N/A N=5,749 Randomized Single-blind Supportive Care

Supplemental Oxygen in Colorectal Surgery: A Quality Improvement Project

30% Oxygen Concentration During Colorectal Surgery · 80% Oxygen Concentration During Colorectal Surgery

Bottom Line

View on ClinicalTrials.gov: NCT01777568 ↗

Enrolled (actual)

5,749

Serious AEs

10.9%

Results posted

Apr 2019

Primary outcome: Primary: Number of Participants With One or More Composite Complications — 314; 314 Participants — p=0.85

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: 30% oxygen (Drug); 80% oxygen (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: The Cleveland Clinic
Primary completion: Nov 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With One or More Composite Complications	314; 314	0.85
SECONDARY Number of Participants With Superficial SSI (Surgical Site Infection)	183; 150	0.047 sig

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.

Eligibility Criteria

Inclusion Criteria

adult colorectal surgical patients

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01777568). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.