ID

31814

Beschrijving

Mechanical Ventilation Controlled by the Electrical Activity of the Patient's Diaphragm - Effects on Cardiac Performance; ODM derived from: https://clinicaltrials.gov/show/NCT00647361

Link

https://clinicaltrials.gov/show/NCT00647361

Trefwoorden

Versies (1)
  1. 30-09-18 30-09-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

30 september 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Respiratory Failure NCT00647361

Engels

Eligibility Respiratory Failure NCT00647361

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male or female patients aged 18 - 85 years (extremes included)
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
2. mechanical ventilation (tracheally intubated or tracheotomized)
Beschrijving

Mechanical ventilation | Intubation, tracheal | Tracheotomy

Datatype

boolean

Alias
UMLS CUI [1]
C0199470
UMLS CUI [2]
C0021932
UMLS CUI [3]
C0040591
3. relevant interaction between the ventilator and the cardiac performance defined as an inspiratory deflection in central venous pressure or pulmonary diastolic pressure of
Beschrijving

Interaction Ventilator Cardiac function | Abnormal central venous pressure Inspiratory | Pulmonary diastolic pressure

Datatype

boolean

Alias
UMLS CUI [1,1]
C1704675
UMLS CUI [1,2]
C0042497
UMLS CUI [1,3]
C0232164
UMLS CUI [2,1]
C0277895
UMLS CUI [2,2]
C0004048
UMLS CUI [3]
C0428644
≥ 5 mmhg
Beschrijving

ID.4

Datatype

boolean

1. in 10 patients with impaired cardiac performance defined as either
Beschrijving

Patients Quantity | Decreased cardiac function

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1265611
UMLS CUI [2]
C0232166
a left ventricular ejection fraction of < 40% and/or
Beschrijving

Left ventricular ejection fraction

Datatype

boolean

Alias
UMLS CUI [1]
C0428772
treatment with dobutamine ≥2μg/kg/min, or adrenaline ≥ 3μg/kg/min and/or
Beschrijving

Dobutamine U/kg/min | Adrenaline U/kg/min

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012963
UMLS CUI [1,2]
C1532636
UMLS CUI [2,1]
C0014563
UMLS CUI [2,2]
C1532636
a cardiac index of ≤ 2.2 l•min-1•m2 and/or
Beschrijving

Cardiac index

Datatype

boolean

Alias
UMLS CUI [1]
C0428776
a pulmonary artery occlusion pressure (paop) ≥ 18 mmhg
Beschrijving

Pulmonary artery occlusion pressure

Datatype

boolean

Alias
UMLS CUI [1]
C0034094
2. in 10 patients with a history of chronic obstructive pulmonary disease (copd) and delayed triggering-on / cycling-off and/or evidence for wasted inspiratory efforts as evidenced by:
Beschrijving

Patients Quantity | Chronic Obstructive Airway Disease | Other Coding | Inspiration Abnormal

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1265611
UMLS CUI [2]
C0024117
UMLS CUI [3]
C3846158
UMLS CUI [4,1]
C0004048
UMLS CUI [4,2]
C0205161
limitation of expiratory air flow and intrinsic peep as assessed by observation of the expiratory air flow curve and measurement of the airway pressure during an expiratory hold maneuver and/or
Beschrijving

Expiratory Airflow Limited | Positive End-Expiratory Pressure Limited | Expiratory Airflow Observation | Airway pressure Measurement | Other Coding

Datatype

boolean

Alias
UMLS CUI [1,1]
C2713474
UMLS CUI [1,2]
C0439801
UMLS CUI [2,1]
C0032740
UMLS CUI [2,2]
C0439801
UMLS CUI [3,1]
C2713474
UMLS CUI [3,2]
C0302523
UMLS CUI [4,1]
C0597386
UMLS CUI [4,2]
C0242485
UMLS CUI [5]
C3846158
excessive activation of inspiratory and / or expiratory muscles as assessed by observation of the patient
Beschrijving

Inspiratory muscle training Excessive | Expiratory Muscle Strength Training Excessive

Datatype

boolean

Alias
UMLS CUI [1,1]
C0454511
UMLS CUI [1,2]
C0442802
UMLS CUI [2,1]
C4086280
UMLS CUI [2,2]
C0442802
4. presence of a pulmonary artery catheter and an arterial pressure line
Beschrijving

Pulmonary artery catheter | Arterial pressure Catheter

Datatype

boolean

Alias
UMLS CUI [1]
C3882333
UMLS CUI [2,1]
C0232108
UMLS CUI [2,2]
C0085590
5. subject itself or its next of kin has given written informed consent
Beschrijving

Informed Consent | Informed Consent Patient's next of kin

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0421492
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patient is less than 18 years or more than 80 years of age
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
2. the attending physician refuses to allow enrollment
Beschrijving

Enrollment Refused Attending physician

Datatype

boolean

Alias
UMLS CUI [1,1]
C1516879
UMLS CUI [1,2]
C1705116
UMLS CUI [1,3]
C1320929
3. the patient refuses informed consent
Beschrijving

Informed Consent Refused

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1705116
4. next of kin is unavailable or refuses informed consent
Beschrijving

Patient's next of kin Unavailable | Patient's next of kin Informed Consent Refused

Datatype

boolean

Alias
UMLS CUI [1,1]
C0421492
UMLS CUI [1,2]
C0686905
UMLS CUI [2,1]
C0421492
UMLS CUI [2,2]
C0021430
UMLS CUI [2,3]
C1705116
5. pregnant or breast-feeding female. a pregnancy test will be performed in all female patients less than 60 years of age. the patient will not be enrolled in the study if the test result is positive.
Beschrijving

Pregnancy | Pregnancy test positive | Breast Feeding | Gender Age Pregnancy Test

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0240802
UMLS CUI [3]
C0006147
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0001779
UMLS CUI [4,3]
C0032976
6. any contraindication to insertion/exchange a nasogastric tube, including (but not limited to): severe oropharyngeal malformation or bleeding; esophageal varices, tumor, infection, stenosis, or rupture
Beschrijving

Medical contraindication Nasogastric tube procedures | Malformation Oropharyngeal Severe | Hemorrhage Oropharyngeal Severe | Esophageal Varices | Esophageal Neoplasms | Oesophageal infection | Esophageal Stenosis | Rupture of esophagus

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0812428
UMLS CUI [2,1]
C0302142
UMLS CUI [2,2]
C0521367
UMLS CUI [2,3]
C0205082
UMLS CUI [3,1]
C0019080
UMLS CUI [3,2]
C0521367
UMLS CUI [3,3]
C0205082
UMLS CUI [4]
C0014867
UMLS CUI [5]
C0014859
UMLS CUI [6]
C0851979
UMLS CUI [7]
C0014866
UMLS CUI [8]
C0281839
7. presence or suspicion of diaphragm injury
Beschrijving

Injury of diaphragm | Suspicion Injury of diaphragm

Datatype

boolean

Alias
UMLS CUI [1]
C0434014
UMLS CUI [2,1]
C0242114
UMLS CUI [2,2]
C0434014
8. hemophilia or other severe bleeding disorder
Beschrijving

Hemophilia | Blood Coagulation Disorder Severe

Datatype

boolean

Alias
UMLS CUI [1]
C0684275
UMLS CUI [2,1]
C0005779
UMLS CUI [2,2]
C0205082
9. presence or suspicion of a central nervous system (cns) disorder, including (but not limited to): cns infarction, bleeding, tumor, or infection
Beschrijving

CNS disorder | Suspicion CNS disorder | Central Nervous System Infarction | Central nervous system haemorrhage | Central Nervous System Neoplasms | Central Nervous System Infection

Datatype

boolean

Alias
UMLS CUI [1]
C0007682
UMLS CUI [2,1]
C0242114
UMLS CUI [2,2]
C0007682
UMLS CUI [3,1]
C3714787
UMLS CUI [3,2]
C0021308
UMLS CUI [4]
C3267019
UMLS CUI [5]
C0085136
UMLS CUI [6]
C0007684
10. history of heart and/or lung transplantation
Beschrijving

Heart Transplantation | Lung Transplantation

Datatype

boolean

Alias
UMLS CUI [1]
C0018823
UMLS CUI [2]
C0024128
11. any mechanical cardiac assist device (including intraaortic balloon pump)
Beschrijving

Heart-Assist Device Mechanical | Intra-aortic balloon pump

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018831
UMLS CUI [1,2]
C0443254
UMLS CUI [2]
C0702122
12. any contraindication to reduce sedation or to stop neuromuscular blockage in order to allow spontaneous breathing
Beschrijving

Medical contraindication Sedation Reducing | Medical contraindication Stop Neuromuscular blockade

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0344106
UMLS CUI [1,3]
C0392756
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C2746065
UMLS CUI [2,3]
C0234119
13. the patient needs to be ventilated with a mode of mv controlling for tidal volume or for airway pressure as per attending physician.
Beschrijving

Patient need for Ventilation | Minute ventilation Controlling Tidal Volume | Minute ventilation Controlling Airway pressure

Datatype

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0554804
UMLS CUI [2,1]
C1301655
UMLS CUI [2,2]
C2587213
UMLS CUI [2,3]
C0040210
UMLS CUI [3,1]
C1301655
UMLS CUI [3,2]
C2587213
UMLS CUI [3,3]
C0428719
14. severe hemodynamic instability as judged by the attending physician
Beschrijving

Hemodynamic instability

Datatype

boolean

Alias
UMLS CUI [1]
C0948268
15. planned or anticipated intervention within the study period necessitating either transfer out of the icu or requiring prolonged interaction with the patient.
Beschrijving

Intervention Planned | Intervention Anticipated

Datatype

boolean

Alias
UMLS CUI [1,1]
C0184661
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C0184661
UMLS CUI [2,2]
C3840775
16. a fraction of inspired oxygen (fio2) of > 0.8
Beschrijving

FIO2 - Inspired fraction of oxygen

Datatype

boolean

Alias
UMLS CUI [1]
C0428648
17. the patient currently participates in another interventional clinical trial
Beschrijving

Study Subject Participation Status | Interventional Study

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C3274035
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Similar models

