ANZCTR - Registration

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12617000306314

Ethics application status

Approved

Date submitted

29/12/2016

Date registered

27/02/2017

Date last updated

27/02/2017

Type of registration

Retrospectively registered

Titles & IDs

Public title

Oxygen concentrations and responses of the immune system in surgery

Scientific title

Does variation of inspired oxygen concentration at the time of
reperfusion of the lower limb during elective knee surgery alter oxidative stress and immune activation

Secondary ID [1]

Nil Known

Universal Trial Number (UTN)

U1111-1191-2111

Trial acronym

ORIS-II

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Surgery

Reperfusion

Condition category

Condition code

Anaesthesiology

Anaesthetics

Surgery

Other surgery

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Alteration of inspired oxygen concentration prior to release of tourniquet. These patients are undergoing general anaesthesia and routinely receive oxygen administration at a concentration of 0.3 following anaesthesia induction up to 30 minutes prior to release of the lower limb tourniquet . The inspired oxygen concentration will be changed to either FiO2 = 0.3, 0.5 or 0.8 30 minutes prior to release of the tourniquet and this concentration will be continued until the end of surgery.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Control group comprised FiO2 of 0.3

Control group

Active

Outcomes

Primary outcome [1]

Plasma concentrations Isofurans

Timepoint [1]

T1 Baseline sample, prior to anaesthesia induction T2 Immediately prior to a change in oxygen concentration, 30 minutes prior to deflation of the tourniquet T3 5 minutes after T2 T4 10 minutes after T2 T5 20 minutes after T2 T6 Immediately prior to deflation of the tourniquet T7 5 minutes following deflation of the tourniquet T8 120 minutes following deflation of the tourniquet

Secondary outcome [1]

Concentrations of lymphocyte subpopulations on whole blood; The subpopulations are : B cells, T cells, CD4 , CD8 cells, Natural killer cells and naieve b cells

Timepoint [1]

35 minutes following tourniquet release

Eligibility

Key inclusion criteria

Adult patients undergoing Knee Replacement surgery requiring the use of a tourniquet for more than 60 minutes
ASA 1 - 3

Minimum age

18 Years

Maximum age

80 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Systemic infection Immunosuppressive medication
Extensive tissue trauma Multiple tourniquet episodes
Concurrent NSAID use Chronic opioid abuse, IVDU
Recent MI (< 4 weeks) CRF (creatinine > 125 micromol/l)
Liver failure Obstructive Sleep Apnoea, BMI > 40
Likely intraop O2 requirement > 50 %
or supplemental O2 preoperatively

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Opaue sealed envelopes

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Computer Sequence generation

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Phase 4

Type of endpoint/s

Pharmacokinetics / pharmacodynamics

Statistical methods / analysis

Mixed models will be employed to analyse changes over time

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

3/02/2012

Date of last participant enrolment

Anticipated

Actual

22/10/2014

Date of last data collection

Anticipated

Actual

22/10/2014

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

6000 - Perth

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Royal Perth Hospital

Address [1]

Wellington Street Perth, WA 6000

Country [1]

Australia

Primary sponsor type

Hospital

Name

Royal Perth Hospital

Address

Wellington Street
Perth
WA, 6000

Country

Australia

Secondary sponsor category [1]

None

Name [1]

None

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal perth Hospital HREC

Ethics committee address [1]

Royal Petrh Hospital
Wellington Street
Perth
WA, 6000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

08/12/2008

Approval date [1]

10/10/2011

Ethics approval number [1]

EC 2008/211

Summary

Brief summary

Surgery for many procedures involving the leg requires the surgeons to stop the blood flow for a variable period of time. During this period certain changes occur in the leg. When the blood supply is restored, these changes result in a very strong stimulus to the immune system. Some of these changes are beneficial, promoting healing of wounds and repair of damaged tissues. Some of these changes, however, can cause depression of the immune system and make infections more likely. During surgery, the anaesthetist administers anaesthetic drugs, and oxygen. The amount of oxygen that is given varies according to a number of factors. There is some evidence that the amount of oxygen in the body at the time of restoring blood supply to a limb may be of importance. This importance is in terms of the damage that may occur during surgery and the recovery from the surgery. We do not know how much oxygen is good or bad when the blood supply is restored, and we would like to perform a study looking at this question.
 At all times in this study, patients will receive at least more than the minimum amount of oxygen that is necessary for all of the bodies organs to function entirely normally, and make a complete recovery from anaesthesia and surgery.

Study protocol
After randomisation to one of the three groups, patients will receive a standardised general anaesthetic based upon the gas “Sevoflurane”. All patients will receive 30% oxygen during the surgery, up until the time of restoring blood supply to the leg. At that point patients in one of three groups will receive either 
a). 30% oxygen before the blood supply is restored and continued until the end of surgery
	-(Conventional Care)
b). 30% oxygen before the blood supply is restored and then 50 % until the end of surgery
c). 30% oxygen before the blood supply is restored and then 80 % until the end of surgery
- all of the above are in addition to the usual standard anaesthetic care.

A small ( 3 ml. ) sample of blood will be taken at ten separate times up until 2 hours after the blood supply is restored. The study period then ends for each patient at that point.

In summary, our hypothesis is that different concentrations of oxygen will produce changes in biochemistry that we wish to measure. These changes will help us to identify which is the best oxygen concentration to give to patients who are having this type of surgery.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Tomas Corcoran

Address

Department of Anaesthesia and Pain Medicine Royal Perth Hospital Wellington Street Perth WA, 6000

Country

Australia

Phone

+61414791151

Fax

[email protected]

Contact person for public queries

Name

Tomas Corcoran

Address

Department of Anaesthesia and Pain Medicine Royal Perth Hospital Wellington Street Perth, WA, 6000

Country

Australia

Phone

+61414791151

Fax

[email protected]

Contact person for scientific queries

Name

Tomas Corcoran

Address

Department of Anaesthesia and Pain Medicine Royal Perth Hospital Wellington Street Perth, WA, 6000

Country

Australia

Phone

+61414791151

Fax

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Increased inspired oxygen concentration does not adversely affect oxidative stress and the resolution of inflammation during reperfusion in patients undergoing knee replacement surgery.	2021	https://dx.doi.org/10.1080/10715762.2020.1868451

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically