Effects on surgical site infection of an individualized perioperative openlung

INTERVENTION: Trade Name: Oxígeno Medicinal Líquido Gasmedi 99,5% gas criogénico medicinal Pharmaceutical Form: Medicinal gas, liquefied INN or Proposed INN: OXYGEN CAS Number: SUB14733MIG Current Sponsor code: O2 Other descriptive name: Medicinal Oxygen Concentration unit: % percent Concentration type: equal Concentration number: 80‐ Trade Name: Oxygen compressed Pharmaceutical Form: Medicinal gas, liquefied INN or Proposed INN: OXYGEN CAS Number: SUB14733MIG Current Sponsor code: O2 Other descriptive name: Medicinal Oxygen Concentration unit: % percent Concentration type: equal Concentration number: 30‐ CONDITION: The study population will be patients who are scheduled for major abdominal (laparotomy and laparoscopic) surgery under general anaesthesia. Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] ‐ Anesthesia and Analgesia [E03] PRIMARY OUTCOME: Main Objective: To compare the efficacy of high vs. conventional FIO2 (inspiratory oxygen fraction) within a perioperative individualized ventilatory strategy to reduce the overall incidence of surgical site infection during the first 7 days after surgery in patients scheduled for abdominal surgery Primary end point(s): The appearance of surgical site infection , using the criteria set out by the Center for Disease Control (CDC) in study subjects within the first 7 postoperative days. Secondary Objective: To evaluate the composite of systemic complications experienced by the subjects in the first 7 postoperative days:; 1) Anastomosis dehiscence; 2) Sepsis; 3) Septic shock; 4) Requirement for surgical re‐intervention; 5) PONV; 6) Urinary infection; 7) Postoperative cognitive dysfunction; 8) Paralytic ileus; 9) Heart failure; 10) Myocardial ischemia; 11) Cardiac arrhythmias; 12) Renal failure; ; To evaluate other secondary complications experienced by the subjects in the first 7 postoperative days:; 13) Pulmonary complications: 14) Increased ICU and hospital length of stay (LOS); 15) ICU and hospital readmission in the first 30 postsurgical days; 16) Mortality within 30. Timepoint(s) of evaluation of this end point: The primary end point will be taken 3 h after PACU/ICU admission and at 1, 2, 7, and 30 days after surgery. INCLUSION CRITERIA: 1) Male or female patients =18 years old, 2) Body mass index (BMI) of <35 kg/m2 3) Scheduled for major abdominal (laparotomy and laparoscopic) surgery with an expected surgery duration of more than 2h. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 456 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 300 SECONDARY OUTCOME: Secondary end point(s): The secondary end points are :; To evaluate the composite of systemic complications experienced by the subjects in the first 7 postoperative days:; 1) Anastomosis dehiscence; 2) Sepsis; 3) Septic shock; 4) Requirement for surgical re‐intervention; 5) PONV; 6) Urinary infection; 7) Postoperative cognitive dysfunction; 8) Paralytic ileus; 9) Heart failure; 10) Myocardial ischemia; 11) Cardiac arrhythmias; 12) Renal failure; ; Other secondary end points are: ; 13) Pulmonary complications: 14) Increased ICU and hospital length of stay (LOS); 15) ICU and hospital readmission in the first 30 postsurgical days; 16) Mortality within 30. Timepoint(s) of evaluation of this end point: The secondary end points will be taken 3 h after PACU/ICU admission and at 1, 2, 7, and 30 days after surgery, with a 180‐ and 365‐day follow‐up for mortality.