ID

28450

Description

The ENIGMA II Trial:Nitrous Oxide Anaesthesia and Cardiac Morbidity After Major Surgery: a Randomised Controlled Trial; ODM derived from: https://clinicaltrials.gov/show/NCT00430989

Link

https://clinicaltrials.gov/show/NCT00430989

Keywords

Versions (1)
  1. 1/14/18 1/14/18 -
Copyright Holder

See clinicaltrials.gov

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January 14, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT00430989

English

Eligibility Coronary Artery Disease NCT00430989

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. adult males and females age ≥ 45 years, undergoing noncardiac surgery and general anaesthesia expected to exceed two hours.
Description

Adult | Age | Operative Surgical Procedures | Exception Cardiac Surgery procedures | General Anesthesia Expected

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0543467
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0018821
UMLS CUI [5,1]
C0002915
UMLS CUI [5,2]
C1517001
2. at increased risk of cardiac events, defined as any of
Description

Risk Increased Cardiac event

Data type

boolean

Alias
UMLS CUI [1,1]
C0035647
UMLS CUI [1,2]
C0205217
UMLS CUI [1,3]
C0741923
1. 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
Description

Coronary Artery Disease | Angina Pectoris | Myocardial Infarction | Segmental wall motion Abnormality Echocardiography | Defect Localized Radionuclide Imaging | Exercise stress test Positive Myocardial Ischemia | Exercise Positive Myocardial Ischemia Radionuclide Imaging | Exercise Positive Myocardial Ischemia Echocardiography | Cardiovascular stress test using pharmacologic stress agent Positive Myocardial Ischemia | Coronary revascularisation | Coronary Artery Bypass Surgery | Percutaneous Transluminal Coronary Angioplasty | Coronary Stenosis atherosclerotic Angiography | Coronary Stenosis Diameter Percent Coronary artery | EKG: Q wave abnormal Lead measurement Quantity

Data type

boolean

Alias
UMLS CUI [1]
C1956346
UMLS CUI [2]
C0002962
UMLS CUI [3]
C0027051
UMLS CUI [4,1]
C0807885
UMLS CUI [4,2]
C1704258
UMLS CUI [4,3]
C0013516
UMLS CUI [5,1]
C1457869
UMLS CUI [5,2]
C0392752
UMLS CUI [5,3]
C0034606
UMLS CUI [6,1]
C0015260
UMLS CUI [6,2]
C1514241
UMLS CUI [6,3]
C0151744
UMLS CUI [7,1]
C0015259
UMLS CUI [7,2]
C1514241
UMLS CUI [7,3]
C0151744
UMLS CUI [7,4]
C0034606
UMLS CUI [8,1]
C0015259
UMLS CUI [8,2]
C1514241
UMLS CUI [8,3]
C0151744
UMLS CUI [8,4]
C0013516
UMLS CUI [9,1]
C1827946
UMLS CUI [9,2]
C1514241
UMLS CUI [9,3]
C0151744
UMLS CUI [10]
C0877341
UMLS CUI [11]
C0010055
UMLS CUI [12]
C2936173
UMLS CUI [13,1]
C0242231
UMLS CUI [13,2]
C0333482
UMLS CUI [13,3]
C0002978
UMLS CUI [14,1]
C0242231
UMLS CUI [14,2]
C1301886
UMLS CUI [14,3]
C0439165
UMLS CUI [14,4]
C0205042
UMLS CUI [15,1]
C0438159
UMLS CUI [15,2]
C0524167
UMLS CUI [15,3]
C1265611
2. heart failure
Description

Heart failure

Data type

boolean

Alias
UMLS CUI [1]
C0018801
3. cerebrovascular disease thought due to atherothrombotic disease
Description

Cerebrovascular Disorders Due to Atherothrombosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0007820
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C1963943
4. aortic or peripheral vascular disease
Description

Vascular Disease Aortic | Peripheral Vascular Diseases

Data type

boolean

Alias
UMLS CUI [1,1]
C0042373
UMLS CUI [1,2]
C0003483
UMLS CUI [2]
C0085096
5. or three or more of the following risk factors:
Description

Risk factors Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C1265611
age ≥70 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
any history of congestive heart failure
Description

Congestive heart failure

Data type

boolean

Alias
UMLS CUI [1]
C0018802
diabetes and currently on an oral hypoglycaemic agent or insulin therapy
Description

Diabetes Mellitus | Oral hypoglycemic | Insulin

Data type

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2]
C0359086
UMLS CUI [3]
C0021641
current treatment for hypertension
Description

On treatment for hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0578998
preoperative serum creatinine >175 micro mol/l (> 2.0 mg/dl)
Description

Serum creatinine measurement Preoperative

Data type

boolean

Alias
UMLS CUI [1,1]
C0201976
UMLS CUI [1,2]
C0445204
current or previous high cholesterol ≥6.2 mmol/l (> 240 mg/dl)
Description

Hypercholesterolemia

Data type

boolean

Alias
UMLS CUI [1]
C0020443
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)
Description

Transient Ischemic Attack | Neurologic Deficits Focal Transient

Data type

boolean

Alias
UMLS CUI [1]
C0007787
UMLS CUI [2,1]
C0521654
UMLS CUI [2,2]
C0205234
UMLS CUI [2,3]
C0205374
emergency/urgent surgery (i.e. surgery which must be undertaken within 24 hours of acute presentation to hospital)
Description

Emergency surgery | Urgent surgical procedure

Data type

boolean

Alias
UMLS CUI [1]
C4264510
UMLS CUI [2]
C2188405
high-risk type of surgery (i.e. intrathoracic or intraperitoneal)
Description

Operative Surgical Procedures Type High risk | Thoracic Surgical Procedures | Operative Surgical Procedures Intraperitoneal

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C0332167
UMLS CUI [2]
C0524832
UMLS CUI [3,1]
C0543467
UMLS CUI [3,2]
C0442120
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. having cardiac surgery
Description

Cardiac Surgery procedures

Data type

boolean

Alias
UMLS CUI [1]
C0018821
2. marked impairment of gas-exchange expected to require fi02> 0.5 intraoperatively
Description

Impaired gas exchange Marked | FiO2 Intraoperative Patient need for

Data type

boolean

Alias
UMLS CUI [1,1]
C0150034
UMLS CUI [1,2]
C1706089
UMLS CUI [2,1]
C2370852
UMLS CUI [2,2]
C0456904
UMLS CUI [2,3]
C0686904
3. specific circumstances where n2o is contraindicated (eg. volvulus, pulmonary hypertension, raised intracranial pressure) or the anaesthetist plans to use supplemental oxygen (eg. colorectal surgery)
Description

Medical contraindication Nitrous Oxide | Volvulus | Pulmonary Hypertension | Intracranial Hypertension | Oxygen supplementation Planned | Colon and Rectal Surgery

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0028215
UMLS CUI [2]
C0042961
UMLS CUI [3]
C0020542
UMLS CUI [4]
C0151740
UMLS CUI [5,1]
C0919655
UMLS CUI [5,2]
C1301732
UMLS CUI [6]
C2608114
4. n2o unavailable for use.
Description

Nitrous Oxide Unavailable

Data type

boolean

Alias
UMLS CUI [1,1]
C0028215
UMLS CUI [1,2]
C0686905
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Similar models

