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Trials
Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

Different strategies for mechanical VENTilation during CardioPulmonary Bypass (CPBVENT 2014): study protocol for a randomized controlled trial

Authors: Elena Bignami, Marcello Guarnieri, Francesco Saglietti, Enivarco Massimo Maglioni, Sabino Scolletta, Stefano Romagnoli, Stefano De Paulis, Gianluca Paternoster, Cinzia Trumello, Roberta Meroni, Antonio Scognamiglio, Alessandro Maria Budillon, Vincenzo Pota, Alberto Zangrillo, Ottavio Alfieri

Published in: Trials | Issue 1/2017

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Abstract

Background

There is no consensus on which lung-protective strategies should be used in cardiac surgery patients. Sparse and small randomized clinical and animal trials suggest that maintaining mechanical ventilation during cardiopulmonary bypass is protective on the lungs. Unfortunately, such evidence is weak as it comes from surrogate and minor clinical endpoints mainly limited to elective coronary surgery. According to the available data in the academic literature, an unquestionable standardized strategy of lung protection during cardiopulmonary bypass cannot be recommended. The purpose of the CPBVENT study is to investigate the effectiveness of different strategies of mechanical ventilation during cardiopulmonary bypass on postoperative pulmonary function and complications.

Methods/design

The CPBVENT study is a single-blind, multicenter, randomized controlled trial. We are going to enroll 870 patients undergoing elective cardiac surgery with planned use of cardiopulmonary bypass. Patients will be randomized into three groups: (1) no mechanical ventilation during cardiopulmonary bypass, (2) continuous positive airway pressure of 5 cmH2O during cardiopulmonary bypass, (3) respiratory rate of 5 acts/min with a tidal volume of 2–3 ml/Kg of ideal body weight and positive end-expiratory pressure of 3–5 cmH2O during cardiopulmonary bypass. The primary endpoint will be the incidence of a PaO2/FiO2 ratio <200 until the time of discharge from the intensive care unit. The secondary endpoints will be the incidence of postoperative pulmonary complications and 30-day mortality. Patients will be followed-up for 12 months after the date of randomization.

Discussion

The CPBVENT trial will establish whether, and how, different ventilator strategies during cardiopulmonary bypass will have an impact on postoperative pulmonary complications and outcomes of patients undergoing cardiac surgery.

