ID

14462

Description

Trial of AccuPAP Device Versus Standard Nebulizer Therapy in Acute Asthma Exacerbation in Children; ODM derived from: https://clinicaltrials.gov/show/NCT02458482

Lien

https://clinicaltrials.gov/show/NCT02458482

Mots-clés

Versions (1)
  1. 16/04/2016 16/04/2016 -
Téléchargé le

16 avril 2016

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Asthma NCT02458482

Anglais

Eligibility Asthma NCT02458482

1 Formulaires  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02458482
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
investigators will enroll children ages 6 - 17 years (inclusive) with a previous diagnosis of asthma who present in an acute exacerbation to the pediatric emergency department.
Description

Age | Prior diagnosis Asthma | Exacerbation of asthma | Pediatric Emergency Department

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0332132
UMLS CUI [2,2]
C0004096
UMLS CUI [3]
C0349790
UMLS CUI [4]
C4035225
patients will be evaluated using the acute asthma intensity research score (aairs) which has been validated at vanderbilt university medical center and is currently the standard of care when triaging patients with asthma.
Description

Asthma Score | Academic Medical Centers

Type de données

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C0449820
UMLS CUI [2]
C0000872
an included patient's severity of current exacerbation must be qualified using the aairs and fall in the moderate category of 7 to 11 points.
Description

Exacerbation of moderate persistent asthma

Type de données

boolean

Alias
UMLS CUI [1]
C3873345
patients who have received nebulized bronchodilator medications at either a referring facility or at home will be included.
Description

Bronchodilator Agents Bronchilator inhaler

Type de données

boolean

Alias
UMLS CUI [1,1]
C0006280
UMLS CUI [1,2]
C0350310
patients who present from a referring facility or primary care physician (pcp) and have received systemic corticosteroids (scs) within one hour of initial aairs scoring will also be included.
Description

systemic steroids | Primary Care Physicians

Type de données

boolean

Alias
UMLS CUI [1]
C2825233
UMLS CUI [2]
C0033131
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
exclusion criteria will include the following: other medical conditions contributing to respiratory distress (e.g., pneumonia, cystic fibrosis, anaphylaxis),
Description

Disease | Respiratory distress | Pneumonia | Cystic Fibrosis | anaphylaxis

Type de données

boolean

Alias
UMLS CUI [1]
C0012634
UMLS CUI [2]
C0476273
UMLS CUI [3]
C0032285
UMLS CUI [4]
C0010674
UMLS CUI [5]
C0002792
developmental delay or any impedance to following basic accupap use instructions,
Description

Developmental delay | Disability | Compliance behavior Limited

Type de données

boolean

Alias
UMLS CUI [1]
C0424605
UMLS CUI [2]
C0231170
UMLS CUI [3,1]
C1321605
UMLS CUI [3,2]
C0439801
any condition precluding a patient from receiving beta-agonist therapy (ie-
Description

Disease | Unable Therapeutic procedure Adrenergic beta-Agonists

Type de données

boolean

Alias
UMLS CUI [1]
C0012634
UMLS CUI [2,1]
C1299582
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C0001644
predisposition to supraventricular tachycardia).
Description

Predisposition Supraventricular tachycardia

Type de données

boolean

Alias
UMLS CUI [1,1]
C0220898
UMLS CUI [1,2]
C0039240
patients with a history of spontaneous pneumothorax, recent facial, oral or skull surgery/trauma, history of esophageal surgery, known or suspected tympanic membrane rupture or other middle ear pathology, acute sinusitis, epistaxis, active hemoptysis or nausea will be excluded as these are contraindications for accupap use.
Description

Spontaneous pneumothorax | facial surgery | Oral Surgical Procedures | cranial surgery | Operation on esophagus | Tympanic Membrane Perforation | Disorder of middle ear | Acute sinusitis | Epistaxis | Hemoptysis | Nausea

Type de données

boolean

Alias
UMLS CUI [1]
C0149781
UMLS CUI [2]
C2224535
UMLS CUI [3]
C0524861
UMLS CUI [4]
C2224798
UMLS CUI [5]
C0192259
UMLS CUI [6]
C0206504
UMLS CUI [7]
C0271428
UMLS CUI [8]
C0149512
UMLS CUI [9]
C0014591
UMLS CUI [10]
C0019079
UMLS CUI [11]
C0027497
patients who have received additional adjunctive therapies beyond repeated saba and atrovent nebulizers or those who have received scs greater than 1 hour prior to initial ed evaluation, those who have received intravenous magnesium sulfate infusion, or subcutaneous terbutaline or epinephrine will be excluded.
Description

Adjuvant therapy | Adrenergic beta-2 Receptor Agonists | Nebulizer therapy | systemic steroids | Magnesium Sulfate Injectable Product | Terbutaline | Epinephrine

Type de données

boolean

Alias
UMLS CUI [1]
C0677850
UMLS CUI [2]
C2936789
UMLS CUI [3]
C0199447
UMLS CUI [4]
C2825233
UMLS CUI [5]
C0721528
UMLS CUI [6]
C0039542
UMLS CUI [7]
C0014563
those patients whose parents are require a translator for consent will also be excluded (ie, exclusively spanish speaking or other non-english speaking families/patients). the justification for this exclusion is that patients with respiratory distress often need rapid initiation of treatment and the delay that may be caused by coordination efforts required in order to obtain a translator for study consent and explanation may delay care for these patients and result in adverse outcomes that may potentially result in harm.
Description

Non-English speaking | Able to speak Spanish Language | Respiratory distress | Compliance behavior Limited

