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Pleth Variability and Asthma Severity in Children

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ClinicalTrials.gov Identifier: NCT02302261
Recruitment Status : Completed
First Posted : November 26, 2014
Last Update Posted : July 26, 2016
Sponsor:
Collaborator:
Masimo Corporation
Information provided by (Responsible Party):
Ariel Brandwein, Northwell Health

Brief Summary:
Research has shown that pleth variability can be used to assess asthma severity in children with status asthmaticus. The investigators would like to use an FDA-cleared monitor (Masimo Radical 7) which measures Pleth Variability Index (PVI) to see if the degree of PVI can be used to help triage patients who present to the pediatric ED in status asthmaticus.

Condition or disease
Status Asthmaticus

Detailed Description:

Patients with asthma have obstruction to exhalation resulting in hyperinflation of their lungs. This hyperinflation results in a phenomenon known as pulsus paradoxus in which the physiologic drop in blood pressure normally seen with inhalation is exaggerated. Studies have shown that patients with more severe asthma exacerbations (i.e. more hyperinflation) have a greater degree of pulsus paradoxus. Typically, pulsus paradoxus is measured using a sphygmomanometer, however, researchers have demonstrated that it can also accurately be measured using plethysmography, a term known as pleth variability index (PVI). Using this concept, Arnold et al (2008, 2010) showed that a greater degree of pulsus paradoxus correlates with asthma severity.

The investigators' study aims to simplify the association between PVI and asthma severity. The investigators hypothesize the following:

  1. Patients with a higher admission PVI will have a higher likelihood of being admitted to the hospital.
  2. Patients admitted to the Intensive Care Unit (PICU) will have a higher PVI than patients admitted to a floor.
  3. PVI can be accurately used to gauge response to bronchodilator/anti-inflammatory therapy.
  4. PVI is as effective as respiratory severity score in predicting asthma severity and in gauging response to bronchodilator therapy.

To do this the investigators will recruit children who present to the pediatric ED in status asthmaticus. They will be connected to a Masimo Radical 7 monitor upon admission to the ED and then again 4 hours later. In addition the investigators will calculate respiratory severity scores at those same time intervals. The investigators will then look at the disposition of the patient upon leaving the ED: discharge to home, admission to an inpatient floor or admission to the ICU.


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Study Type : Observational
Actual Enrollment : 37 participants
Time Perspective: Prospective
Official Title: Using Pleth Variability to Triage Asthmatics in the Pediatric ED
Study Start Date : January 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Group/Cohort
Status Asthmaticus
Any patient presenting to the ED with status asthmaticus.



Primary Outcome Measures :
  1. Disposition from ED [ Time Frame: 4 hours ]
    Determine whether a patient was discharged from the ED, admitted to an inpatient floor or admitted to the ICU.


Secondary Outcome Measures :
  1. Comparison to respiratory severity score [ Time Frame: 4 hours ]
    Is PVI as effective as RSS in determining asthma severity

  2. Change in disposition within 24 hours [ Time Frame: 1 week ]
    Determine if a patient who was discharged home from the ED required readmission to the ED within 1 week. Determine if a patient admitted to the floor or ICU required a change in level of care in the first 24 hours of admission.



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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
We will study patients who present to the pediatric ED at Cohen Children's Medical Center of NY with status asthmaticus.
Criteria

Inclusion Criteria:

  • Diagnosis of asthma or reactive airway disease upon leaving the ED
  • Greater than 10 kg

Exclusion Criteria:

  • Patients in whom effective pulse oximetry tracings cannot be obtained
  • Patients who are diagnosed with conditions other than asthma/reactive airway disease that are known to cause pulsus paradoxus

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02302261


Locations
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United States, New York
Cohen Children's Medical Center of NY
New Hyde Park, New York, United States, 11040
Sponsors and Collaborators
Northwell Health
Masimo Corporation
Investigators
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Principal Investigator: Ariel Brandwein, MD Northwell Health

Publications:
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Responsible Party: Ariel Brandwein, Pediatric Critical Care Fellow, Northwell Health
ClinicalTrials.gov Identifier: NCT02302261     History of Changes
Other Study ID Numbers: 14-572
First Posted: November 26, 2014    Key Record Dates
Last Update Posted: July 26, 2016
Last Verified: July 2016

Keywords provided by Ariel Brandwein, Northwell Health:
Pulsus paradoxus

Additional relevant MeSH terms:
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Status Asthmaticus
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases