ID

28496

Description

Evaluation of the Accuracy, Safety and Robustness of a Single-input-single-output (SISO) Model-based Predictive Closed-loop System to Guide Patient-individualized ICU Sedation; ODM derived from: https://clinicaltrials.gov/show/NCT00735631

Link

https://clinicaltrials.gov/show/NCT00735631

Keywords

Versions (1)
  1. 1/19/18 1/19/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 19, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT00735631

English

Eligibility Coronary Artery Disease NCT00735631

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients in the immediate post-operative phase after an coronary artery reconstruction surgery.
Description

Coronary artery reconstruction Postoperative Period

Data type

boolean

Alias
UMLS CUI [1,1]
C1293393
UMLS CUI [1,2]
C0032790
age >= 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
informed consent obtained before the surgery
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
severe renal failure defined by the rifle classification levels risk, failure and end-stage kidney failure
Description

Kidney Failure Severe | Other Coding Classification Levels Risk | Kidney Failure | Kidney Failure, Chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C0035078
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C3846158
UMLS CUI [2,2]
C0008902
UMLS CUI [2,3]
C0441889
UMLS CUI [2,4]
C0035647
UMLS CUI [3]
C0035078
UMLS CUI [4]
C0022661
severe hepatic failure defined by a bilirubin level of >= 3 mg/dl and/or a prothrombin level of < 50% before the surgery
Description

Liver Failure Severe | Serum total bilirubin measurement | Prothrombin level

Data type

boolean

Alias
UMLS CUI [1,1]
C0085605
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0369903
low ejection fraction defined as < 40%
Description

Ejection fraction decreased

Data type

boolean

Alias
UMLS CUI [1]
C0743400
age < 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
postoperative bleeding so that a new surgery is necessary
Description

Postoperative Hemorrhage | Operative Surgical Procedure New Patient need for

Data type

boolean

Alias
UMLS CUI [1]
C0032788
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0205314
UMLS CUI [2,3]
C0686904
history of cardiovascular accident (cva)
Description

Cardiovascular accident

Data type

boolean

Alias
UMLS CUI [1]
C1386002
history of copd
Description

COPD

Data type

boolean

Alias
UMLS CUI [1]
C0024117
age > 75 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
postoperative cardiac index < 2.2 for more than 2 hours
Description

Cardiac index Postoperative

Data type

boolean

Alias
UMLS CUI [1,1]
C0428776
UMLS CUI [1,2]
C0032790
svo2 < 60% for more than 2 hours
Description

SvO2

Data type

boolean

Alias
UMLS CUI [1]
C0428176
hypotension with a map < 60 mmhg for more than 2 hours
Description

Hypotension | Mean arterial pressure

Data type

boolean

Alias
UMLS CUI [1]
C0020649
UMLS CUI [2]
C0428886
sedation agents other than remifentanyl and propofol including also catapressan, risperdal, etumine
Description

Sedatives | Exception Remifentanil | Exception Propofol | Catapres | Risperdal | Entumine

Data type

boolean

Alias
UMLS CUI [1]
C0036557
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0246631
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0033487
UMLS CUI [4]
C0699881
UMLS CUI [5]
C0592071
UMLS CUI [6]
C0950873
remifentanyl dose exceeding 0.5 µg/kg/min.
Description

Remifentanil Dosage

Data type

boolean

Alias
UMLS CUI [1,1]
C0246631
UMLS CUI [1,2]
C0178602
absence of informed consent
Description

Informed Consent Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0332197
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Similar models

Eligibility Coronary Artery Disease NCT00735631

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Coronary artery reconstruction Postoperative Period
Item
patients in the immediate post-operative phase after an coronary artery reconstruction surgery.
boolean
C1293393 (UMLS CUI [1,1])
C0032790 (UMLS CUI [1,2])
Age
Item
age >= 18 years
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
informed consent obtained before the surgery
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Kidney Failure Severe | Other Coding Classification Levels Risk | Kidney Failure | Kidney Failure, Chronic
Item
severe renal failure defined by the rifle classification levels risk, failure and end-stage kidney failure
boolean
C0035078 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C3846158 (UMLS CUI [2,1])
C0008902 (UMLS CUI [2,2])
C0441889 (UMLS CUI [2,3])
C0035647 (UMLS CUI [2,4])
C0035078 (UMLS CUI [3])
C0022661 (UMLS CUI [4])
Liver Failure Severe | Serum total bilirubin measurement | Prothrombin level
Item
severe hepatic failure defined by a bilirubin level of >= 3 mg/dl and/or a prothrombin level of < 50% before the surgery
boolean
C0085605 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1278039 (UMLS CUI [2])
C0369903 (UMLS CUI [3])
Ejection fraction decreased
Item
low ejection fraction defined as < 40%
boolean
C0743400 (UMLS CUI [1])
Age
Item
age < 18 years
boolean
C0001779 (UMLS CUI [1])
Postoperative Hemorrhage | Operative Surgical Procedure New Patient need for
Item
postoperative bleeding so that a new surgery is necessary
boolean
C0032788 (UMLS CUI [1])
C0543467 (UMLS CUI [2,1])
C0205314 (UMLS CUI [2,2])
C0686904 (UMLS CUI [2,3])
Cardiovascular accident
Item
history of cardiovascular accident (cva)
boolean
C1386002 (UMLS CUI [1])
COPD
Item
history of copd
boolean
C0024117 (UMLS CUI [1])
Age
Item
age > 75 years
boolean
C0001779 (UMLS CUI [1])
Cardiac index Postoperative
Item
postoperative cardiac index < 2.2 for more than 2 hours
boolean
C0428776 (UMLS CUI [1,1])
C0032790 (UMLS CUI [1,2])
SvO2
Item
svo2 < 60% for more than 2 hours
boolean
C0428176 (UMLS CUI [1])
Hypotension | Mean arterial pressure
Item
hypotension with a map < 60 mmhg for more than 2 hours
boolean
C0020649 (UMLS CUI [1])
C0428886 (UMLS CUI [2])
Sedatives | Exception Remifentanil | Exception Propofol | Catapres | Risperdal | Entumine
Item
sedation agents other than remifentanyl and propofol including also catapressan, risperdal, etumine
boolean
C0036557 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0246631 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0033487 (UMLS CUI [3,2])
C0699881 (UMLS CUI [4])
C0592071 (UMLS CUI [5])
C0950873 (UMLS CUI [6])
Remifentanil Dosage
Item
remifentanyl dose exceeding 0.5 µg/kg/min.
boolean
C0246631 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Informed Consent Absent
Item
absence of informed consent
boolean
C0021430 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
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