Top

Published in:

01-11-2017 | Original

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

Authors: Gianluigi Li Bassi, Mauro Panigada, Otavio T. Ranzani, Alberto Zanella, Lorenzo Berra, Massimo Cressoni, Vieri Parrini, Hassan Kandil, Giovanni Salati, Paola Selvaggi, Alessandro Amatu, Miquel Sanz-Moncosi, Emanuela Biagioni, Fernanda Tagliaferri, Mirella Furia, Giovanna Mercurio, Antonietta Costa, Tullio Manca, Simone Lindau, Jaksa Babel, Marco Cavana, Chiara Chiurazzi, Joan-Daniel Marti, Dario Consonni, Luciano Gattinoni, Antonio Pesenti, Janine Wiener-Kronish, Cecilia Bruschi, Andrea Ballotta, Pierpaolo Salsi, Sergio Livigni, Giorgio Iotti, Javier Fernandez, Massimo Girardis, Maria Barbagallo, Gabriella Moise, Massimo Antonelli, Maria Luisa Caspani, Antonella Vezzani, Patrick Meybohm, Vladimir Gasparovic, Edoardo Geat, Marcelo Amato, Michael Niederman, Theodor Kolobow, Antoni Torres, for the Gravity-VAP Network

Published in: Intensive Care Medicine | Issue 11/2017

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.

Available only for authorised users

Wang Y, Eldridge N, Metersky ML, Verzier NR, Meehan TP, Pandolfi MM, Foody JM, Ho SY, Galusha D, Kliman RE, Sonnenfeld N, Krumholz HM, Battles J (2014) National trends in patient safety for four common conditions, 2005-2011. N Engl J Med 370:341–351. doi:10.1056/NEJMsa1300991 CrossRefPubMedPubMedCentral

Warren DK, Shukla SJ, Olsen MA, Kollef MH, Hollenbeak CS, Cox MJ, Cohen MM, Fraser VJ (2003) Outcome and attributable cost of ventilator-associated pneumonia among intensive care unit patients in a suburban medical center. Crit Care Med 31:1312–1317. doi:10.1097/01.CCM.0000063087.93157.06 CrossRefPubMed

Metersky ML, Wang Y, Klompas M, Eckenrode S, Bakullari A, Eldridge N (2016) Trend in ventilator-associated pneumonia rates between 2005 and 2013. JAMA 316:2427–2429. doi:10.1001/jama.2016.16226 CrossRefPubMed

Dudeck MA, Edwards JR, Allen-Bridson K, Gross C, Malpiedi PJ, Peterson KD, Pollock DA, Weiner LM, Sievert DM (2015) National Healthcare Safety Network (NHSN) report, data summary for 2013, device-associated module. Am J Infect Control 43:206–221. doi:10.1016/j.ajic.2014.11.014 CrossRefPubMed

Rosenthal VD, Al-Abdely HM, El-Kholy AA, AlKhawaja SA, Leblebicioglu H, Mehta Y, Rai V, Hung NV, Kanj SS, Salama MF, Salgado-Yepez E, Elahi N, Morfin Otero R, Apisarnthanarak A, De Carvalho BM, Ider BE, Fisher D, Buenaflor MC, Petrov MM, Quesada-Mora AM, Zand F, Gurskis V, Anguseva T, Ikram A, Aguilar de Moros D, Duszynska W, Mejia N, Horhat FG, Belskiy V, Mioljevic V, Di Silvestre G, Furova K, Ramos-Ortiz GY, Gamar Elanbya MO, Satari HI, Gupta U, Dendane T, Raka L, Guanche-Garcell H, Hu B, Padgett D, Jayatilleke K, Ben Jaballah N, Apostolopoulou E, Prudencio Leon WE, Sepulveda-Chavez A, Telechea HM, Trotter A, Alvarez-Moreno C, Kushner-Davalos L (2016) International Nosocomial Infection Control Consortium report, data summary of 50 countries for 2010-2015: device-associated module. Am J Infect Control 44:1495–1504. doi:10.1016/j.ajic.2016.08.007 CrossRefPubMed

Torres A, El-Ebiary M, Soler N, Montón C, Fàbregas N, Hernández C (1996) Stomach as a source of colonization of the respiratory tract during mechanical ventilation: association with ventilator-associated pneumonia. Eur Respir J 9:1729–1735CrossRefPubMed

Krag M, Perner A, Wetterslev J, Wise MP, Hylander Møller M (2014) Stress ulcer prophylaxis versus placebo or no prophylaxis in critically ill patients. A systematic review of randomised clinical trials with meta-analysis and trial sequential analysis. Intensive Care Med 40:11–22CrossRefPubMed