Trial registration

ClinicalTrials.gov, ID: NCT02090205. Registered on 8 March 2014.
Appendix
Available only for authorised users
Literature
1.
Ball L, Costantino F, Pelosi P. Postoperative complications of patients undergoing cardiac surgery. Curr Opin Crit Care. 2016;22(4):386–92.CrossRefPubMed
2.
Magnusson L, Zemgulis V, Wicky S, Tydén H, Thelin S, Hedenstierna G. Atelectasis is a major cause of hypoxemia and shunt after cardiopulmonary bypass: an experimental study. Anesthesiology. 1997;87:1153–63.CrossRefPubMed
3.
Reber A, Budmiger B, Wenk M, Haefeli WE, Wolff T, Bein T, et al. Inspired oxygen fraction after cardiopulmonary bypass: effects on pulmonary function with regard to endothelin-1 concentrations and venous admixture. Br J Anaesth. 2000;84:565–70.CrossRefPubMed
4.
Laffey JG, Boylan JF, Cheng DC. The systemic inflammatory response to cardiac surgery: implications for the anesthesiologist. Anesthesiology. 2002;97:215–52.CrossRefPubMed
5.
Allou N, Bronchard R, Guglielminotti J, Dilly MP, Provenchere S, Lucet JC, et al. Risk factors for postoperative pneumonia after cardiac surgery and development of a preoperative risk score. Crit Care Med. 2014;42:1150–6.CrossRefPubMed
6.
Apostolakis EE, Koletsis EN, Baikoussis NG, Siminelakis SN, Papadopoulos GS. Strategies to prevent intraoperative lung injury during cardiopulmonary bypass. J Cardiothorac Surg. 2010;5:1.CrossRefPubMedPubMedCentral
7.
García-Delgado M, Navarrete-Sánchez I, Colmenero M. Preventing and managing perioperative pulmonary complications following cardiac surgery. Curr Opin Anaesthesiol. 2014;27:146–52.CrossRefPubMed
8.
Warren O, Alexiou C, Massey R, Leff D, Purkayastha S, Kinross J, et al. The effects of various leukocyte filtration strategies in cardiac surgery. Eur J Cardiothorac Surg. 2007;31:665–76.CrossRefPubMed
9.
Tassani P, Richter JA, Barankay A, Braun SL, Haehnel C, Spaeth P, et al. Does high-dose methylprednisolone in aprotinin-treated patients attenuate the systemic inflammatory response during coronary artery bypass grafting procedures? J Cardiothorac Vasc Anesth. 1999;13:165–72.CrossRefPubMed
10.
Vohra HA, Levine A, Dunning J. Can ventilation while on cardiopulmonary bypass improve post-operative lung function for patients undergoing cardiac surgery? Interact Cardiovasc Thorac Surg. 2005;4:442–6.CrossRefPubMed
11.
Schreiber JU, Lancé MD, de Korte M, Artmann T, Aleksic I, Kranke P. The effect of different lung-protective strategies in patients during cardiopulmonary bypass: a meta-analysis and semiquantitative review of randomized trials. J Cardiothorac Vasc Anesth. 2012;26:448–54. 4.CrossRefPubMed
12.
Loeckinger A, Kleinsasser A, Lindner KH, Margreiter J, Keller C, Hoermann C. Continuous positive airway pressure at 10 cm H(2)O during cardiopulmonary bypass improves postoperative gas exchange. Anesth Analg. 2000;91:522–7.CrossRefPubMed
13.
Oczenski W, Schwarz S, Fitzgerald RD. Vital capacity manoeuvre in general anaesthesia: useful or useless? Eur J Anaesthesiol. 2004;21:253–9.CrossRefPubMed
14.
Imura H, Caputo M, Lim K, Ochi M, Suleiman MS, Shimizu K, et al. Pulmonary injury after cardiopulmonary bypass: beneficial effects of low-frequency mechanical ventilation. J Thorac Cardiovasc Surg. 2009;137:1530–7.CrossRefPubMed
15.
Ng CS, Arifi AA, Wan S, Ho AM, Wan IY, Wong EM, et al. Ventilation during cardiopulmonary bypass: impact on cytokine response and cardiopulmonary function. Ann Thorac Surg. 2008;85:154–62.CrossRefPubMed
16.
