PeRioperative OXygen fraction – effect on surgical site Infection and pulmonary complications after abdominal surgery. (The PROXI-study) - The PROXI-study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-001710-32-DK

Enrollment

1400

Registered

2006-06-21

Start date

2006-07-05

Completion date

Unknown

Last updated

2013-04-22

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

Conditions

Laparotomy

Interventions

Product Name: Oxygen Pharmaceutical Form: Inhalation gas

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age 18 years or older. Laparotomy, acute or elective. In case of gynaecological surgery only if malignancy is suspected (defined as risk of ovarian malignancy index >200 or a specimen with atypic or neoplastic cells). 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Surgery within 30 days before scheduled laparotomy (except surgery in local anaesthesia) Chemotherapy within 3 months Inability to give informed consent Inability to keep oxygen saturation above 90% without supplemental oxygen (measured preoperatively by pulseoximetry)

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the effect of perioperative oxygen fraction (FiO2 30% vs. 80%) on surgical site infection and pulmonary complications after abdominal surgery. Primary hypothesis of study: Use of 80% oxygen decreases the incidence of surgical site infection after abdominal surgery ;Secondary Objective: To investigate the effect of perioperative oxygen fraction (FiO2 30% vs. 80%) on pulmonary complications (atelectasis, pneumonia, respiratory insufficiency), second operation, mortality and length of stay in hospital and intensive care unit after abdominal surgery.;Primary end point(s): Surgical site infection	—

Measure

Time frame

Main Objective: To investigate the effect of perioperative oxygen fraction (FiO2 30% vs. 80%) on surgical site infection and pulmonary complications after abdominal surgery. Primary hypothesis of study: Use of 80% oxygen decreases the incidence of surgical site infection after abdominal surgery ;Secondary Objective: To investigate the effect of perioperative oxygen fraction (FiO2 30% vs. 80%) on pulmonary complications (atelectasis, pneumonia, respiratory insufficiency), second operation, mortality and length of stay in hospital and intensive care unit after abdominal surgery.;Primary end point(s): Surgical site infection

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Countries

Denmark

Outcome results

None listed

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