ID

38503

Description

Study of Non-Invasive Regional Oxygen Saturations in Pediatric Patients Undergoing Cardiac Catheterization; ODM derived from: https://clinicaltrials.gov/show/NCT00939224

Link

https://clinicaltrials.gov/show/NCT00939224

Keywords

Versions (1)
  1. 10/22/19 10/22/19 -
Copyright Holder

See clinicaltrials.gov

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October 22, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Cardiovascular Disease NCT00939224

English

Eligibility Cardiovascular Disease NCT00939224

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
the subject is male or female;
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
the subject is of any racial or ethnic group;
Description

Racial group Any | Ethnic group Any

Data type

boolean

Alias
UMLS CUI [1,1]
C0034510
UMLS CUI [1,2]
C1552551
UMLS CUI [2,1]
C0015031
UMLS CUI [2,2]
C1552551
the subject is between 0 days and 12 years of age;
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
is less than 40 kg;
Description

Body Weight

Data type

boolean

Alias
UMLS CUI [1]
C0005910
the subject is scheduled for a cardiac catheterization for treatment or diagnosis of a cardiovascular disease;
Description

Cardiac Catheterization Scheduled | Treatment Cardiovascular Disease | Diagnosis Cardiovascular Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0018795
UMLS CUI [1,2]
C0205539
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0007222
UMLS CUI [3,1]
C0011900
UMLS CUI [3,2]
C0007222
the scheduled cardiac catheterization includes catheter placements in the central venous circulation and central arterial circulation, or catheter placement in the central venous circulation with a pre-existing arterial catheter;
Description

Cardiac Catheterization Procedure Scheduled | Catheter placement Blood Circulation Venous Central | Arterial catheter Pre-existing | Catheter placement Blood Circulation Arterial Central

Data type

boolean

Alias
UMLS CUI [1,1]
C0018795
UMLS CUI [1,2]
C0205539
UMLS CUI [2,1]
C0883301
UMLS CUI [2,2]
C0005775
UMLS CUI [2,3]
C0348013
UMLS CUI [2,4]
C0205099
UMLS CUI [3,1]
C0581447
UMLS CUI [3,2]
C2347662
UMLS CUI [4,1]
C0883301
UMLS CUI [4,2]
C0005775
UMLS CUI [4,3]
C0221464
UMLS CUI [4,4]
C0205099
the subject is american society anesthesiologist (asa) status 1 through 4; and
Description

ASA physical status classification

Data type

boolean

Alias
UMLS CUI [1]
C0450990
the subject's legally authorized representative has given written informed consent to participate in the study and, when appropriate, the subject has given assent to participate.
Description

Informed Consent Patient Representative | Study Subject Assent Participation

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0030701
UMLS CUI [2,1]
C0681850
UMLS CUI [2,2]
C1879749
UMLS CUI [2,3]
C0679823
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
is greater than twelve (12) years of age;
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
has pre-existing allergies to adhesive tapes or adhesives on neonatal ecg pads;
Description

Adhesive tape allergy Pre-existing | Other Coding

Data type

boolean

Alias
UMLS CUI [1,1]
C0948721
UMLS CUI [1,2]
C2347662
UMLS CUI [2]
C3846158
has pre-existing skin condition at the site where the nonin cerebral oximeter sensor will be placed (e.g., eczema, dermatitis);
Description

Skin condition Pre-existing Cerebral oximeter sensor Site | Eczema | Dermatitis

Data type

boolean

Alias
UMLS CUI [1,1]
C1719933
UMLS CUI [1,2]
C2347662
UMLS CUI [1,3]
C3878733
UMLS CUI [1,4]
C1515974
UMLS CUI [2]
C0013595
UMLS CUI [3]
C0011603
has craniofacial disease preventing application of the sensor to the forehead;
Description

Disease craniofacial | Application Cerebral oximeter sensor Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0596392
UMLS CUI [2,1]
C0185125
UMLS CUI [2,2]
C3878733
UMLS CUI [2,3]
C0332196
has sickle cell anemia or other hemoglobinopathy;
Description

Anemia, Sickle Cell | Hemoglobinopathy

Data type

boolean

Alias
UMLS CUI [1]
C0002895
UMLS CUI [2]
C0019045
has disease of the cerebrovasculature including the jugular or carotid vessels;
Description

Cerebrovascular Disorder Including Jugular veins | Cerebrovascular Disorder Including Carotid vessels

