Status:
COMPLETED
Supplemental Oxygen and Complications After Abdominal Surgery (The PROXI-trial)
Lead Sponsor:
Rigshospitalet, Denmark
Collaborating Sponsors:
The Danish Medical Research Council
Conditions:
Laparotomy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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. ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
1400 Patients enrolled
Trial Details
Trial ID
NCT00364741
Start Date
October 1 2006
End Date
November 1 2008
Last Update
October 16 2009
Active Locations (14)
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1
Aarhus Sygehus
Aarhus, Denmark, DK-8000
2
Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark, DK-2100
3
Copenhagen University Hospital, Amager
Copenhagen, Denmark, DK-2300
4
Copenhagen University Hospital, Bispebjerg
Copenhagen, Denmark, DK-2400