Our primary objective is to develop a clinical pathway for care of patients having colorectal surgery at the Clinic. In particular, the investigators would like to determine what intraoperative concentration of oxygen is optimal in our patients.
The investigators therefore propose to test the primary hypothesis that supplemental oxygen (80% versus 30%) reduces the risk of a composite of surgical sites infection and potentially oxygen-related wound complications. Secondarily, the investigators will assess the incremental cost benefit of 80% versus 30% oxygen. As a safety measure, enough oxygen will always be given to maintain oxygen saturation (as determined by pulse oximetry) ≥95%.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
5,749
Inspired oxygen will be maintained at 30%.
Inspired oxygen will be maintained at 30%.
Cleveland Clinic
Cleveland, Ohio, United States
Number of Participants With One or More Composite Complications
A composite of complications: 1. surgical sites infection (organ space / deep) 2. Anastomotic leak 3. Intra-abdominal abscess 4. Sepsis 5. Wound dehiscence 6. Death
Time frame: Postoperative 30 days
Number of Participants With Superficial SSI (Surgical Site Infection)
superficial SSI (Surgical Site Infection)
Time frame: Postoperative 30 days
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