Zupancich E, Paparella D, Turani F, Munch C, Rossi A, Massaccesi S, et al. Mechanical ventilation affects inflammatory mediators in patients undergoing cardiopulmonary bypass for cardiac surgery: a randomized clinical trial. J Thorac Cardiovasc Surg. 2005;130:378–83.CrossRefPubMed
17.
Celebi S, Köner O, Menda F, Korkut K, Suzer K, Cakar N. The pulmonary and hemodynamic effects of two different recruitment maneuvers after cardiac surgery. Anesth Analg. 2007;104:384–90.CrossRefPubMed
18.
Celebi S, Köner O, Menda F, Omay O, Günay I, Suzer K, et al. Pulmonary effects of noninvasive ventilation combined with the recruitment maneuver after cardiac surgery. Anesth Analg. 2008;107:614–9.CrossRefPubMed
19.
Dobbinson TL, Miller JR. Respiratory and cardiovascular responses to PEEP in artificially ventilated patients after cardiopulmonary bypass surgery. Anaesth Intensive Care. 1981;9:307–13.PubMed
20.
21.
Ferrando C, Soro M, Belda FJ. Protection strategies during cardiopulmonary bypass: ventilation, anesthetics and oxygen. Curr Opin Anaesthesiol. 2015;28:73–80.CrossRefPubMed
22.
Badenes R, Lozano A, Belda FJ. Postoperative pulmonary dysfunction and mechanical ventilation in cardiac surgery. Crit Care Res Pract. 2015;2015:420513.PubMedPubMedCentral
23.
Lellouche F, Delorme M, Bussières J, Ouattara A. Perioperative ventilatory strategies in cardiac surgery. Best Pract Res Clin Anaesthesiol. 2015;29(3):381–95.CrossRefPubMed
24.
Fischer MO, Courteille B, Guinot PG, Dupont H, Gérard JL, Hanouz JL, et al. Perioperative ventilatory management in cardiac surgery: a French nationwide survey. Medicine (Baltimore). 2016;95(9):e2655.CrossRef
25.
Definition Task Force ARDS, Ranieri VM, Rubenfeld GD, et al. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012;307:2526–33.
26.
Ranucci M, Ballotta A, La Rovere MT, Castelvecchio S, Surgical and Clinical Outcome Research (SCORE) Group. Postoperative hypoxia and length of intensive care unit stay after cardiac surgery: the underweight paradox? PLoS One. 2014;9(4):e93992.CrossRefPubMedPubMedCentral
27.
Hemmes SN, Gama de Abreu M, Pelosi P, Schultz MJ. High versus low positive end-expiratory pressure during general anaesthesia for open abdominal surgery (PROVHILO trial): a multicentre randomised controlled trial. Lancet. 2014;384(9942):495–503.CrossRefPubMed
28.
Weiss YG, Merin G, Koganov E, Ribo A, Oppenheim-Eden A, Medalion B, et al. Postcardiopulmonary bypass hypoxemia: a prospective study on incidence, risk factors, and clinical significance. J Cardiothorac Vasc Anesth. 2000;14(5):506–13.CrossRefPubMed
29.
Esteve F, Lopez-Delgado JC, Javierre C, Skaltsa K, Carrio ML, Rodríguez-Castro D, et al. Evaluation of the PaO2/FiO2 ratio after cardiac surgery as a predictor of outcome during hospital stay. BMC Anesthesiol. 2014;14:83.CrossRefPubMedPubMedCentral
30.
Futier E, Constantin JM, Paugam-Burtz C, Pascal J, Eurin M, Neuschwander A, et al. A trial of intraoperative low-tidal-volume ventilation in abdominal surgery. N Engl J Med. 2013;369:428–37.CrossRefPubMed
31.
Lellouche F, Dionne S, Simard S, Bussières J, Dagenais F. High tidal volumes in mechanically ventilated patients increase organ dysfunction after cardiac surgery. Anesthesiology. 2012;116:1072–82.CrossRefPubMed
32.
Ladha K, Vidal Melo MF, McLean DJ, Wanderer JP, Grabitz SD, Kurth T, et al. Intraoperative protective mechanical ventilation and risk of postoperative respiratory complications: hospital based registry study. BMJ. 2015;351:h3646.CrossRefPubMedPubMedCentral
33.
Young RW. Hyperoxia: a review of the risks and benefits in adult cardiac surgery. J Extra Corpor Technol. 2012;44:241–9.PubMedPubMedCentral
34.
