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Trial record 15 of 297 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.
See Contacts and Locations
Verified March 2017 by Andrea Kurz, 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: March 14, 2017
Last verified: March 2017
  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

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
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, see Learn About Clinical Studies.

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

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: March 14, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

ClinicalTrials.gov processed this record on July 21, 2017