Torres A, Serra-Batlles J, Ros E, Piera C, Puig de la Bellacasa J, Cobos A, Lomeña F, Rodríguez-Roisin R (1992) Pulmonary aspiration of gastric contents in patients receiving mechanical ventilation: the effect of body position. Ann Intern Med 116:540–543CrossRefPubMed

Torres A, el-Ebiary M, González J, Ferrer M, Puig de la Bellacasa J, Gené A, Martos A, Rodriguez-Roisin R (1993) Gastric and pharyngeal flora in nosocomial pneumonia acquired during mechanical ventilation. Am Rev Respir Dis 148:352–357CrossRefPubMed

10.

Nseir S, Zerimech F, Fournier C, Lubret R, Ramon P, Durocher A, Balduyck M (2011) Continuous control of tracheal cuff pressure and microaspiration of gastric contents in critically ill patients. Am J Respir Crit Care Med 184:1041–1047. doi:10.1164/rccm.201104-0630OC CrossRefPubMed

11.

Philippart F, Gaudry S, Quinquis L, Lau N, Ouanes I, Touati S, Nguyen JC, Branger C, Faibis F, Mastouri M, Forceville X, Abroug F, Ricard JD, Grabar S, Misset B, TOP-Cuff Study Group (2015) Randomized intubation with polyurethane or conical cuffs to prevent pneumonia in ventilated patients. Am J Respir Crit Care Med 191:637–645. doi:10.1164/rccm.201408-1398OC CrossRefPubMed

12.

Branch-Elliman W, Wright SB, Howell MD (2015) Determining the ideal strategy for ventilator-associated pneumonia prevention: cost-benefit analysis. Am J Respir Crit Care Med 192:57–63. doi:10.1164/rccm.201412-2316OC CrossRefPubMed

13.

Orozco-Levi M, Torres A, Ferrer M, Piera C, el-Ebiary M, de la Bellacasa JP, Rodriguez-Roisin R (1995) Semirecumbent position protects from pulmonary aspiration but not completely from gastroesophageal reflux in mechanically ventilated patients. Am J Respir Crit Care Med 152:1387–1390CrossRefPubMed

14.

Drakulovic MB, Torres A, Bauer TT, Nicolas JM, Nogué S, Ferrer M (1999) Supine body position as a risk factor for nosocomial pneumonia in mechanically ventilated patients: a randomised trial. Lancet 354:1851–1858. doi:10.1016/S0140-6736(98)12251-1 CrossRefPubMed

15.

Wang L, Li X, Yang Z, Tang X, Yuan Q, Deng L, Sun X (2016) Semi-recumbent position versus supine position for the prevention of ventilator-associated pneumonia in adults requiring mechanical ventilation. Cochrane Database Syst Rev. doi:10.1002/14651858.CD009946.pub2

16.

van Nieuwenhoven CA, Vandenbroucke-Grauls C, van Tiel FH, Joore HC, van Schijndel RJ, van der Tweel I, Ramsay G, Bonten MJ (2006) Feasibility and effects of the semirecumbent position to prevent ventilator-associated pneumonia: a randomized study. Crit Care Med 34:396–402. doi:10.1097/01.CCM.0000198529.76602.5E CrossRefPubMed

17.

Li Bassi G, Marti JD, Saucedo L, Rigol M, Roca I, Cabanas M, Muñoz L, Ranzani OT, Giunta V, Luque N, Esperatti M, Gabarrus A, Fernandez L, Rinaudo M, Ferrer M, Ramirez J, Vila J, Torres A (2014) Gravity predominates over ventilatory pattern in the prevention of ventilator-associated pneumonia. Crit Care Med 42:e620–e627. doi:10.1097/CCM.0000000000000487 CrossRefPubMed

18.

Li Bassi G, Zanella A, Cressoni M, Stylianou M, Kolobow T (2008) Following tracheal intubation, mucus flow is reversed in the semirecumbent position: possible role in the pathogenesis of ventilator-associated pneumonia. Crit Care Med 36:518–525. doi:10.1097/01.CCM.0000299741.32078.E9 CrossRefPubMed

19.

Panigada M, Berra L, Greco G, Stylianou M, Kolobow T (2003) Bacterial colonization of the respiratory tract following tracheal intubation-effect of gravity: an experimental study. Crit Care Med 31:729–737. doi:10.1097/01.CCM.0000049943.01252.E5 CrossRefPubMed

20.