Eligibility Respiratory Failure NCT00647361

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. male or female patients aged 18 - 85 years (extremes included)
boolean
C0001779 (UMLS CUI [1])
Mechanical ventilation | Intubation, tracheal | Tracheotomy
Item
2. mechanical ventilation (tracheally intubated or tracheotomized)
boolean
C0199470 (UMLS CUI [1])
C0021932 (UMLS CUI [2])
C0040591 (UMLS CUI [3])
Interaction Ventilator Cardiac function | Abnormal central venous pressure Inspiratory | Pulmonary diastolic pressure
Item
3. relevant interaction between the ventilator and the cardiac performance defined as an inspiratory deflection in central venous pressure or pulmonary diastolic pressure of
boolean
C1704675 (UMLS CUI [1,1])
C0042497 (UMLS CUI [1,2])
C0232164 (UMLS CUI [1,3])
C0277895 (UMLS CUI [2,1])
C0004048 (UMLS CUI [2,2])
C0428644 (UMLS CUI [3])
ID.4
Item
≥ 5 mmhg
boolean
Patients Quantity | Decreased cardiac function
Item
1. in 10 patients with impaired cardiac performance defined as either
boolean
C0030705 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0232166 (UMLS CUI [2])
Left ventricular ejection fraction
Item
a left ventricular ejection fraction of < 40% and/or
boolean
C0428772 (UMLS CUI [1])
Dobutamine U/kg/min | Adrenaline U/kg/min
Item
treatment with dobutamine ≥2μg/kg/min, or adrenaline ≥ 3μg/kg/min and/or
boolean
C0012963 (UMLS CUI [1,1])
C1532636 (UMLS CUI [1,2])
C0014563 (UMLS CUI [2,1])
C1532636 (UMLS CUI [2,2])
Cardiac index
Item
a cardiac index of ≤ 2.2 l•min-1•m2 and/or
boolean
C0428776 (UMLS CUI [1])
Pulmonary artery occlusion pressure
Item
a pulmonary artery occlusion pressure (paop) ≥ 18 mmhg
boolean
C0034094 (UMLS CUI [1])
Patients Quantity | Chronic Obstructive Airway Disease | Other Coding | Inspiration Abnormal
Item
2. in 10 patients with a history of chronic obstructive pulmonary disease (copd) and delayed triggering-on / cycling-off and/or evidence for wasted inspiratory efforts as evidenced by:
boolean
C0030705 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0024117 (UMLS CUI [2])
C3846158 (UMLS CUI [3])
C0004048 (UMLS CUI [4,1])
C0205161 (UMLS CUI [4,2])
Expiratory Airflow Limited | Positive End-Expiratory Pressure Limited | Expiratory Airflow Observation | Airway pressure Measurement | Other Coding
Item
limitation of expiratory air flow and intrinsic peep as assessed by observation of the expiratory air flow curve and measurement of the airway pressure during an expiratory hold maneuver and/or
boolean
C2713474 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0032740 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C2713474 (UMLS CUI [3,1])
C0302523 (UMLS CUI [3,2])
C0597386 (UMLS CUI [4,1])
C0242485 (UMLS CUI [4,2])
C3846158 (UMLS CUI [5])
Inspiratory muscle training Excessive | Expiratory Muscle Strength Training Excessive
Item
excessive activation of inspiratory and / or expiratory muscles as assessed by observation of the patient
boolean
C0454511 (UMLS CUI [1,1])
C0442802 (UMLS CUI [1,2])
C4086280 (UMLS CUI [2,1])
C0442802 (UMLS CUI [2,2])
Pulmonary artery catheter | Arterial pressure Catheter
Item
4. presence of a pulmonary artery catheter and an arterial pressure line
boolean
C3882333 (UMLS CUI [1])
C0232108 (UMLS CUI [2,1])
C0085590 (UMLS CUI [2,2])
Informed Consent | Informed Consent Patient's next of kin
Item
5. subject itself or its next of kin has given written informed consent
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0421492 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Age
Item
1. patient is less than 18 years or more than 80 years of age
boolean
C0001779 (UMLS CUI [1])
Enrollment Refused Attending physician
Item
2. the attending physician refuses to allow enrollment
boolean
C1516879 (UMLS CUI [1,1])
C1705116 (UMLS CUI [1,2])
C1320929 (UMLS CUI [1,3])
Informed Consent Refused
Item
3. the patient refuses informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1705116 (UMLS CUI [1,2])
Patient's next of kin Unavailable | Patient's next of kin Informed Consent Refused
Item
4. next of kin is unavailable or refuses informed consent
boolean
C0421492 (UMLS CUI [1,1])
C0686905 (UMLS CUI [1,2])
C0421492 (UMLS CUI [2,1])
C0021430 (UMLS CUI [2,2])
C1705116 (UMLS CUI [2,3])
