Intraoperative RMs Clinical Trial
Official title:
Intraoperative Lung Protective Ventilation in Abdominal Surgery: A Randomized Controlled Study
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment