Supplemental Oxygen in Colorectal Surgery: A Quality Improvement Project

Not Applicable

Completed

• Conditions: 80% Oxygen Concentration During Colorectal Surgery; 30% Oxygen Concentration During Colorectal Surgery
• Interventions: Drug: 30% oxygen; Drug: 80% oxygen

• Registration Number: NCT01777568
• Lead Sponsor: The Cleveland Clinic

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%.

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-12-20
• Study First Submitted QC: 2013-01-28
• Study First Posted: 2013-01-29
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Results First Submitted: 2018-07-16
• Status Verified: 2019-04
• Results First Submitted QC: 2019-04-02
• Last Update Submitted: 2019-04-02
• Results First Posted: 2019-04-05
• Last Update Posted: 2019-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5749

Inclusion Criteria

• adult colorectal surgical patients

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
30% oxygen	30% oxygen	Inspired oxygen will be maintained at 30%.
80% oxygen	80% oxygen	Inspired oxygen will be maintained at 80%.

Primary Outcome Measures

Name	Time	Method
Number of Participants With One or More Composite Complications	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 Outcome Measures

Name	Time	Method
Number of Participants With Superficial SSI (Surgical Site Infection)	Postoperative 30 days	superficial SSI (Surgical Site Infection)

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States