The purpose of this study is to compare the influence of a lung protective ventilation with conventional ventilation on postoperative complications following major abdominal surgery.
Postoperative complications are associated with a significant and quantifiable rate of both morbidity and mortality, increased length of hospital stay and cost of care. Intra-abdominal surgery, especially upper abdominal surgery, is an important risk factor of both pulmonary and extra-pulmonary complications. Up to 15-20% of patients will develop postoperative respiratory failure which may require respiratory support. Recent data from both experimental and clinical studies suggested that, compared with conventional ventilation using high tidal volume (TV) without positive end-expiratory pressure (PEEP), intraoperative lung protective ventilation using low tidal volume, PEEP and recruitment maneuvers (RM) could reduce postoperative complications. Conventional ventilation promotes sustained cytokine production and could therefore contribute to development of lung injury with in patients with normal lungs. Conversely, lung protective ventilation was found to reduce pulmonary and systemic inflammation. The primary objective is to compare a lung protective ventilation with conventional ventilation (high tidal volumes without PEEP) during abdominal surgery: 1- Conventional ventilation with TV of 10-12 mL/kg predicted body weight (PBW) without PEEP; 2- Protective lung ventilation with TV of 6-8 mL/kg PBW, PEEP of 6-8 cmH2O and RM. Our hypothesis is that lung protective ventilation could reduce postoperative pulmonary and extra-pulmonary complications compared with conventional ventilation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
400
to compare the influence of a lung protective ventilation with conventional ventilation on postoperative complications following major abdominal surgery
Chu Clermont-Ferrand
Clermont-Ferrand, France
Composite endpoint defined as incidence of major postoperative pulmonary (defined as pneumonia, need for noninvasive ventilation or need for invasive ventilation) and extrapulmonary (SIRS, sepsis and septic shock) complications
Time frame: during the first seven days after surgery
Major complications: postoperative hypoxemia, postoperative pneumonia, acute lung injury (ALI), acute respiratory distress syndrome (ARDS), pulmonary embolism
Time frame: at day 15 after surgery
Minor complications : atelectasis, anastomotic leakage, intrabdominal abscess
Time frame: at day 15 after surgery
Other postoperative complications (reintervention, wound abscess, ...)
Time frame: at day 15 after surgery
Systemic level of marker of inflammation (C Reactive protein)
Time frame: at day 15 after surgery
Postoperative complications at day 30 after surgery
Time frame: at day 30 after surgery
Need for ICU admission
Time frame: at day 30 after surgery
ICU length of stay
Time frame: at day 30 after surgery
Hospital length of stay
Time frame: at day 30 after surgery
Mortality
Time frame: at day 30 after surgery
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Plasma levels of the soluble form of the receptor for advanced glycation end-products (sRAGE), a marker of alveolar type I cell injury
Time frame: before surgery, during the immediate postoperative period and on day 1, day 3 and day 7 after surgery