Data type

boolean

Alias
UMLS CUI [1,1]
C0007820
UMLS CUI [1,2]
C0332257
UMLS CUI [1,3]
C0022427
UMLS CUI [2,1]
C0007820
UMLS CUI [2,2]
C0332257
UMLS CUI [2,3]
C1508554
was previously on ecmo involving the carotid or jugular vessels that could have resulted in disease or ligation;
Description

ECMO Involving Carotid vessels | ECMO Involving Jugular veins | With result Disease | With result Ligation

Data type

boolean

Alias
UMLS CUI [1,1]
C0015357
UMLS CUI [1,2]
C1314939
UMLS CUI [1,3]
C1508554
UMLS CUI [2,1]
C0015357
UMLS CUI [2,2]
C1314939
UMLS CUI [2,3]
C0022427
UMLS CUI [3,1]
C0332294
UMLS CUI [3,2]
C0012634
UMLS CUI [4,1]
C0332294
UMLS CUI [4,2]
C0023690
is not able to be in a supine position with cardiac catheterization laboratory table angle zero degrees with a neutral neck position at zero degrees rotation;
Description

Supine Position Unable | Cardiac Catheterization Procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0038846
UMLS CUI [1,2]
C1299582
UMLS CUI [2]
C0018795
has acute neurological injury (seizure, stroke, encephalopathy, meningoencephalitis currently or within the past 10 days), or a structural brain lesion (eg, arteriovenous malformation, cyst) in the optical field beneath the sensor;
Description

Trauma, Nervous System | Seizures | Cerebrovascular accident | Encephalopathy | Meningoencephalitis | Brain lesion structural | Arteriovenous malformation | Cyst

Data type

boolean

Alias
UMLS CUI [1]
C0751792
UMLS CUI [2]
C0036572
UMLS CUI [3]
C0038454
UMLS CUI [4]
C0085584
UMLS CUI [5]
C0025309
UMLS CUI [6,1]
C0221505
UMLS CUI [6,2]
C0678594
UMLS CUI [7]
C0003857
UMLS CUI [8]
C0010709
has an emergency, life-threatening condition (american society of anesthesiologists physical status 5 or 6) impacting the ability to obtain informed consent;
Description

Emergency Life threatening illness | ASA physical status classification | Impact Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0013956
UMLS CUI [1,2]
C3846017
UMLS CUI [2]
C0450990
UMLS CUI [3,1]
C4049986
UMLS CUI [3,2]
C0021430
or has another condition, which in the opinion of the principal investigator would not be suitable for participation in the study.
Description

Condition Study Subject Participation Status Inappropriate

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1548788
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Similar models

