Supplemental Oxygen in Colorectal Surgery: A Quality Improvement Project

April 2, 2019 updated by: Andrea Kurz, The Cleveland Clinic

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

5749

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • adult colorectal surgical patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 30% oxygen
Inspired oxygen will be maintained at 30%.
Drug: 30% oxygen
Inspired oxygen will be maintained at 30%.
Experimental: 80% oxygen
Inspired oxygen will be maintained at 80%.
Drug: 80% oxygen
Inspired oxygen will be maintained at 30%.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Postoperative 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Superficial SSI (Surgical Site Infection)
Time Frame: Postoperative 30 days
superficial SSI (Surgical Site Infection)
Postoperative 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Investigators

  • Principal Investigator: Andrea Kurz, MD, Cleveand Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2012

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

December 20, 2012

First Submitted That Met QC Criteria

January 28, 2013

First Posted (Estimate)

January 29, 2013

Study Record Updates

Last Update Posted (Actual)

April 5, 2019

Last Update Submitted That Met QC Criteria

April 2, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 12-891

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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