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Clinical Trials/ACTRN12622000279729
ACTRN12622000279729
Active, not recruiting
未知

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

Austin Health0 sites2,325 target enrollmentFebruary 15, 2022

Overview

Phase
未知
Intervention
Not specified
Conditions
Postoperative pulmonary complications
Sponsor
Austin Health
Enrollment
2325
Status
Active, not recruiting
Last Updated
4 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 15, 2022
End Date
TBD
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

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

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.

Outcomes

Primary Outcomes

Not specified

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