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Supplemental Oxygen and Complications After Abdominal Surgery (The PROXI-trial)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00364741
Recruitment Status : Completed
First Posted : August 16, 2006
Last Update Posted : October 16, 2009
Information provided by:

Study Description
Brief Summary:

Aim: To investigate the effect of high intra- and postoperative oxygen concentration (80%, as opposed to normally 30%) on surgical wound infection and pulmonary complications after abdominal surgery.

Background: Surgical wound infection is a common and serious complication. Tissue oxygen tension is often low after surgery and the resistance against infection depends on this factor through bacterial killing by neutrophils. Oxygen is a substrate in this reaction, and it is hypothesized that by increasing the arterial oxygen tension, the risk of surgical wound infection is reduced. Previous studies to test this hypothesis have shown entirely different results. Hence, the clinical decision between high and normal oxygen concentration is still controversial.

Primary hypothesis of study: Use of 80% oxygen decreases the incidence of surgical wound infection after abdominal surgery.

Secondary objectives: To investigate the effect 80% oxygen on pulmonary complications (atelectasis, pneumonia, respiratory insufficiency), second operation, mortality and length of postoperative hospitalization and admission to intensive care unit after abdominal surgery.

Condition or disease Intervention/treatment Phase
Laparotomy Drug: Oxygen Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: PeRioperative OXygen Fraction - Effect on Surgical Site Infection and Pulmonary Complications After Abdominal Surgery (The PROXI-trial)
Study Start Date : October 2006
Primary Completion Date : October 2008
Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: A
Fraction of inspired oxygen (FiO2) = 0.30
Drug: Oxygen
During and 2 hours after surgery
Active Comparator: B
FiO2 = 0.80
Drug: Oxygen
During and 2 hours after surgery

Outcome Measures

Primary Outcome Measures :
  1. Surgical wound infection [ Time Frame: 14 days after surgery ]

Secondary Outcome Measures :
  1. Atelectasis, pneumonia, respiratory insufficiency, second operation, mortality, length of postoperative hospitalization, admission to intensive care unit. [ Time Frame: 30 days after surgery ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 atypical or neoplastic cells).

Exclusion Criteria:

  • Other surgery within 30 days (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 pulse oximetry).
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00364741

Aarhus Sygehus
Aarhus, Denmark, DK-8000
Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark, DK-2100
Copenhagen University Hospital, Amager
Copenhagen, Denmark, DK-2300
Copenhagen University Hospital, Bispebjerg
Copenhagen, Denmark, DK-2400
Copenhagen University Hospital, Gentofte
Hellerup, Denmark, DK-2900
Copenhagen University Hospital, Herlev
Herlev, Denmark, DK-2730
Holbaek Hospital
Holbaek, Denmark, DK-4300
Kolding Hospital
Kolding, Denmark, DK-6000
Naestved Hospital
Naestved, Denmark, DK-4700
Nykoebing Falster Hospital
Nykoebing Falster, Denmark, DK-4800
Slagelse Hospital
Slagelse, Denmark, DK-4200
Funen County Hospital
Svendborg, Denmark, DK-5700
Vejle Hospital
Vejle, Denmark, DK-7100
Viborg Hospital
Viborg, Denmark, DK-8800
Sponsors and Collaborators
Rigshospitalet, Denmark
The Danish Medical Research Council
Study Chair: Lars S. Rasmussen, MD,DMSc,PHD Dept. of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark
Study Director: Jørn Wetterslev, MD, PHD Copenhagen Trial Unit, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark
Study Director: Lars N. Jørgensen, MD, DMSc Dept. of Surgery, Copenhagen University Hospital, Bispebjerg, Copenhagen, Denmark
Principal Investigator: Christian S. Meyhoff, MD, PhD Dept. of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark
More Information

Responsible Party: Lars S. Rasmussen, Department of Anaesthesia, HOC, Copenhagen University Hospital, Rigshospitalet
ClinicalTrials.gov Identifier: NCT00364741     History of Changes
Other Study ID Numbers: 2006-001710-32
KF 02 306766
First Posted: August 16, 2006    Key Record Dates
Last Update Posted: October 16, 2009
Last Verified: October 2009