Supplemental Oxygen in Colorectal Surgery: A Quality Improvement Project

NeuroTherapia, Inc.

Status: Completed

Conditions: 80% Oxygen Concentration During Colorectal Surgery; 30% Oxygen Concentration During Colorectal Surgery

Treatments: Drug: 80% oxygen; Drug: 30% oxygen

Study type: Interventional

Funder types: Other

Identifiers

NCT01777568

12-891

Details and patient eligibility

About

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.

Full 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%.

Enrollment: 5,749 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• adult colorectal surgical patients

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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5,749 participants in 2 patient groups

30% oxygen

Experimental group

Description:

Inspired oxygen will be maintained at 30%.

Treatment:

Drug: 30% oxygen

80% oxygen

Experimental group

Description:

Inspired oxygen will be maintained at 80%.

Treatment:

Drug: 80% oxygen