Supplemental Oxygen in Colorectal Surgery: A Quality Improvement Project

30% Oxygen Concentration During Colorectal Surgery Clinical Trial

Official title:

Supplemental Oxygen and Surgical-site Infections: An Alternating Intervention Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01777568
• Other study ID #: 12-891
• Status: Completed
• Phase: N/A
• Start date: November 2012
• Est. completion date: November 2016

Study information

• Verified date: April 2019
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5749
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• adult colorectal surgical patients

Related Conditions & MeSH terms

• 30% Oxygen Concentration During Colorectal Surgery
• 80% Oxygen Concentration During Colorectal Surgery

Intervention

Drug:
• 30% oxygen
Inspired oxygen will be maintained at 30%.
• 80% oxygen
Inspired oxygen will be maintained at 30%.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With One or More Composite Complications	A composite of complications: surgical sites infection (organ space / deep); Anastomotic leak; Intra-abdominal abscess; Sepsis; Wound dehiscence; Death	Postoperative 30 days
Secondary	Number of Participants With Superficial SSI (Surgical Site Infection)	superficial SSI (Surgical Site Infection)	Postoperative 30 days