Trial Outcomes & Findings for Supplemental Oxygen in Colorectal Surgery: A Quality Improvement Project (NCT NCT01777568)

NCT ID: NCT01777568

Last Updated: 2019-04-05

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 5749 participants
• Primary outcome timeframe: Postoperative 30 days
• Results posted on: 2019-04-05

Participant Flow

Participant milestones

Measure	30% Oxygen Inspired oxygen will be maintained at 30%. 30% oxygen: Inspired oxygen will be maintained at 30%.	80% Oxygen Inspired oxygen will be maintained at 80%. 80% oxygen: Inspired oxygen will be maintained at 30%.
Overall Study STARTED	2853	2896
Overall Study COMPLETED	2853	2896
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Supplemental Oxygen in Colorectal Surgery: A Quality Improvement Project

Baseline characteristics by cohort

Measure	30% Oxygen n=2853 Participants Inspired oxygen will be maintained at 30%. 30% oxygen: Inspired oxygen will be maintained at 30%.	80% Oxygen n=2896 Participants Inspired oxygen will be maintained at 80%. 80% oxygen: Inspired oxygen will be maintained at 30%.	Total n=5749 Participants Total of all reporting groups
Age, Continuous	52 years STANDARD_DEVIATION 17 • n=5 Participants	52 years STANDARD_DEVIATION 17 • n=7 Participants	52 years STANDARD_DEVIATION 17 • n=5 Participants
Sex: Female, Male Female	1358 Participants n=5 Participants	1387 Participants n=7 Participants	2745 Participants n=5 Participants
Sex: Female, Male Male	1495 Participants n=5 Participants	1509 Participants n=7 Participants	3004 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	2558 Participants n=5 Participants	2627 Participants n=7 Participants	5185 Participants n=5 Participants
Race/Ethnicity, Customized Africa American	235 Participants n=5 Participants	207 Participants n=7 Participants	442 Participants n=5 Participants
Race/Ethnicity, Customized other	60 Participants n=5 Participants	62 Participants n=7 Participants	122 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	30% Oxygen n=2853 Participants Inspired oxygen will be maintained at 30%. 30% oxygen: Inspired oxygen will be maintained at 30%.	80% Oxygen n=2896 Participants Inspired oxygen will be maintained at 80%. 80% oxygen: Inspired oxygen will be maintained at 30%.
Number of Participants With One or More Composite Complications	314 Participants	314 Participants

SECONDARY outcome

Timeframe: Postoperative 30 days

superficial SSI (Surgical Site Infection)

Outcome measures

Measure	30% Oxygen n=2853 Participants Inspired oxygen will be maintained at 30%. 30% oxygen: Inspired oxygen will be maintained at 30%.	80% Oxygen n=2896 Participants Inspired oxygen will be maintained at 80%. 80% oxygen: Inspired oxygen will be maintained at 30%.
Number of Participants With Superficial SSI (Surgical Site Infection)	183 Participants	150 Participants

Adverse Events

30% Oxygen

Serious events: 314 serious events

Other events: 183 other events

Deaths: 10 deaths

80% Oxygen

Serious events: 314 serious events

Other events: 150 other events

Deaths: 20 deaths

Serious adverse events

Measure	30% Oxygen n=2853 participants at risk Inspired oxygen will be maintained at 30%. 30% oxygen: Inspired oxygen will be maintained at 30%.	80% Oxygen n=2896 participants at risk Inspired oxygen will be maintained at 80%. 80% oxygen: Inspired oxygen will be maintained at 30%.
Infections and infestations SSI (organ space/deep)	3.9% 112/2853 • Number of events 112 • 30-day postoperatively	4.1% 118/2896 • Number of events 118 • 30-day postoperatively
Infections and infestations Anastomotic leak	1.3% 36/2853 • Number of events 36 • 30-day postoperatively	1.2% 34/2896 • Number of events 34 • 30-day postoperatively
Infections and infestations Intra-abdominal abscess	5.0% 143/2853 • Number of events 143 • 30-day postoperatively	4.6% 133/2896 • Number of events 133 • 30-day postoperatively
Infections and infestations sepsis	3.3% 94/2853 • Number of events 94 • 30-day postoperatively	3.3% 96/2896 • Number of events 96 • 30-day postoperatively
Infections and infestations wound dehiscence	1.5% 43/2853 • Number of events 43 • 30-day postoperatively	1.5% 43/2896 • Number of events 43 • 30-day postoperatively

Other adverse events

Measure	30% Oxygen n=2853 participants at risk Inspired oxygen will be maintained at 30%. 30% oxygen: Inspired oxygen will be maintained at 30%.	80% Oxygen n=2896 participants at risk Inspired oxygen will be maintained at 80%. 80% oxygen: Inspired oxygen will be maintained at 30%.
Infections and infestations uperficial SSI	6.4% 183/2853 • Number of events 183 • 30-day postoperatively	5.2% 150/2896 • Number of events 150 • 30-day postoperatively

Additional Information

Kurz, M.D., Andrea

Cleveland Clinic

Phone: (216) 445-9924

Email: KURZA@ccf.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place