ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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

ACTRN12622000279729

Ethics application status

Approved

Date submitted

21/01/2022

Date registered

15/02/2022

Date last updated

15/02/2022

Date data sharing statement initially provided

15/02/2022

Type of registration

Retrospectively registered

Titles & IDs

Public title

Postoperative pulmonary complications in the ENIGMA 2 Trial

Scientific title

Postoperative pulmonary complications (atelectasis and pneumonia) in the ENIGMA 2 Trial

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

This is a follow up study of the ENIGMA 2 Trial NCT00430989

Health condition

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

Postoperative pulmonary complications

Condition category

Condition code

Respiratory

Other respiratory disorders / diseases

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

This study is investigating additional postoperative patient outcomes within 30 days of index suergy in pre-existing patients who were recruited to the ENIGMA 2 Trial (which was conducted between May 30, 2008 and Sept 28, 2013), which did not collect pulmonary complications data at the time of the trial. Data collection for the study involves retrospective inspection of individual patient hospital medical records from the index hospital admission and surgery, to collect the required data on postoperative pulmonary complications following the index surgery. The trial intervention group received 70% nitrous oxide in oxygen inspired in the breathing circuit as part of inhalational general anaesthesia, delivered from post-induction of anaesthesia until end of surgery. The N2O concentration could be adjusted if the FIO2 is required to be increased due to arterial oxygen saturation measurements on the judgement of the attending anaesthetist.

Intervention code [1]

Not applicable

Comparator / control treatment

The control group in the ENIGMA 2 trial received 30% oxygen in air inspired in the breathing circuit as part of inhalational general anaesthesia, delivered from post-induction of anaesthesia until end of surgery. The FIO2 could be increased if required due to arterial oxygen saturation measurements on the judgement of the attending anaesthetist.

Control group

Active

Outcomes

Primary outcome [1]

Postoperative pulmonary atelectasis, confirmed by chest radiology report, recorded on the patients electronic hospital medical record within 30 days of their index surgery for the ENIGMA 2 Trial, extracted using data-linkage to medical records, with no active participant involvement.

Timepoint [1]

Up to 30 days postoperative

Secondary outcome [1]

Postoperative pneumonia, confirmed by the presence of a diagnostic pulmonary infiltrate on chest radiology report, along with one or more of a blood WCC >/= 12,000/mL, temperature >/= 38C, or positive sputum microbiological culture, recorded on the patients electronic hospital medical record within 30 days of their index surgery for the ENIGMA 2 Trial, extracted using data-linkage to medical records, with no active participant involvement.

Timepoint [1]

Up to 30 days postoperative

Eligibility

Key inclusion criteria

Participants randomised to the ENIGMA 2 Trial within Australia, according to the ENIGMA 2 inclusion criteria:
Adult males and females age >/= 45 years, undergoing noncardiac surgery and general anaesthesia expected to exceed two hours.
At increased risk of cardiac events, defined as any of
history of coronary artery disease as defined by a history of any one of the following: i. angina ii. MI iii. segmental wall motion abnormality on echocardiography or a fixed defect on radionuclide imaging iv. a positive exercise stress test for cardiac ischaemia v. a positive radionuclide exercise, echocardiographic exercise, or pharmacological cardiovascular stress test for cardiac ischaemia vi. coronary revascularization (CABG or PTCA) vii. angiographic evidence of atherosclerotic stenosis > 50% of the diameter of any coronary artery viii. ECG with pathological Q waves in two contiguous leads
heart failure
cerebrovascular disease thought due to atherothrombotic disease
aortic or peripheral vascular disease
or three or more of the following risk factors:
age >/=70 years
any history of congestive heart failure
diabetes and currently on an oral hypoglycaemic agent or insulin therapy
current treatment for hypertension
preoperative serum creatinine >175 micro mol/L (> 2.0 mg/dl)
current or previous high cholesterol >6.2 mmol/L (> 240 mg/dl)
history of a transient ischemic attack (TIA) (i.e. a transient focal neurological deficit that lasted less than 24 hours and thought to be vascular in origin)
emergency/urgent surgery (i.e. surgery which must be undertaken within 24 hours of acute presentation to hospital) high-risk type of surgery (i.e. intrathoracic or intraperitoneal)

Minimum age

45 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

having cardiac surgery
marked impairment of gas-exchange expected to require Fi02> 0.5 intraoperatively
specific circumstances where N2O is contraindicated (eg. volvulus, pulmonary hypertension, raised intracranial pressure) or the anaesthetist plans to use supplemental oxygen (eg. colorectal surgery)
N2O unavailable for use.

Study design

Purpose

Duration

Selection

Defined population

Timing

Retrospective

Statistical methods / analysis

Primary and secondary endpoint statistical comparisons were done using the Chi-square test.

