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Supplemental Oxygen in Colorectal Surgery: A Quality Improvement Project

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ClinicalTrials.gov Identifier: NCT01777568
Recruitment Status : Recruiting
First Posted : January 29, 2013
Last Update Posted : March 12, 2018
Sponsor:
Information provided by (Responsible Party):
Andrea Kurz, 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.

Condition or disease Intervention/treatment
30% Oxygen Concentration During Colorectal Surgery 80% Oxygen Concentration During Colorectal Surgery Drug: 30% oxygen Drug: 80% oxygen

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 : Observational
Estimated Enrollment : 5017 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : November 2012
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy
U.S. FDA Resources

Group/Cohort Intervention/treatment
30% oxygen
Inspired oxygen will be maintained at 30%.
Drug: 30% oxygen
Inspired oxygen will be maintained at 30%.
80% oxygen
Inspired oxygen will be maintained at 80%.
Drug: 80% oxygen
Inspired oxygen will be maintained at 30%.



Primary Outcome Measures :
  1. Surgical site infection and related complications [ Time Frame: Postoperative 30 days ]
    A composite of surgical sites infection and potentially oxygen-related wound complications.


Secondary Outcome Measures :
  1. Cost of care [ Time Frame: Postoperative 30 days ]
    Incremental cost of care with 30% versus 80% oxygen.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult colorectal surgical patients.
Criteria

Inclusion Criteria:

  • adult colorectal surgical patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01777568


Contacts
Contact: Andrea Kurz, MD 216-445-9924 ak@or.org
Contact: Gretchen Upton 216-905-3932 uptong@ccf.org

Locations
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Andrea Kurz, MD    216-444-9924    ak@or.org   
Contact: Gretchen Upton    216-905-3932    uptong@ccf.org   
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Andrea Kurz, MD Cleveand Clinic

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Andrea Kurz, Principal Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01777568     History of Changes
Other Study ID Numbers: 12-891
First Posted: January 29, 2013    Key Record Dates
Last Update Posted: March 12, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No