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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%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 30% oxygen | Experimental | Inspired oxygen will be maintained at 30%. |
|
| 80% oxygen | Experimental | Inspired oxygen will be maintained at 80%. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 30% oxygen | Drug | Inspired oxygen will be maintained at 30%. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With One or More Composite Complications | A composite of complications:
| Postoperative 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Superficial SSI (Surgical Site Infection) | superficial SSI (Surgical Site Infection) | Postoperative 30 days |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Kurz, MD | Cleveand Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31094783 | Derived | Cohen B, Ahuja S, Schacham YN, Chelnick D, Mao G, Ali-Sakr Esa W, Maheshwari K, Sessler DI, Turan A. Intraoperative Hyperoxia Does Not Reduce Postoperative Pain: Subanalysis of an Alternating Cohort Trial. Anesth Analg. 2019 Jun;128(6):1160-1166. doi: 10.1213/ANE.0000000000004002. | |
| 30865003 | Derived | Cohen B, Ruetzler K, Kurz A, Leung S, Rivas E, Ezell J, Mao G, Sessler DI, Turan A. Intra-operative high inspired oxygen fraction does not increase the risk of postoperative respiratory complications: Alternating intervention clinical trial. Eur J Anaesthesiol. 2019 May;36(5):320-326. doi: 10.1097/EJA.0000000000000980. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 30% Oxygen | Inspired oxygen will be maintained at 30%. 30% oxygen: Inspired oxygen will be maintained at 30%. |
| FG001 | 80% Oxygen | Inspired oxygen will be maintained at 80%. 80% oxygen: Inspired oxygen will be maintained at 30%. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 30% Oxygen | Inspired oxygen will be maintained at 30%. 30% oxygen: Inspired oxygen will be maintained at 30%. |
| BG001 | 80% Oxygen | Inspired oxygen will be maintained at 80%. 80% oxygen: Inspired oxygen will be maintained at 30%. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With One or More Composite Complications | A composite of complications:
| Posted | Count of Participants | Participants | Postoperative 30 days |
|
30-day postoperatively
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 30% Oxygen | Inspired oxygen will be maintained at 30%. 30% oxygen: Inspired oxygen will be maintained at 30%. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| SSI (organ space/deep) | Infections and infestations | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| uperficial SSI | Infections and infestations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kurz, M.D., Andrea | Cleveland Clinic | (216) 445-9924 | KURZA@ccf.org |
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| ID | Term |
|---|---|
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
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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.
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| 80% oxygen |
| Drug |
Inspired oxygen will be maintained at 30%. |
|
| 29397118 | Derived | Kurz A, Kopyeva T, Suliman I, Podolyak A, You J, Lewis B, Vlah C, Khatib R, Keebler A, Reigert R, Seuffert M, Muzie L, Drahuschak S, Gorgun E, Stocchi L, Turan A, Sessler DI. Supplemental oxygen and surgical-site infections: an alternating intervention controlled trial. Br J Anaesth. 2018 Jan;120(1):117-126. doi: 10.1016/j.bja.2017.11.003. Epub 2017 Nov 23. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Number of Participants With Superficial SSI (Surgical Site Infection) | superficial SSI (Surgical Site Infection) | Posted | Count of Participants | Participants | Postoperative 30 days |
|
|
|
|
| 10 |
| 2,853 |
| 314 |
| 2,853 |
| 183 |
| 2,853 |
| EG001 | 80% Oxygen | Inspired oxygen will be maintained at 80%. 80% oxygen: Inspired oxygen will be maintained at 30%. | 20 | 2,896 | 314 | 2,896 | 150 | 2,896 |
| Anastomotic leak | Infections and infestations | Non-systematic Assessment |
|
| Intra-abdominal abscess | Infections and infestations | Non-systematic Assessment |
|
| sepsis | Infections and infestations | Non-systematic Assessment |
|
| wound dehiscence | Infections and infestations | Non-systematic Assessment |
|
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