Reduction of surgical wound infection breathing high concentrations of oxygen during anesthesia

Effects on surgical site infection of an individualized perioperative openlung ventilatory strategy with high versus conventional inspiratory oxygen fraction (iPROVEO2). A comparative, prospective, multicenter, randomized controlled trial. - iPROVE-O2

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002936-34-ES

Enrollment

756

Registered

2016-11-17

Start date

2017-01-30

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The study population will be patients who are scheduled for major abdominal (laparotomy and laparoscopic) surgery under general anaesthesia.

Interventions

Trade Name: Oxígeno Medicinal Líquido Gasmedi 99,5% gas criogénico medicinal Pharmaceutical Form: Medicinal gas, liquefied INN or Proposed INN: OXYGEN C

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Male or female patients =18 years old, 2) Body mass index (BMI) of =65 years) yes F.1.3.1 Number of subjects for this age range 300

Exclusion criteria

Exclusion criteria: 1) 35 Kg/m2 4) Moderate or severe acute respiratory distress syndrome (ARDS; PaO2/ FIO2 2.5 when = 5µg/kg/min dobutamine is required, or suspected heart failure according to clinical signs (hypotension, oliguria, pulmonary edema) together with NT-proBNP > 13pg/ml, 6) Suspected intracranial hypertension (> 15 mmHg) 7) Presence of pneumothorax or giant bullae on a chest radiograph or computed tomography (CT) 8) Patients participating in another interventional study.

Design outcomes

Primary

Measure	Time frame
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; 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. ;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.;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.	—

Measure

Time frame

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; 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. ;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.;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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Spain

Contacts

Public ContactMarina Soro Domingo

Marina Soro Domingo

soromarina@gmail.com0034961973847

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026