Skip to main content
OpenTrials
Completed

NCT Number: NCT01777568

Supplemental Oxygen in Colorectal Surgery: A Quality Improvement Project

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

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%.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adult colorectal surgical patients

Treatment and study plan

30% Oxygen

Drug

Inspired oxygen will be maintained at 30%.

80% Oxygen

Drug

Inspired oxygen will be maintained at 30%.

Primary outcomes

  1. Number of Participants With One or More Composite Complications

    Time frame: Postoperative 30 days

    A composite of complications:

    • surgical sites infection (organ space / deep)
    • Anastomotic leak
    • Intra-abdominal abscess
    • Sepsis
    • Wound dehiscence
    • Death

Secondary outcomes

  1. Number of Participants With Superficial SSI (Surgical Site Infection)

    Time frame: Postoperative 30 days

    superficial SSI (Surgical Site Infection)

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

Supplemental Oxygen and Surgical-site Infections: An Alternating Intervention Controlled Trial.

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jan 29, 2013
Registry last updated
Apr 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.