NCT01777568

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,749

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 29, 2013

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

April 5, 2019

Completed
Last Updated

April 5, 2019

Status Verified

April 1, 2019

Enrollment Period

4 years

First QC Date

December 20, 2012

Results QC Date

July 16, 2018

Last Update Submit

April 2, 2019

Conditions

30% Oxygen Concentration During Colorectal Surgery80% Oxygen Concentration During Colorectal Surgery

Outcome Measures

Primary Outcomes (1)

  • 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

    Postoperative 30 days

Secondary Outcomes (1)

  • Number of Participants With Superficial SSI (Surgical Site Infection)

    Postoperative 30 days

Study Arms (2)

30% oxygen

EXPERIMENTAL

Inspired oxygen will be maintained at 30%.

Drug: 30% oxygen

80% oxygen

EXPERIMENTAL

Inspired oxygen will be maintained at 80%.

Drug: 80% oxygen

Interventions

30% oxygenDRUG

Inspired oxygen will be maintained at 30%.

30% oxygen
80% oxygenDRUG

Inspired oxygen will be maintained at 30%.

80% oxygen

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult colorectal surgical patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (3)

  • 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.

    PMID: 31094783DERIVED

  • 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.

    PMID: 30865003DERIVED

  • 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.

    PMID: 29397118DERIVED

MeSH Terms

Interventions

Oxygen

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGases

Results Point of Contact

Title
Kurz, M.D., Andrea
Organization
Cleveland Clinic
KURZA@ccf.org
(216) 445-9924

Study Officials

  • Andrea Kurz, MD

    Cleveand Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 20, 2012

First Posted

January 29, 2013

Study Start

November 1, 2012

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

April 5, 2019

Results First Posted

April 5, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)