Chu Clermont-Ferrand
Clermont-Ferrand, 63003, France
NCT Number: NCT01282996
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.
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Notify Me40 year–90 year
All sexes
Interventional
Phase 4
Clermont-Ferrand, 63003, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
to compare the influence of a lung protective ventilation with conventional ventilation on postoperative complications following major abdominal surgery
Time frame: during the first seven days after surgery
Time frame: at day 15 after surgery
Time frame: at day 15 after surgery
Time frame: at day 15 after surgery
Time frame: at day 15 after surgery
Time frame: at day 30 after surgery
Time frame: at day 30 after surgery
Time frame: at day 30 after surgery
Time frame: at day 30 after surgery
Time frame: at day 30 after surgery
Time frame: before surgery, during the immediate postoperative period and on day 1, day 3 and day 7 after surgery
University Hospital, Clermont-Ferrand
Other
Intraoperative Lung Protective Ventilation in Abdominal Surgery: A Randomized Controlled Study
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