Margaretha C van der Woude1, Laura Bormans, Robrecht P van der Horst, Meindert N Sosef, Henricus J Belgers, Sabrine N Hemmes, Anita Tuip-de Boer, Marcelo Gama de Abreu, Paolo Pelosi, Peter E Spronk, Ary Serpo Neto, Marcus J Schultz. 1. From the Department of Intensive Care Medicine (MCvdW, LB, RPvdH), Department of Anaesthesiology (MCvdW), Department of Pulmonology (RPvdH), Department of Surgery, Zuyderland Medical Centre, Heerlen (MNS, HJB), Department of Anaesthesiology (SNH), Laboratory of Experimental Intensive Care and Anaesthesiology (L·E·I·C·A), Amsterdam University Medical Centres, Location AMC, Amsterdam, The Netherlands (ATB, MJS), Department of Anaesthesiology and Intensive Care, Pulmonary Engineering Group, University Hospital Carl Gustav Carus, Dresden, Germany (MGdA), Department of Surgical Sciences and Integrated Diagnostics (PP), San Martino Policlinico Hospital, IRCCS for Oncology and Neurosciences, University of Genoa, Genoa, Italy (PP), Department of Intensive Care, Amsterdam University Medical Centres, Location AMC, Amsterdam (PES, ASN, MJS), Department of Intensive Care Medicine, Gelre Hospitals, Apeldoorn, The Netherlands (PES), Department of Critical Care Medicine, Hospital Israelita Albert Einstein (ASN), Pulmonary Division, Cardio-Pulmonary Department, Instituto do Coração, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil (ASN), Mahidol-Oxford Tropical Medicine Research Unit (MORU), Mahidol University, Bangkok, Thailand (MJS) and Nuffield Department of Medicine, University of Oxford, Oxford, UK (MJS).
Abstract
BACKGROUND: It is uncertain whether protective ventilation reduces ventilation-induced pulmonary inflammation and injury during one-lung ventilation. OBJECTIVE: To compare intra-operative protective ventilation with conventional during oesophagectomy with respect to pulmonary levels of biomarkers for inflammation and lung injury. DESIGN: Randomised clinical trial. SETTING:Tertiary centre for oesophageal diseases. PATIENTS: Twenty-nine patients scheduled for one-lung ventilation during oesophagectomy. INTERVENTIONS:Low tidal volume (VT) of 6 ml kg predicted body weight (pbw) during two-lung ventilation and 3 ml kgpbw during one-lung ventilation with 5 cmH2O positive end expired pressure versus intermediate VT of 10 ml kgpbw during two-lung ventilation and 5 ml kgpbw body weight during one-lung ventilation with no positive end-expiratory pressure. OUTCOME MEASURES: The primary outcome was the change in bronchoalveolar lavage (BAL) levels of preselected biomarkers for inflammation (TNF-α, IL-6 and IL-8) and lung injury (soluble Receptor for Advanced Glycation End-products, surfactant protein-D, Clara Cell protein 16 and Krebs von den Lungen 6), from start to end of ventilation. RESULTS: Median [IQR] VT in the protective ventilation group (n = 13) was 6.0 [5.7 to 7.8] and 3.1 [3.0 to 3.6] ml kgpbw during two and one-lung ventilation; VT in the conventional ventilation group (n = 16) was 9.8 [7.0 to 10.1] and 5.2 [5.0 to 5.5] ml kgpbw during two and one-lung ventilation. BAL levels of biomarkers for inflammation increased from start to end of ventilation in both groups; levels of soluble Receptor for Advanced Glycation End-products, Clara Cell protein 16 and Krebs von den Lungen 6 did not change, while levels of surfactant protein-D decreased. Changes in BAL biomarkers levels were not significantly different between the two ventilation strategies. CONCLUSION:Intra-operative protective ventilation compared with conventional ventilation does not affect changes in pulmonary levels of biomarkers for inflammation and lung injury in patients undergoing one-lung ventilation for oesophagectomy. TRIAL REGISTRATION: The 'Low versus Conventional tidal volumes during one-lung ventilation for minimally invasive oesophagectomy trial' (LoCo) was registered at the Netherlands Trial Register (study identifier NTR 4391).
RCT Entities:
BACKGROUND: It is uncertain whether protective ventilation reduces ventilation-induced pulmonary inflammation and injury during one-lung ventilation. OBJECTIVE: To compare intra-operative protective ventilation with conventional during oesophagectomy with respect to pulmonary levels of biomarkers for inflammation and lung injury. DESIGN: Randomised clinical trial. SETTING: Tertiary centre for oesophageal diseases. PATIENTS: Twenty-nine patients scheduled for one-lung ventilation during oesophagectomy. INTERVENTIONS: Low tidal volume (VT) of 6 ml kg predicted body weight (pbw) during two-lung ventilation and 3 ml kgpbw during one-lung ventilation with 5 cmH2O positive end expired pressure versus intermediate VT of 10 ml kgpbw during two-lung ventilation and 5 ml kgpbw body weight during one-lung ventilation with no positive end-expiratory pressure. OUTCOME MEASURES: The primary outcome was the change in bronchoalveolar lavage (BAL) levels of preselected biomarkers for inflammation (TNF-α, IL-6 and IL-8) and lung injury (soluble Receptor for Advanced Glycation End-products, surfactant protein-D, Clara Cell protein 16 and Krebs von den Lungen 6), from start to end of ventilation. RESULTS: Median [IQR] VT in the protective ventilation group (n = 13) was 6.0 [5.7 to 7.8] and 3.1 [3.0 to 3.6] ml kgpbw during two and one-lung ventilation; VT in the conventional ventilation group (n = 16) was 9.8 [7.0 to 10.1] and 5.2 [5.0 to 5.5] ml kgpbw during two and one-lung ventilation. BAL levels of biomarkers for inflammation increased from start to end of ventilation in both groups; levels of soluble Receptor for Advanced Glycation End-products, Clara Cell protein 16 and Krebs von den Lungen 6 did not change, while levels of surfactant protein-D decreased. Changes in BAL biomarkers levels were not significantly different between the two ventilation strategies. CONCLUSION: Intra-operative protective ventilation compared with conventional ventilation does not affect changes in pulmonary levels of biomarkers for inflammation and lung injury in patients undergoing one-lung ventilation for oesophagectomy. TRIAL REGISTRATION: The 'Low versus Conventional tidal volumes during one-lung ventilation for minimally invasive oesophagectomy trial' (LoCo) was registered at the Netherlands Trial Register (study identifier NTR 4391).