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Trial record 15 of 307 for:    Recruiting, Not yet recruiting, Available Studies | "Oxygen Inhalation Therapy"

Supplemental Oxygen in Colorectal Surgery: A Quality Improvement Project

This study is currently recruiting participants.
Verified March 2017 by Andrea Kurz, The Cleveland Clinic
Sponsor:
ClinicalTrials.gov Identifier:
NCT01777568
First Posted: January 29, 2013
Last Update Posted: March 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Andrea Kurz, The Cleveland Clinic
  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.

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Andrea Kurz, The Cleveland Clinic:

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


Estimated Enrollment: 5017
Study Start Date: November 2012
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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%.

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%.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

Responsible Party: Andrea Kurz, Principal Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01777568     History of Changes
Other Study ID Numbers: 12-891
First Submitted: December 20, 2012
First Posted: January 29, 2013
Last Update Posted: March 16, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No