Ranucci M, Castelvecchio S, Ditta A, Brozzi S, Boncilli A, Baryshnikova E. Transfusions during cardiopulmonary bypass: better when triggered by venous oxygen saturation and oxygen extraction rate. Perfusion. 2011;26:327–33.CrossRefPubMed
35.
Puls A, Pollok-Kopp B, Wrigge H, Quintel M, Neumann P. Effects of a single-lung recruitment maneuver on the systemic release of inflammatory mediators. Intensive Care Med. 2006;32:1080–5.CrossRefPubMed
36.
Pizov R, Weiss YG, Oppenheim-Eden A, Glickman H, Goodman S, Koganov Y, et al. High oxygen concentration exacerbates cardiopulmonary bypass-induced lung injury. J Cardiothorac Vasc Anesth. 2000;14(5):519–23.CrossRefPubMed
37.
Ranucci M, Castelvecchio S, Conte M, Megliola G, Speziale G, Fiore F, et al. The easier, the better: age, creatinine, ejection fraction score for operative mortality risk stratification in a series of 29,659 patients undergoing elective cardiac surgery. J Thorac Cardiovasc Surg. 2011;142:581–6.CrossRefPubMed
38.
Canet J, Gallart L, Gomar C, Paluzie G, Vallès J, Castillo J, et al. Prediction of postoperative pulmonary complications in a population-based surgical cohort. Anesthesiology. 2010;113:1338–50.CrossRefPubMed
39.
De Angelis C, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. N Engl J Med. 2004;351:1250–1.CrossRefPubMed
40.
International Conference on Harmonization. ICH Harmonized Tripartite Guideline. Good Clinical Practice. 1996.
41.
World Medical Association. Declaration of Helsinki. Ethical Principles for Medical Research Involving Human Subjects. 52nd WMA General Assembly, Edinburgh, Scotland, October 2000. Last Amended October 2008.
42.
Apostolakis E, Filos KS, Koletsis E, Dougenis D. Lung dysfunction following cardiopulmonary bypass. J Card Surg. 2010;25:47–55.CrossRefPubMed
43.
Paparella D, Yau TM, Young E. Cardiopulmonary bypass induced inflammation: pathophysiology and treatment. An update. Eur J Cardiothorac Surg. 2002;21:232–44.CrossRefPubMed
44.
Müller H, Hügel W, Reifschneider HJ, Horpacsy G, Hannekum A, Dalichau H. Lysosomal enzyme activity influenced by various types of respiration during extracorporeal circulation. Thorac Cardiovasc Surg. 1989;37:65–71.CrossRefPubMed
45.
Gaudriot B, Uhel F, Gregoire M, Gacouin A, Biedermann S, Roisne A, et al. Immune dysfunction after cardiac surgery with cardiopulmonary bypass: beneficial effects of maintaining mechanical ventilation. Shock. 2015;44(3):228–33.CrossRefPubMed
46.
Bignami E, Guarnieri M, Saglietti F, Belletti A, Trumello C, Giambuzzi I, et al. Mechanical ventilation during cardiopulmonary bypass. J Cardiothorac Vasc Anesth. 2016;30(6):1668–75.CrossRefPubMed
47.
Ibañez J, Riera M, Amezaga R, Herrero J, Colomar A, Campillo-Artero C, et al. Long-term mortality after pneumonia in cardiac surgery patients: a propensity-matched analysis. J Intensive Care Med. 2016;31(1):34-40.
48.
He S, Chen B, Li W, Yan J, Chen L, Wang X, et al. Ventilator-associated pneumonia after cardiac surgery: a meta-analysis and systematic review. J Thorac Cardiovasc Surg. 2014;148:3148–55. e1-5.CrossRefPubMed
49.
Beer L, Szerafin T, Mitterbauer A, Debreceni T, Maros T, Dworschak M, et al. Low tidal volume ventilation during cardiopulmonary bypass reduces postoperative chemokine serum concentrations. Thorac Cardiovasc Surg. 2014;62:677–82.CrossRefPubMed
50.
Durukan AB, Gurbuz HA, Salman N, Unal EU, Ucar HI, Yorgancioglu CE. Ventilation during cardiopulmonary bypass did not attenuate inflammatory response or affect postoperative outcomes. Cardiovasc J Afr. 2013;24:224–30.CrossRefPubMedPubMedCentral
51.