Recruitment

Recruitment status

Active, not recruiting

Date of first participant enrolment

Anticipated

Actual

1/12/2018

Date of last participant enrolment

Anticipated

Actual

2/02/2022

Date of last data collection

Anticipated

31/03/2022

Actual

Sample size

Target

2325

Accrual to date

Final

2325

Recruitment in Australia

Recruitment state(s)

NSW,WA,VIC

Recruitment hospital [1]

The Alfred - Melbourne

Recruitment hospital [2]

Royal Melbourne Hospital - Royal Park campus - Parkville

Recruitment hospital [3]

St Vincent's Hospital (Melbourne) Ltd - Fitzroy

Recruitment hospital [4]

Austin Health - Austin Hospital - Heidelberg

Recruitment hospital [5]

Monash Medical Centre - Clayton campus - Clayton

Recruitment hospital [6]

Dandenong Hospital- Monash Health - Dandenong

Recruitment hospital [7]

Royal Perth Hospital - Perth

Recruitment hospital [8]

Westmead Hospital - Westmead

Recruitment hospital [9]

Fremantle Hospital and Health Service - Fremantle

Recruitment postcode(s) [1]

3004 - Melbourne

Recruitment postcode(s) [2]

3052 - Parkville

Recruitment postcode(s) [3]

3065 - Fitzroy

Recruitment postcode(s) [4]

3084 - Heidelberg

Recruitment postcode(s) [5]

3168 - Clayton

Recruitment postcode(s) [6]

3175 - Dandenong

Recruitment postcode(s) [7]

6000 - Perth

Recruitment postcode(s) [8]

2145 - Westmead

Recruitment postcode(s) [9]

6160 - Fremantle

Funding & Sponsors

Funding source category [1]

Other

Name [1]

Dept of Anaesthesia, Austin Health

Address [1]

Studley Rd
Heidelberg VIC 3084

Country [1]

Australia

Primary sponsor type

Hospital

Name

Austin Health

Address

Studley Rd
Heidelberg VIC 3084

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Austin Health Human Research Ethics Committee

Ethics committee address [1]

Studley Rd
Heidelberg VIC 3084

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

07/11/2018

Ethics approval number [1]

HREC/46023/Austin-2018

Summary

Brief summary

The ENIGMA (Evaluation of Nitrous oxide In the Gas Mixture in Anaesthesia) Trial was a large (n = 2,050) pragmatic multicentre randomised trial in patients undergoing major surgery. The incidence of clinically significant postoperative pulmonary complications (PPCs) measured by routine chest radiography and postoperative full blood and microbiology testing, as well a septic complications, were found to be increased with N2O. The larger ENIGMA 2 Trial (n = 7,000) did not confirm the findings of ENIGMA that N2O increased rates of wound infection or sepsis. Unfortunately, ENIGMA 2 did not prospectively collect data on pulmonary complications. Given the pragmatic nature of the protocol for measurement of PPC incidence used in ENIGMA, it was seen as feasible to replicate it post hoc in the ENIGMA 2 trial sample, using data collected as part of routine postoperative clinical management in these patients. This was done in the cohort of patients recruited to the ENIGMA 2 Trial within Australia, which consisted of over 2,500 patients or approximately 35% of total trial recruitment.

Trial website

Trial related presentations / publications

Public notes

This is a retrospective study of data on pulmonary complications collected in patients recruited to the ENIGMA 2 Trial, between 2007-13.

Contacts

Principal investigator

Name

Prof Philip Peyton

Address

Dept of Anaesthesia
Austin Health
Studley Rd
Heidelberg
VIC 3084

Country

Australia

Phone

+61 3 94965000

Fax

phil.peyton@austin.org.au

Contact person for public queries

Name

Philip Peyton

Address

Dept of Anaesthesia
Austin Health
Studley Rd
Heidelberg
VIC 3084

Country

Australia

Phone

+61 3 94965000

Fax

phil.peyton@austin.org.au

Contact person for scientific queries

Name

Philip Peyton

Address

Dept of Anaesthesia
Austin Health
Studley Rd
Heidelberg
VIC 3084

Country

Australia

Phone

+61 3 94965000

Fax

phil.peyton@austin.org.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

Primary and secondary endpoint data

When will data be available (start and end dates)?

31/12/2022 after publication of results, available for 5 years.

Available to whom?

Please contact the Principal Investigator to discuss

Available for what types of analyses?

Please contact the Principal Investigator to discuss

How or where can data be obtained?

Please contact the Principal Investigator to discuss: phil.peyton@austin .org.au

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
14659	Study protocol				Please contact the Principal Investigator to discu... [More Details]
14660	Ethical approval				Please contact the Principal Investigator to discu... [More Details]

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically