Clinical trial NCT01777568: Supplemental Oxygen in Colorectal Surgery: A Quality Improvement Project
Official title: Supplemental Oxygen and Surgical-site Infections: An Alternating Intervention Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 30% Oxygen Concentration During Colorectal Surgery
80% Oxygen Concentration During Colorectal Surgery
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2013-01-29
Enrollment: 5749
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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%.

Eligibility criteria: Inclusion Criteria:

* adult colorectal surgical patients

Primary outcomes:
measure: Number of Participants With One or More Composite Complications
timeFrame: Postoperative 30 days
Secondary outcomes:
measure: Number of Participants With Superficial SSI (Surgical Site Infection)
timeFrame: Postoperative 30 days
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: Cleveand Clinic
name: Andrea Kurz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.