis18, Maria Barbagallo19, Gabriella Moise20, Massimo Antonelli21, Maria Luisa Caspani19, Antonella Vezzani19, Patrick Meybohm22, Vladimir Gasparovic23, Edoardo Geat24, Marcelo Amato9, Michael Niederman26, Theodor Kolobow27, Antoni Torres6,28,7,8. 1. Department of Pulmonary and Critical Care Medicine, Hospital Clinic, Calle Villarroel 170, Esc 6/8 Planta 2, 08036, Barcelona, Spain. glibassi@clinic.cat. 2. University of Barcelona, Barcelona, Spain. glibassi@clinic.cat. 3. CIBER Enfermedades Respiratorias (CIBERES), Majorca, Spain. glibassi@clinic.cat. 4. Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain. glibassi@clinic.cat. 5. Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico, Milan, Italy. 6. Department of Pulmonary and Critical Care Medicine, Hospital Clinic, Calle Villarroel 170, Esc 6/8 Planta 2, 08036, Barcelona, Spain. 7. CIBER Enfermedades Respiratorias (CIBERES), Majorca, Spain. 8. Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain. 9. Pulmonary Division, InCor, Faculdade de Medicina - University of São Paulo, São Paulo, Brazil. 10. Massachusetts General Hospital, Boston, USA. 11. Dipartimento di Fisiopatologia Medico-Chirurgica e dei Trapianti, Universtà degli Studi di Milano, Milan, Italy. 12. Ospedale Nuovo del Mugello, Borgo San Lorenzo, Italy. 13. IRCCS Policlinico San Donato, San Donato Milanese, Italy. 14. Arcispedale S. Maria Nuova - IRCCS, Reggio Emilia, Italy. 15. Ospedale San Giovanni Bosco, Turin, Italy. 16. Policlinico San Matteo, Pavia, Italy. 17. Liver Unit, Hospital Clinic, Barcelona, Spain. 18. Policlinico di Modena, Modena, Italy. 19. Azienda Ospedaliero-Universitaria di Parma, Parma, Italy. 20. Ospedale Città di Sesto San Giovanni, Sesto San Giovanni, Italy. 21. Fondazione Policlinico Universitario A. Gemelli-Università Cattolica del Sacro Cuore, Rome, Italy. 22. University Hospital Frankfurt, Frankfurt, Germany. 23. University Hospital Center Zagreb, Zagreb, Croatia. 24. Ospedale Santa Chiara, Trento, Italy. 25. University of Göttingen, Göttingen, Germany. 26. Weill Cornell Medicine Pulmonary, New York, NY, USA. 27. National Institutes of Health, Bethesda, MD, USA. 28. University of Barcelona, Barcelona, Spain.
Abstract
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.
RCT Entities:
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.
Authors: David K Warren; Sunita J Shukla; Margaret A Olsen; Marin H Kollef; Christopher S Hollenbeak; Michael J Cox; Max M Cohen; Victoria J Fraser Journal: Crit Care Med Date: 2003-05 Impact factor: 7.598
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Authors: Denise Battaglini; Chiara Robba; Andrea Fedele; Sebastian Trancǎ; Samir Giuseppe Sukkar; Vincenzo Di Pilato; Matteo Bassetti; Daniele Roberto Giacobbe; Antonio Vena; Nicolò Patroniti; Lorenzo Ball; Iole Brunetti; Antoni Torres Martí; Patricia Rieken Macedo Rocco; Paolo Pelosi Journal: Front Med (Lausanne) Date: 2021-06-04
Authors: Gianluigi Li Bassi; Raquel Guillamat Prats; Antonio Artigas; Eli Aguilera Xiol; Joan-Daniel Marti; Otavio T Ranzani; Montserrat Rigol; Laia Fernandez; Andrea Meli; Denise Battaglini; Nestor Luque; Miguel Ferrer; Ignacio Martin-Loeches; Pedro Póvoa; Davide Chiumello; Paolo Pelosi; Antoni Torres Journal: Intensive Care Med Exp Date: 2018-10-20