Eligibility Cardiovascular Disease NCT00939224

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender
Item
the subject is male or female;
boolean
C0079399 (UMLS CUI [1])
Racial group Any | Ethnic group Any
Item
the subject is of any racial or ethnic group;
boolean
C0034510 (UMLS CUI [1,1])
C1552551 (UMLS CUI [1,2])
C0015031 (UMLS CUI [2,1])
C1552551 (UMLS CUI [2,2])
Age
Item
the subject is between 0 days and 12 years of age;
boolean
C0001779 (UMLS CUI [1])
Body Weight
Item
is less than 40 kg;
boolean
C0005910 (UMLS CUI [1])
Cardiac Catheterization Scheduled | Treatment Cardiovascular Disease | Diagnosis Cardiovascular Disease
Item
the subject is scheduled for a cardiac catheterization for treatment or diagnosis of a cardiovascular disease;
boolean
C0018795 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0007222 (UMLS CUI [2,2])
C0011900 (UMLS CUI [3,1])
C0007222 (UMLS CUI [3,2])
Cardiac Catheterization Procedure Scheduled | Catheter placement Blood Circulation Venous Central | Arterial catheter Pre-existing | Catheter placement Blood Circulation Arterial Central
Item
the scheduled cardiac catheterization includes catheter placements in the central venous circulation and central arterial circulation, or catheter placement in the central venous circulation with a pre-existing arterial catheter;
boolean
C0018795 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
C0883301 (UMLS CUI [2,1])
C0005775 (UMLS CUI [2,2])
C0348013 (UMLS CUI [2,3])
C0205099 (UMLS CUI [2,4])
C0581447 (UMLS CUI [3,1])
C2347662 (UMLS CUI [3,2])
C0883301 (UMLS CUI [4,1])
C0005775 (UMLS CUI [4,2])
C0221464 (UMLS CUI [4,3])
C0205099 (UMLS CUI [4,4])
ASA physical status classification
Item
the subject is american society anesthesiologist (asa) status 1 through 4; and
boolean
C0450990 (UMLS CUI [1])
Informed Consent Patient Representative | Study Subject Assent Participation
Item
the subject's legally authorized representative has given written informed consent to participate in the study and, when appropriate, the subject has given assent to participate.
boolean
C0021430 (UMLS CUI [1,1])
C0030701 (UMLS CUI [1,2])
C0681850 (UMLS CUI [2,1])
C1879749 (UMLS CUI [2,2])
C0679823 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Age
Item
is greater than twelve (12) years of age;
boolean
C0001779 (UMLS CUI [1])
Adhesive tape allergy Pre-existing | Other Coding
Item
has pre-existing allergies to adhesive tapes or adhesives on neonatal ecg pads;
boolean
C0948721 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C3846158 (UMLS CUI [2])
Skin condition Pre-existing Cerebral oximeter sensor Site | Eczema | Dermatitis
Item
has pre-existing skin condition at the site where the nonin cerebral oximeter sensor will be placed (e.g., eczema, dermatitis);
boolean
C1719933 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C3878733 (UMLS CUI [1,3])
C1515974 (UMLS CUI [1,4])
C0013595 (UMLS CUI [2])
C0011603 (UMLS CUI [3])
Disease craniofacial | Application Cerebral oximeter sensor Excluded
Item
has craniofacial disease preventing application of the sensor to the forehead;
boolean
C0012634 (UMLS CUI [1,1])
C0596392 (UMLS CUI [1,2])
C0185125 (UMLS CUI [2,1])
C3878733 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
Anemia, Sickle Cell | Hemoglobinopathy
Item
has sickle cell anemia or other hemoglobinopathy;
boolean
C0002895 (UMLS CUI [1])
C0019045 (UMLS CUI [2])
Cerebrovascular Disorder Including Jugular veins | Cerebrovascular Disorder Including Carotid vessels
Item
has disease of the cerebrovasculature including the jugular or carotid vessels;
boolean
C0007820 (UMLS CUI [1,1])
C0332257 (UMLS CUI [1,2])
C0022427 (UMLS CUI [1,3])
C0007820 (UMLS CUI [2,1])
C0332257 (UMLS CUI [2,2])
C1508554 (UMLS CUI [2,3])
ECMO Involving Carotid vessels | ECMO Involving Jugular veins | With result Disease | With result Ligation
Item
was previously on ecmo involving the carotid or jugular vessels that could have resulted in disease or ligation;
boolean
C0015357 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C1508554 (UMLS CUI [1,3])
C0015357 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
C0022427 (UMLS CUI [2,3])
C0332294 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
C0332294 (UMLS CUI [4,1])
C0023690 (UMLS CUI [4,2])
Supine Position Unable | Cardiac Catheterization Procedure
Item
is not able to be in a supine position with cardiac catheterization laboratory table angle zero degrees with a neutral neck position at zero degrees rotation;
boolean
C0038846 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0018795 (UMLS CUI [2])
Trauma, Nervous System | Seizures | Cerebrovascular accident | Encephalopathy | Meningoencephalitis | Brain lesion structural | Arteriovenous malformation | Cyst
Item
has acute neurological injury (seizure, stroke, encephalopathy, meningoencephalitis currently or within the past 10 days), or a structural brain lesion (eg, arteriovenous malformation, cyst) in the optical field beneath the sensor;
boolean
C0751792 (UMLS CUI [1])
C0036572 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C0085584 (UMLS CUI [4])
C0025309 (UMLS CUI [5])
C0221505 (UMLS CUI [6,1])
C0678594 (UMLS CUI [6,2])
C0003857 (UMLS CUI [7])
C0010709 (UMLS CUI [8])
Emergency Life threatening illness | ASA physical status classification | Impact Informed Consent
Item
has an emergency, life-threatening condition (american society of anesthesiologists physical status 5 or 6) impacting the ability to obtain informed consent;
boolean
C0013956 (UMLS CUI [1,1])
C3846017 (UMLS CUI [1,2])
C0450990 (UMLS CUI [2])
C4049986 (UMLS CUI [3,1])
C0021430 (UMLS CUI [3,2])
Condition Study Subject Participation Status Inappropriate
Item
or has another condition, which in the opinion of the principal investigator would not be suitable for participation in the study.
boolean
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
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