Pregnancy | Pregnancy test positive | Breast Feeding | Gender Age Pregnancy Test
Item
5. pregnant or breast-feeding female. a pregnancy test will be performed in all female patients less than 60 years of age. the patient will not be enrolled in the study if the test result is positive.
boolean
C0032961 (UMLS CUI [1])
C0240802 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C0079399 (UMLS CUI [4,1])
C0001779 (UMLS CUI [4,2])
C0032976 (UMLS CUI [4,3])
Medical contraindication Nasogastric tube procedures | Malformation Oropharyngeal Severe | Hemorrhage Oropharyngeal Severe | Esophageal Varices | Esophageal Neoplasms | Oesophageal infection | Esophageal Stenosis | Rupture of esophagus
Item
6. any contraindication to insertion/exchange a nasogastric tube, including (but not limited to): severe oropharyngeal malformation or bleeding; esophageal varices, tumor, infection, stenosis, or rupture
boolean
C1301624 (UMLS CUI [1,1])
C0812428 (UMLS CUI [1,2])
C0302142 (UMLS CUI [2,1])
C0521367 (UMLS CUI [2,2])
C0205082 (UMLS CUI [2,3])
C0019080 (UMLS CUI [3,1])
C0521367 (UMLS CUI [3,2])
C0205082 (UMLS CUI [3,3])
C0014867 (UMLS CUI [4])
C0014859 (UMLS CUI [5])
C0851979 (UMLS CUI [6])
C0014866 (UMLS CUI [7])
C0281839 (UMLS CUI [8])
Injury of diaphragm | Suspicion Injury of diaphragm
Item
7. presence or suspicion of diaphragm injury
boolean
C0434014 (UMLS CUI [1])
C0242114 (UMLS CUI [2,1])
C0434014 (UMLS CUI [2,2])
Hemophilia | Blood Coagulation Disorder Severe
Item
8. hemophilia or other severe bleeding disorder
boolean
C0684275 (UMLS CUI [1])
C0005779 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
CNS disorder | Suspicion CNS disorder | Central Nervous System Infarction | Central nervous system haemorrhage | Central Nervous System Neoplasms | Central Nervous System Infection
Item
9. presence or suspicion of a central nervous system (cns) disorder, including (but not limited to): cns infarction, bleeding, tumor, or infection
boolean
C0007682 (UMLS CUI [1])
C0242114 (UMLS CUI [2,1])
C0007682 (UMLS CUI [2,2])
C3714787 (UMLS CUI [3,1])
C0021308 (UMLS CUI [3,2])
C3267019 (UMLS CUI [4])
C0085136 (UMLS CUI [5])
C0007684 (UMLS CUI [6])
Heart Transplantation | Lung Transplantation
Item
10. history of heart and/or lung transplantation
boolean
C0018823 (UMLS CUI [1])
C0024128 (UMLS CUI [2])
Heart-Assist Device Mechanical | Intra-aortic balloon pump
Item
11. any mechanical cardiac assist device (including intraaortic balloon pump)
boolean
C0018831 (UMLS CUI [1,1])
C0443254 (UMLS CUI [1,2])
C0702122 (UMLS CUI [2])
Medical contraindication Sedation Reducing | Medical contraindication Stop Neuromuscular blockade
Item
12. any contraindication to reduce sedation or to stop neuromuscular blockage in order to allow spontaneous breathing
boolean
C1301624 (UMLS CUI [1,1])
C0344106 (UMLS CUI [1,2])
C0392756 (UMLS CUI [1,3])
C1301624 (UMLS CUI [2,1])
C2746065 (UMLS CUI [2,2])
C0234119 (UMLS CUI [2,3])
Patient need for Ventilation | Minute ventilation Controlling Tidal Volume | Minute ventilation Controlling Airway pressure
Item
13. the patient needs to be ventilated with a mode of mv controlling for tidal volume or for airway pressure as per attending physician.
boolean
C0686904 (UMLS CUI [1,1])
C0554804 (UMLS CUI [1,2])
C1301655 (UMLS CUI [2,1])
C2587213 (UMLS CUI [2,2])
C0040210 (UMLS CUI [2,3])
C1301655 (UMLS CUI [3,1])
C2587213 (UMLS CUI [3,2])
C0428719 (UMLS CUI [3,3])
Hemodynamic instability
Item
14. severe hemodynamic instability as judged by the attending physician
boolean
C0948268 (UMLS CUI [1])
Intervention Planned | Intervention Anticipated
Item
15. planned or anticipated intervention within the study period necessitating either transfer out of the icu or requiring prolonged interaction with the patient.
boolean
C0184661 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0184661 (UMLS CUI [2,1])
C3840775 (UMLS CUI [2,2])
FIO2 - Inspired fraction of oxygen
Item
16. a fraction of inspired oxygen (fio2) of > 0.8
boolean
C0428648 (UMLS CUI [1])
Study Subject Participation Status | Interventional Study
Item
17. the patient currently participates in another interventional clinical trial
boolean
C2348568 (UMLS CUI [1])
C3274035 (UMLS CUI [2])
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