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Supplemental Oxygen in Colorectal Surgery: A Quality Improvement Project

This study is currently recruiting participants.
Verified January 2013 by The Cleveland Clinic
Sponsor:
Information provided by (Responsible Party):
Andrea Kurz, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01777568
First received: December 20, 2012
Last updated: January 28, 2013
Last verified: January 2013
History of Changes
  Purpose

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. 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%.


Condition Intervention
Oxygen Concentration During Colorectal Surgery
 Other: 30% oxgen
Other: 80% oxygen

Study Type: Observational
Study Design: Time Perspective: Prospective

Resource links provided by NLM:

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

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • determining optimal intraoperative oxygen concentration [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Our primary objective is to develop a clinical pathway for care of patients having colo-rectal surgery at the Clinic. In particular, we would like to determine what intraoperative concentration of supplemental oxygen (30% or 80%)is optimal in our patients. As a safety measure, enough oxygen will always be given to maintain oxygen saturation (as determined by pulse oximetry) ≥95%.


Secondary Outcome Measures:
  • cost benefit analysis for oxygen concentration [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Secondarily, we will assess the incremental cost benefit of 80% versus 30% oxygen


Estimated Enrollment: 5017
Study Start Date: November 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
30 % oxygen
Operating room will be maintained at 30% oxygenation during colorectal surgery.
 Other: 30% oxgen
Operating room will be maintained at 30% oxygenation during colorectal surgery.
80 % oxygen
Operating room will be maintained at 80% oxygenation during colorectal surgery.
 Other: 80% oxygen
Operating room will be maintained at 80% oxygenation.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

adult colorectal surgical patients

Criteria

Inclusion Criteria:

  • adult colorectal surgical patients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Andrea Kurz, Principal Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01777568     History of Changes
Other Study ID Numbers: 12-891
Study First Received: December 20, 2012
Last Updated: January 28, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on June 18, 2013