Eligibility Respiratory Failure NCT00647361

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StudyEvent: Eligibility
1. Eligibility Respiratory Failure NCT00647361

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

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])

Exclusion Criteria

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])

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])

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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Eligibility Respiratory Failure NCT00647361