Supplemental Oxygen and Surgical-site Infections: An Alternating Intervention Controlled Trial.
Overview
- Phase
- Not Applicable
- Intervention
- 30% oxygen
- Conditions
- 30% Oxygen Concentration During Colorectal Surgery
- Sponsor
- The Cleveland Clinic
- Enrollment
- 5749
- Locations
- 1
- Primary Endpoint
- Number of Participants With One or More Composite Complications
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Detailed Description
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%.
Investigators
Andrea Kurz
Principal Investigator
The Cleveland Clinic
Eligibility Criteria
Inclusion Criteria
- •adult colorectal surgical patients
Exclusion Criteria
- Not provided
Arms & Interventions
30% oxygen
Inspired oxygen will be maintained at 30%.
Intervention: 30% oxygen
80% oxygen
Inspired oxygen will be maintained at 80%.
Intervention: 80% oxygen
Outcomes
Primary Outcomes
Number of Participants With One or More Composite Complications
Time Frame: Postoperative 30 days
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
Secondary Outcomes
- Number of Participants With Superficial SSI (Surgical Site Infection)(Postoperative 30 days)