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Supplemental Oxygen in Colorectal Surgery: A Quality Improvement Project

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ClinicalTrials.gov Identifier: NCT01777568
Recruitment Status : Completed
First Posted : January 29, 2013
Results First Posted : April 5, 2019
Last Update Posted : April 5, 2019
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 Phase
30% Oxygen Concentration During Colorectal Surgery 80% Oxygen Concentration During Colorectal Surgery Drug: 30% oxygen Drug: 80% oxygen Not Applicable

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%.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5749 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The designated operating-room suite alternated between using either 30% oxygen as tolerated or 80% oxygen for periods of 2 weeks. For example, the first period used 30% oxygen, the second 80% oxygen, and so on. The oxygen concentration during the initial period was randomly designated by the study statistician. But, thereafter, oxygen delivery was not randomized on a per-patient or even per-period basis.
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Supplemental Oxygen and Surgical-site Infections: An Alternating Intervention Controlled Trial.
Actual Study Start Date : November 2012
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

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%.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Number of Participants With Superficial SSI (Surgical Site Infection) [ Time Frame: Postoperative 30 days ]
    superficial SSI (Surgical Site Infection)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Locations
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United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
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Principal Investigator: Andrea Kurz, MD Cleveand Clinic