30% Oxygen Concentration During Colorectal SurgeryNCT01777568

Supplemental Oxygen in Colorectal Surgery: A Quality Improvement Project

A study testing 30% oxygen and 80% oxygen in people with 30% Oxygen Concentration During Colorectal Surgery and 80% Oxygen Concentration During Colorectal Surgery, run by The Cleveland Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: 30% Oxygen Concentration During Colorectal Surgery, 80% Oxygen Concentration During Colorectal Surgery
What is being tested?: 30% oxygen and 80% oxygen
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 5,749 participants
Where: 1 siteUnited States
Study dates: Nov 2012to Nov 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

adult colorectal surgical patients

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

Cleveland Clinic
Cleveland, Ohio, 44195

Other trials in United States

About this study

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

Read the 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%.

Conditions: 30% Oxygen Concentration During Colorectal Surgery, 80% Oxygen Concentration During Colorectal Surgery
Being tested: 30% oxygen, 80% oxygen

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

30% oxygenDrug
Inspired oxygen will be maintained at 30%.
80% oxygenDrug
Inspired oxygen will be maintained at 30%.

Study groups in NCT01777568
Study group	Role	What they receive
30% oxygen	Experimental	Inspired oxygen will be maintained at 30%. Receives: Drug: 30% oxygen
80% oxygen	Experimental	Inspired oxygen will be maintained at 80%. Receives: Drug: 80% oxygen

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Postoperative 30 days

Secondary outcomes (1)

Number of Participants With Superficial SSI (Surgical Site Infection)
superficial SSI (Surgical Site Infection)
Measured: Postoperative 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2012Nov 2016

First posted29 Jan 2013 (estimated)
Study startNov 2012
Primary completionNov 2016
Study completionNov 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for 30% Oxygen Concentration During Colorectal SurgeryStudies of the same condition, open and under way.
More trials run by The Cleveland ClinicThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
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.
Masking: Single blind
Who is masked: Participant
Enrolment: 5,749 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01777568
Sponsor's protocol ID: 12-891
Status last verified: Apr 2019
First submitted: 20 Dec 2012
Last updated: 5 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 31094783
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.
PubMed 30865003
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.
PubMed 29397118

Study at a glance

From the registry record, last updated by the sponsor on 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Supplemental Oxygen and Surgical-site Infections: An Alternating Intervention Controlled Trial.
ClinicalTrials.gov ID: NCT01777568
Acronym / sponsor ID: 12-891
Conditions: 30% Oxygen Concentration During Colorectal Surgery, 80% Oxygen Concentration During Colorectal Surgery
Study type: Interventional
Recruitment status: Completed
Enrolment: 5,749 participants (actual)
Lead sponsor: The Cleveland ClinicUniversity, hospital or other
Study start: Nov 2012 (actual)
Primary completion: Nov 2016 (actual)
Study completion: Nov 2016 (actual)
First posted: 29 Jan 2013 (estimated)
Results: Posted 5 Apr 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
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.

Arm	Type	Receives
30% oxygen	Experimental	Drug: 30% oxygenInspired oxygen will be maintained at 30%.
80% oxygen	Experimental	Drug: 80% oxygenInspired oxygen will be maintained at 80%.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

adult colorectal surgical patients

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
30% oxygenInspired oxygen will be maintained at 30%.	Drug	30% oxygen
80% oxygenInspired oxygen will be maintained at 30%.	Drug	80% oxygen

Primary outcome

Number of Participants With One or More Composite Complications
Time frame: 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

1 secondary outcome

Number of Participants With Superficial SSI (Surgical Site Infection)
Time frame: Postoperative 30 days

Results and safety

Results posted to the registry on 5 Apr 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
30% Oxygen	2,853	2,853
80% Oxygen	2,896	2,896

Primary outcome: Number of Participants With One or More Composite Complications

Time frame: Postoperative 30 days. Count of participants. Unit: Participants

Measure	30% Oxygen n = 2853	80% Oxygen n = 2896
Value	314	314

30% Oxygen vs 80% Oxygen: Risk Ratio (RR): 0.99 (95% CI 0.85 to 1.14), p = 0.85, GEE model

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 30-day postoperatively. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
30% Oxygen	314 of 2,853 (11%)	183 of 2,853 (6.4%)	10 of 2,853
80% Oxygen	314 of 2,896 (10.8%)	150 of 2,896 (5.2%)	20 of 2,896

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31094783Cohen 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.
Derived from this study: PubMed 30865003Cohen 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.
Derived from this study: PubMed 29397118Kurz 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.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Andrea Kurz, MD principal investigator

Cleveand Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With One or More Composite Complications (time frame: Postoperative 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01777568, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2019.