30% Oxygen Concentration During Colorectal Surgery, 80% Oxygen Concentration During Colorectal Surgery
Conditions
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.
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%.
Interventions
DRUG30% oxygen
Inspired oxygen will be maintained at 30%.
DRUG80% oxygen
Inspired oxygen will be maintained at 30%.
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* adult colorectal surgical patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With One or More Composite Complications | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Superficial SSI (Surgical Site Infection) | Postoperative 30 days | superficial SSI (Surgical Site Infection) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 30% Oxygen Inspired oxygen will be maintained at 30%.
30% oxygen: Inspired oxygen will be maintained at 30%. | 2,853 |
| 80% Oxygen Inspired oxygen will be maintained at 80%.
80% oxygen: Inspired oxygen will be maintained at 30%. | 2,896 |
| Total | 5,749 |
Baseline characteristics
| Characteristic | 30% Oxygen | 80% Oxygen | Total |
|---|---|---|---|
| Age, Continuous | 52 years STANDARD_DEVIATION 17 | 52 years STANDARD_DEVIATION 17 | 52 years STANDARD_DEVIATION 17 |
| Race/Ethnicity, Customized Africa American | 235 Participants | 207 Participants | 442 Participants |
| Race/Ethnicity, Customized Caucasian | 2558 Participants | 2627 Participants | 5185 Participants |
| Race/Ethnicity, Customized other | 60 Participants | 62 Participants | 122 Participants |
| Sex: Female, Male Female | 1358 Participants | 1387 Participants | 2745 Participants |
| Sex: Female, Male Male | 1495 Participants | 1509 Participants | 3004 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 10 / 2,853 | 20 / 2,896 |
| other Total, other adverse events | 183 / 2,853 | 150 / 2,896 |
| serious Total, serious adverse events | 314 / 2,853 | 314 / 2,896 |
Outcome results
Primary
Number of Participants With One or More Composite Complications
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
Time frame: Postoperative 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 30% Oxygen | Number of Participants With One or More Composite Complications | 314 Participants |
| 80% Oxygen | Number of Participants With One or More Composite Complications | 314 Participants |
p-value: 0.8595% CI: [0.85, 1.14]GEE model
Secondary
Number of Participants With Superficial SSI (Surgical Site Infection)
superficial SSI (Surgical Site Infection)
Time frame: Postoperative 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 30% Oxygen | Number of Participants With Superficial SSI (Surgical Site Infection) | 183 Participants |
| 80% Oxygen | Number of Participants With Superficial SSI (Surgical Site Infection) | 150 Participants |
p-value: 0.04795% CI: [0.66, 1.01]Chi-squared