Zanella A, Cressoni M, Epp M, Hoffmann V, Stylianou M, Kolobow T (2012) Effects of tracheal orientation on development of ventilator-associated pneumonia: an experimental study. Intensive Care Med 38:677–685. doi:10.1007/s00134-012-2495-2 CrossRefPubMed

21.

Mauri T, Berra L, Kumwilaisak K, Pivi S, Ufberg JW, Kueppers F, Pesenti A, Bigatello LM (2010) Lateral-horizontal patient position and horizontal orientation of the endotracheal tube to prevent aspiration in adult surgical intensive care unit patients: a feasibility study. Respir Care 55:294–302PubMed

22.

Aly H, Badawy M, El-Kholy A, Nabil R, Mohamed A (2008) Randomized, controlled trial on tracheal colonization of ventilated infants: can gravity prevent ventilator-associated pneumonia? Pediatrics 122:770–774. doi:10.1542/peds.2007-1826 CrossRefPubMed

23.

Kalil AC, Metersky ML, Klompas M, Muscedere J, Sweeney DA, Palmer LB, Napolitano LM, O’Grady NP, Bartlett JG, Carratalà J, El Solh AA, Ewig S, Fey PD, File TM Jr, Restrepo MI, Roberts JA, Waterer GW, Cruse P, Knight SL, Brozek JL (2016) Management of adults with hospital-acquired and ventilator-associated pneumonia: 2016 clinical practice guidelines by the Infectious Diseases Society of America and the American Thoracic Society. Clin Infect Dis 63:e61–e111. doi:10.1093/cid/ciw353 CrossRefPubMedPubMedCentral

24.

de Jong E, van Oers JA, Beishuizen A, Vos P, Vermeijden WJ, Haas LE, Loef BG, Dormans T, van Melsen GC, Kluiters YC, Kemperman H, van den Elsen MJ, Schouten JA, Streefkerk JO, Krabbe HG, Kieft H, Kluge GH, van Dam VC, van Pelt J, Bormans L, Otten MB, Reidinga AC, Endeman H, Twisk JW, van de Garde EM, de Smet AM, Kesecioglu J, Girbes AR, Nijsten MW, de Lange DW (2016) Efficacy and safety of procalcitonin guidance in reducing the duration of antibiotic treatment in critically ill patients: a randomised, controlled, open-label trial. Lancet Infect Dis 16:819–827. doi:10.1016/S1473-3099(16)00053-0 CrossRefPubMed

25.

Schweickert WD, Gehlbach BK, Pohlman AS, Hall JB, Kress JP (2004) Daily interruption of sedative infusions and complications of critical illness in mechanically ventilated patients. Crit Care Med 32:1272–1276. doi:10.1097/01.CCM.0000127263.54807.79 CrossRefPubMed

26.

Schulz KF, Altman DG, Moher D, CONSORT Group (2010) CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med 152:726–732. doi:10.7326/0003-4819-152-11-201006010-00232 CrossRefPubMed

27.

Wolkewitz M, Cooper BS, Bonten MJ, Barnett AG, Schumacher M (2014) Interpreting and comparing risks in the presence of competing events. BMJ 349:g5060. doi:10.1136/bmj.g5060 CrossRefPubMed

28.

Young P, Saxena M, Bellomo R, Freebairn R, Hammond N, van Haren F, Holliday M, Henderson S, Mackle D, McArthur C, McGuinness S, Myburgh J, Weatherall M, Webb S, Beasley R, HEAT Investigators; Australian and New Zealand Intensive Care Society Clinical Trials Group (2015) Acetaminophen for fever in critically ill patients with suspected infection. N Engl J Med 373:2215–2224. doi:10.1056/NEJMoa1508375 CrossRefPubMed

29.

Angrist JD, Imbens GW, Rubin DB (1996) Identification of causal effects using instrumental variables. J Am Stat Assoc 91:444–455CrossRef

30.

Kollef MH, Afessa B, Anzueto A, Veremakis C, Kerr KM, Margolis BD, Craven DE, Roberts PR, Arroliga AC, Hubmayr RD, Restrepo MI, Auger WR, Schinner R, NASCENT Investigation Group (2008) Silver-coated endotracheal tubes and incidence of ventilator-associated pneumonia: the NASCENT randomized trial. JAMA 300:805–813. doi:10.1001/jama.300.7.805 CrossRefPubMed

31.

