Clinical trial NCT00364741: Supplemental Oxygen and Complications After Abdominal Surgery (The PROXI-trial)
Official title: PeRioperative OXygen Fraction - Effect on Surgical Site Infection and Pulmonary Complications After Abdominal Surgery (The PROXI-trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Laparotomy
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: The Danish Medical Research Council
First posted: 2006-08-16
Enrollment: 1400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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 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).

Primary outcomes:
measure: Surgical wound infection
timeFrame: 14 days after surgery
Secondary outcomes:
measure: Atelectasis, pneumonia, respiratory insufficiency, second operation, mortality, length of postoperative hospitalization, admission to intensive care unit.
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus Sygehus
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital, Rigshospitalet
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital, Amager
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital, Bispebjerg
city: Hellerup
country: Denmark
facility: Copenhagen University Hospital, Gentofte
city: Herlev
country: Denmark
facility: Copenhagen University Hospital, Herlev
city: Holbaek
country: Denmark
facility: Holbaek Hospital
city: Kolding
country: Denmark
facility: Kolding Hospital
city: Naestved
country: Denmark
facility: Naestved Hospital
city: Nykoebing Falster
country: Denmark
facility: Nykoebing Falster Hospital
city: Slagelse
country: Denmark
facility: Slagelse Hospital
city: Svendborg
country: Denmark
facility: Funen County Hospital
city: Vejle
country: Denmark
facility: Vejle Hospital
city: Viborg
country: Denmark
facility: Viborg Hospital
Study officials:
affiliation: Dept. of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark
name: Lars S. Rasmussen, MD,DMSc,PHD
role: STUDY_CHAIR
affiliation: Copenhagen Trial Unit, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark
name: Jørn Wetterslev, MD, PHD
role: STUDY_DIRECTOR
affiliation: Dept. of Surgery, Copenhagen University Hospital, Bispebjerg, Copenhagen, Denmark
name: Lars N. Jørgensen, MD, DMSc
role: STUDY_DIRECTOR
affiliation: Dept. of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark
name: Christian S. Meyhoff, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Meyhoff CS, Wetterslev J, Jorgensen LN, Henneberg SW, Simonsen I, Pulawska T, Walker LR, Skovgaard N, Helto K, Gocht-Jensen P, Carlsson PS, Rask H, Karim S, Carlsen CG, Jensen FS, Rasmussen LS; PROXI Trial Group. Perioperative oxygen fraction - effect on surgical site infection and pulmonary complications after abdominal surgery: a randomized clinical trial. Rationale and design of the PROXI-Trial. Trials. 2008 Oct 22;9:58. doi: 10.1186/1745-6215-9-58.
citation: Meyhoff CS, Wetterslev J, Jorgensen LN, Henneberg SW, Hogdall C, Lundvall L, Svendsen PE, Mollerup H, Lunn TH, Simonsen I, Martinsen KR, Pulawska T, Bundgaard L, Bugge L, Hansen EG, Riber C, Gocht-Jensen P, Walker LR, Bendtsen A, Johansson G, Skovgaard N, Helto K, Poukinski A, Korshin A, Walli A, Bulut M, Carlsson PS, Rodt SA, Lundbech LB, Rask H, Buch N, Perdawid SK, Reza J, Jensen KV, Carlsen CG, Jensen FS, Rasmussen LS; PROXI Trial Group. Effect of high perioperative oxygen fraction on surgical site infection and pulmonary complications after abdominal surgery: the PROXI randomized clinical trial. JAMA. 2009 Oct 14;302(14):1543-50. doi: 10.1001/jama.2009.1452.