Eligibility Coronary Artery Disease NCT00430989

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age | Operative Surgical Procedures | Exception Cardiac Surgery procedures | General Anesthesia Expected
Item
1. adult males and females age ≥ 45 years, undergoing noncardiac surgery and general anaesthesia expected to exceed two hours.
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0543467 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0018821 (UMLS CUI [4,2])
C0002915 (UMLS CUI [5,1])
C1517001 (UMLS CUI [5,2])
Risk Increased Cardiac event
Item
2. at increased risk of cardiac events, defined as any of
boolean
C0035647 (UMLS CUI [1,1])
C0205217 (UMLS CUI [1,2])
C0741923 (UMLS CUI [1,3])
Coronary Artery Disease | Angina Pectoris | Myocardial Infarction | Segmental wall motion Abnormality Echocardiography | Defect Localized Radionuclide Imaging | Exercise stress test Positive Myocardial Ischemia | Exercise Positive Myocardial Ischemia Radionuclide Imaging | Exercise Positive Myocardial Ischemia Echocardiography | Cardiovascular stress test using pharmacologic stress agent Positive Myocardial Ischemia | Coronary revascularisation | Coronary Artery Bypass Surgery | Percutaneous Transluminal Coronary Angioplasty | Coronary Stenosis atherosclerotic Angiography | Coronary Stenosis Diameter Percent Coronary artery | EKG: Q wave abnormal Lead measurement Quantity
Item
1. 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
boolean
C1956346 (UMLS CUI [1])
C0002962 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0807885 (UMLS CUI [4,1])
C1704258 (UMLS CUI [4,2])
C0013516 (UMLS CUI [4,3])
C1457869 (UMLS CUI [5,1])
C0392752 (UMLS CUI [5,2])
C0034606 (UMLS CUI [5,3])
C0015260 (UMLS CUI [6,1])
C1514241 (UMLS CUI [6,2])
C0151744 (UMLS CUI [6,3])
C0015259 (UMLS CUI [7,1])
C1514241 (UMLS CUI [7,2])
C0151744 (UMLS CUI [7,3])
C0034606 (UMLS CUI [7,4])
C0015259 (UMLS CUI [8,1])
C1514241 (UMLS CUI [8,2])
C0151744 (UMLS CUI [8,3])
C0013516 (UMLS CUI [8,4])
C1827946 (UMLS CUI [9,1])
C1514241 (UMLS CUI [9,2])
C0151744 (UMLS CUI [9,3])
C0877341 (UMLS CUI [10])
C0010055 (UMLS CUI [11])
C2936173 (UMLS CUI [12])
C0242231 (UMLS CUI [13,1])
C0333482 (UMLS CUI [13,2])
C0002978 (UMLS CUI [13,3])
C0242231 (UMLS CUI [14,1])
C1301886 (UMLS CUI [14,2])
C0439165 (UMLS CUI [14,3])
C0205042 (UMLS CUI [14,4])
C0438159 (UMLS CUI [15,1])
C0524167 (UMLS CUI [15,2])
C1265611 (UMLS CUI [15,3])
Heart failure
Item
2. heart failure
boolean
C0018801 (UMLS CUI [1])
Cerebrovascular Disorders Due to Atherothrombosis
Item
3. cerebrovascular disease thought due to atherothrombotic disease
boolean
C0007820 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C1963943 (UMLS CUI [1,3])
Vascular Disease Aortic | Peripheral Vascular Diseases
Item
4. aortic or peripheral vascular disease
boolean
C0042373 (UMLS CUI [1,1])
C0003483 (UMLS CUI [1,2])
C0085096 (UMLS CUI [2])
Risk factors Quantity
Item
5. or three or more of the following risk factors:
boolean
C0035648 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Age
Item
age ≥70 years
boolean
C0001779 (UMLS CUI [1])
Congestive heart failure
Item
any history of congestive heart failure
boolean
C0018802 (UMLS CUI [1])
Diabetes Mellitus | Oral hypoglycemic | Insulin
Item
diabetes and currently on an oral hypoglycaemic agent or insulin therapy
boolean
C0011849 (UMLS CUI [1])
C0359086 (UMLS CUI [2])
C0021641 (UMLS CUI [3])
On treatment for hypertension
Item
current treatment for hypertension
boolean
C0578998 (UMLS CUI [1])
Serum creatinine measurement Preoperative
Item
preoperative serum creatinine >175 micro mol/l (> 2.0 mg/dl)
boolean
C0201976 (UMLS CUI [1,1])
C0445204 (UMLS CUI [1,2])
Hypercholesterolemia
Item
current or previous high cholesterol ≥6.2 mmol/l (> 240 mg/dl)
boolean
C0020443 (UMLS CUI [1])
Transient Ischemic Attack | Neurologic Deficits Focal Transient
Item
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)
boolean
C0007787 (UMLS CUI [1])
C0521654 (UMLS CUI [2,1])
C0205234 (UMLS CUI [2,2])
C0205374 (UMLS CUI [2,3])
Emergency surgery | Urgent surgical procedure
Item
emergency/urgent surgery (i.e. surgery which must be undertaken within 24 hours of acute presentation to hospital)
boolean
C4264510 (UMLS CUI [1])
C2188405 (UMLS CUI [2])
Operative Surgical Procedures Type High risk | Thoracic Surgical Procedures | Operative Surgical Procedures Intraperitoneal
Item
high-risk type of surgery (i.e. intrathoracic or intraperitoneal)
boolean
C0543467 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0332167 (UMLS CUI [1,3])
C0524832 (UMLS CUI [2])
C0543467 (UMLS CUI [3,1])
C0442120 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Cardiac Surgery procedures
Item
1. having cardiac surgery
boolean
C0018821 (UMLS CUI [1])
Impaired gas exchange Marked | FiO2 Intraoperative Patient need for
Item
2. marked impairment of gas-exchange expected to require fi02> 0.5 intraoperatively
boolean
C0150034 (UMLS CUI [1,1])
C1706089 (UMLS CUI [1,2])
C2370852 (UMLS CUI [2,1])
C0456904 (UMLS CUI [2,2])
C0686904 (UMLS CUI [2,3])
Medical contraindication Nitrous Oxide | Volvulus | Pulmonary Hypertension | Intracranial Hypertension | Oxygen supplementation Planned | Colon and Rectal Surgery
Item
3. specific circumstances where n2o is contraindicated (eg. volvulus, pulmonary hypertension, raised intracranial pressure) or the anaesthetist plans to use supplemental oxygen (eg. colorectal surgery)
boolean
C1301624 (UMLS CUI [1,1])
C0028215 (UMLS CUI [1,2])
C0042961 (UMLS CUI [2])
C0020542 (UMLS CUI [3])
C0151740 (UMLS CUI [4])
C0919655 (UMLS CUI [5,1])
C1301732 (UMLS CUI [5,2])
C2608114 (UMLS CUI [6])
Nitrous Oxide Unavailable
Item
4. n2o unavailable for use.
boolean
C0028215 (UMLS CUI [1,1])
C0686905 (UMLS CUI [1,2])
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