Beer L, Szerafin T, Mitterbauer A, Kasiri MM, Debreceni T, Palotás L, et al. Ventilation during cardiopulmonary bypass: impact on heat shock protein release. J Cardiovasc Surg. 2014;55:849–56.
52.
Beer L, Szerafin T, Mitterbauer A, Debreceni T, Maros T, Dworschak M, et al. Continued mechanical ventilation during coronary artery bypass graft operation attenuates the systemic immune response. Eur J Cardiothorac Surg. 2013;44:282–7.CrossRefPubMed
53.
Gagnon J, Laporta D, Béïque F, Langlois Y, Morin JF. Clinical relevance of ventilation during cardiopulmonary bypass in the prevention of postoperative lung dysfunction. Perfusion. 2010;25:205–10.CrossRefPubMed
54.
Davoudi M, Farhanchi A, Moradi A, Bakhshaei MH, Safarpour G. The effect of low tidal volume ventilation during cardiopulmonary bypass on postoperative pulmonary function. J Tehran Heart Cent. 2010;5:128–31.PubMedPubMedCentral
55.
Scherer M, Dettmer S, Meininger D, Deschka H, Geyer G, Regulla C, et al. Alveolar recruitment strategy during cardiopulmonary bypass does not improve postoperative gas exchange and lung function. Cardiovasc Eng. 2009;9:1–5.CrossRefPubMed
56.
John LC, Ervine IM. A study assessing the potential benefit of continued ventilation during cardiopulmonary bypass. Interact Cardiovasc Thorac Surg. 2008;7:14–7.CrossRefPubMed
57.
Altmay E, Karaca P, Yurtseven N, Ozkul V, Aksoy T, Ozler A, et al. Continuous positive airway pressure does not improve lung function after cardiac surgery. Can J Anaesth. 2006;53:919–25.CrossRefPubMed
58.
Ayad AE, Hamed HF. Continuous positive airway pressure (CPAP) during cardiopulmonary bypass attenuates postoperative pulmonary dysfunction and complications. Egypt J Anaesth. 2003;19:345–51.
59.
Claxton BA, Morgan P, McKeague H, Mulpur A, Berridge J. Alveolar recruitment strategy improves arterial oxygenation after cardiopulmonary bypass. Anaesthesia. 2003;58:111–6.CrossRefPubMed
60.
Zabeeda D, Gefen R, Medalion B, Khazin V, Shachner A, Ezri T. The effect of high-frequency ventilation of the lungs on postbypass oxygenation: a comparison with other ventilation methods applied during cardiopulmonary bypass. J Cardiothorac Vasc Anesth. 2003;17:40–4.CrossRefPubMed
61.
Beer L, Warszawska JM, Schenk P, Debreceni T, Dworschak M, Roth GA, et al. Intraoperative ventilation strategy during cardiopulmonary bypass attenuates the release of matrix metalloproteinases and improves oxygenation. J Surg Res. 2015;195:294–302.CrossRefPubMed
62.
Figueiredo LC, Araújo S, Abdala RC, Abdala A, Guedes CA. CPAP at 10 cm H2O during cardiopulmonary bypass does not improve postoperative gas exchange. Rev Bras Cir Cardiovasc. 2008;23:209–15.CrossRefPubMed
63.
Macedo FI, Gologorsky E, Costa AC, Pham SM, Salerno TA. Beating heart surgery with pulmonary perfusion and ventilation during cardiopulmonary bypass: target organs’ perfusion without plegia. Semin Thorac Cardiovasc Surg. 2012;24:308–10.CrossRefPubMed
64.
Lim CH, Nam MJ, Lee JS, Kim HJ, Kim JY, Shin HW, et al. A meta-analysis of pulmonary function with pulsatile perfusion in cardiac surgery. Artif Organs. 2015;39(2):110–7.CrossRefPubMed
Metadata
Title
Different strategies for mechanical VENTilation during CardioPulmonary Bypass (CPBVENT 2014): study protocol for a randomized controlled trial
Authors
Elena Bignami
Marcello Guarnieri
Francesco Saglietti
Enivarco Massimo Maglioni
Sabino Scolletta
Stefano Romagnoli
Stefano De Paulis
Gianluca Paternoster
Cinzia Trumello
Roberta Meroni
Antonio Scognamiglio
Alessandro Maria Budillon
Vincenzo Pota
Alberto Zangrillo
Ottavio Alfieri
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-2008-2

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