An observational study in Status Asthmaticus, sponsored by Northwell Health. Completed at 1 site in United States. Open to participants aged Up to 17 Years. Per ClinicalTrials.gov, last updated 2016-07-26.
Sponsored by Northwell Health · Observational
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.
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:
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.
39 studies on the registry are indexed under Status Asthmaticus; 2 are open to participants now.
Browse Status Asthmaticus studies →Northwell Health is the lead sponsor of 463 studies on the registry; 109 are open to participants now.
Of its 40 completed or terminated interventional studies of FDA-regulated products, 20 (50%) have results posted.
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We will study patients who present to the pediatric ED at Cohen Children's Medical Center of NY with status asthmaticus.
Exclusion Criteria:
Any patient presenting to the ED with status asthmaticus.
Disposition from ED
Determine whether a patient was discharged from the ED, admitted to an inpatient floor or admitted to the ICU.
Time frame: 4 hours
Comparison to respiratory severity score
Is PVI as effective as RSS in determining asthma severity
Time frame: 4 hours
Change in disposition within 24 hours
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.
Time frame: 1 week
This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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