Rello J, Ollendorf DA, Oster G, Vera-Llonch M, Bellm L, Redman R, Kollef M (2002) Epidemiology and outcomes of ventilator-associated pneumonia in a large US database. Chest 122:2115–2121. doi:10.1378/chest.122.6.2115 CrossRefPubMed

32.

Cook DJ, Walter SD, Cook RJ, Griffith LE, Guyatt GH, Leasa D, Jaeschke RZ, Brun-Buisson C (1998) Incidence of and risk factors for ventilator-associated pneumonia in critically ill patients. Ann Intern Med 129:433–440. doi:10.7326/0003-4819-129-6-199809150-00002 CrossRefPubMed

33.

Marini JJ, Gattinoni L (2008) Propagation prevention: a complementary mechanism for “lung protective” ventilation in acute respiratory distress syndrome. Crit Care Med 36:3252–3258. doi:10.1097/CCM.0b013e31818f0e68 CrossRefPubMed

34.

Simonis G, Flemming K, Ziegs E, Haacke K, Rauwolf T, Strasser RH (2007) Kinetic therapy reduces complications and shortens hospital stay in patients with cardiogenic shock - a retrospective analysis. Eur J Cardiovasc Nurs 6:40–45. doi:10.1016/j.ejcnurse.2006.03.008 CrossRefPubMed

35.

Goldhill DR, Badacsonyi A, Goldhill AA, Waldmann C (2008) A prospective observational study of ICU patient position and frequency of turning. Anaesthesia 63:509–515. doi:10.1111/j.1365-2044.2007.05431.x CrossRefPubMed

36.

Ayzac L, Girard R, Baboi L, Beuret P, Rabilloud M, Richard JC, Guérin C (2015) Ventilator-associated pneumonia in ARDS patients: the impact of prone positioning. A secondary analysis of the PROSEVA trial. Intensive Care Med 42:871–878. doi:10.1007/s00134-015-4167-5 CrossRefPubMed

37.

Hernán MA, Hernández-Díaz S (2012) Beyond the intention-to-treat in comparative effectiveness research. Clin Trials 9:48–55. doi:10.1177/1740774511420743 CrossRefPubMed

Title: Randomized, multicenter trial of lateral Trendelenburg versus semirecumbent body position for the prevention of ventilator-associated pneumonia
Authors: Gianluigi Li Bassi
Mauro Panigada
Otavio T. Ranzani
Alberto Zanella
Lorenzo Berra
Massimo Cressoni
Vieri Parrini
Hassan Kandil
Giovanni Salati
Paola Selvaggi
Alessandro Amatu
Miquel Sanz-Moncosi
Emanuela Biagioni
Fernanda Tagliaferri
Mirella Furia
Giovanna Mercurio
Antonietta Costa
Tullio Manca
Simone Lindau
Jaksa Babel
Marco Cavana
Chiara Chiurazzi
Joan-Daniel Marti
Dario Consonni
Luciano Gattinoni
Antonio Pesenti
Janine Wiener-Kronish
Cecilia Bruschi
Andrea Ballotta
Pierpaolo Salsi
Sergio Livigni
Giorgio Iotti
Javier Fernandez
Massimo Girardis
Maria Barbagallo
Gabriella Moise
Massimo Antonelli
Maria Luisa Caspani
Antonella Vezzani
Patrick Meybohm
Vladimir Gasparovic
Edoardo Geat
Marcelo Amato
Michael Niederman
Theodor Kolobow
Antoni Torres
for the Gravity-VAP Network
Publication date: 01-11-2017
Publisher: Springer Berlin Heidelberg
Published in: Intensive Care Medicine / Issue 11/2017
Print ISSN: 0342-4642
Electronic ISSN: 1432-1238
DOI: https://doi.org/10.1007/s00134-017-4858-1

At a glance: The STEP trials

Springer Medicine

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

Abstract

Purpose

Methods

Results

Conclusions

ClinicalTrials.gov identifier

At a glance: The STEP trials

Springer Medicine

Abstract

Purpose

Methods

Results

Conclusions

ClinicalTrials.gov identifier

Please log in to get access to this content

Other articles of this Issue 11/2017

Effect of a multifaceted educational intervention for anti-infectious measures on sepsis mortality: a cluster randomized trial

Early application of airway pressure release ventilation may reduce the duration of mechanical ventilation in acute respiratory distress syndrome

Intensive Care Medicine in 2050: global perspectives

Core elements of general supportive care for patients with sepsis and septic shock in resource-limited settings

Beware the siren’s song of novel endotracheal tube designs

Therapeutic targets in necrotizing soft tissue infections