Type de données

boolean

Alias
UMLS CUI [1]
C1546417
UMLS CUI [2,1]
C0564215
UMLS CUI [2,2]
C0037750
UMLS CUI [3]
C0476273
UMLS CUI [4,1]
C1321605
UMLS CUI [4,2]
C0439801
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Similar models

Eligibility Asthma NCT02458482

1 Formulaires
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02458482
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Age | Prior diagnosis Asthma | Exacerbation of asthma | Pediatric Emergency Department
Item
investigators will enroll children ages 6 - 17 years (inclusive) with a previous diagnosis of asthma who present in an acute exacerbation to the pediatric emergency department.
boolean
C0001779 (UMLS CUI [1])
C0332132 (UMLS CUI [2,1])
C0004096 (UMLS CUI [2,2])
C0349790 (UMLS CUI [3])
C4035225 (UMLS CUI [4])
Asthma Score | Academic Medical Centers
Item
patients will be evaluated using the acute asthma intensity research score (aairs) which has been validated at vanderbilt university medical center and is currently the standard of care when triaging patients with asthma.
boolean
C0004096 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
C0000872 (UMLS CUI [2])
Exacerbation of moderate persistent asthma
Item
an included patient's severity of current exacerbation must be qualified using the aairs and fall in the moderate category of 7 to 11 points.
boolean
C3873345 (UMLS CUI [1])
Bronchodilator Agents Bronchilator inhaler
Item
patients who have received nebulized bronchodilator medications at either a referring facility or at home will be included.
boolean
C0006280 (UMLS CUI [1,1])
C0350310 (UMLS CUI [1,2])
systemic steroids | Primary Care Physicians
Item
patients who present from a referring facility or primary care physician (pcp) and have received systemic corticosteroids (scs) within one hour of initial aairs scoring will also be included.
boolean
C2825233 (UMLS CUI [1])
C0033131 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Disease | Respiratory distress | Pneumonia | Cystic Fibrosis | anaphylaxis
Item
exclusion criteria will include the following: other medical conditions contributing to respiratory distress (e.g., pneumonia, cystic fibrosis, anaphylaxis),
boolean
C0012634 (UMLS CUI [1])
C0476273 (UMLS CUI [2])
C0032285 (UMLS CUI [3])
C0010674 (UMLS CUI [4])
C0002792 (UMLS CUI [5])
Developmental delay | Disability | Compliance behavior Limited
Item
developmental delay or any impedance to following basic accupap use instructions,
boolean
C0424605 (UMLS CUI [1])
C0231170 (UMLS CUI [2])
C1321605 (UMLS CUI [3,1])
C0439801 (UMLS CUI [3,2])
Disease | Unable Therapeutic procedure Adrenergic beta-Agonists
Item
any condition precluding a patient from receiving beta-agonist therapy (ie-
boolean
C0012634 (UMLS CUI [1])
C1299582 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0001644 (UMLS CUI [2,3])
Predisposition Supraventricular tachycardia
Item
predisposition to supraventricular tachycardia).
boolean
C0220898 (UMLS CUI [1,1])
C0039240 (UMLS CUI [1,2])
Spontaneous pneumothorax | facial surgery | Oral Surgical Procedures | cranial surgery | Operation on esophagus | Tympanic Membrane Perforation | Disorder of middle ear | Acute sinusitis | Epistaxis | Hemoptysis | Nausea
Item
patients with a history of spontaneous pneumothorax, recent facial, oral or skull surgery/trauma, history of esophageal surgery, known or suspected tympanic membrane rupture or other middle ear pathology, acute sinusitis, epistaxis, active hemoptysis or nausea will be excluded as these are contraindications for accupap use.
boolean
C0149781 (UMLS CUI [1])
C2224535 (UMLS CUI [2])
C0524861 (UMLS CUI [3])
C2224798 (UMLS CUI [4])
C0192259 (UMLS CUI [5])
C0206504 (UMLS CUI [6])
C0271428 (UMLS CUI [7])
C0149512 (UMLS CUI [8])
C0014591 (UMLS CUI [9])
C0019079 (UMLS CUI [10])
C0027497 (UMLS CUI [11])
Adjuvant therapy | Adrenergic beta-2 Receptor Agonists | Nebulizer therapy | systemic steroids | Magnesium Sulfate Injectable Product | Terbutaline | Epinephrine
Item
patients who have received additional adjunctive therapies beyond repeated saba and atrovent nebulizers or those who have received scs greater than 1 hour prior to initial ed evaluation, those who have received intravenous magnesium sulfate infusion, or subcutaneous terbutaline or epinephrine will be excluded.
boolean
C0677850 (UMLS CUI [1])
C2936789 (UMLS CUI [2])
C0199447 (UMLS CUI [3])
C2825233 (UMLS CUI [4])
C0721528 (UMLS CUI [5])
C0039542 (UMLS CUI [6])
C0014563 (UMLS CUI [7])
Non-English speaking | Able to speak Spanish Language | Respiratory distress | Compliance behavior Limited
Item
those patients whose parents are require a translator for consent will also be excluded (ie, exclusively spanish speaking or other non-english speaking families/patients). the justification for this exclusion is that patients with respiratory distress often need rapid initiation of treatment and the delay that may be caused by coordination efforts required in order to obtain a translator for study consent and explanation may delay care for these patients and result in adverse outcomes that may potentially result in harm.
boolean
C1546417 (UMLS CUI [1])
C0564215 (UMLS CUI [2,1])
C0037750 (UMLS CUI [2,2])
C0476273 (UMLS CUI [3])
C1321605 (UMLS CUI [4,1])
C0439801 (UMLS CUI [4,2])
Retour au début de la page 

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