Pleth Variability and Asthma Severity in Children
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02302261|
Recruitment Status : Completed
First Posted : November 26, 2014
Last Update Posted : July 26, 2016
|Condition or disease|
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:
- Patients with a higher admission PVI will have a higher likelihood of being admitted to the hospital.
- Patients admitted to the Intensive Care Unit (PICU) will have a higher PVI than patients admitted to a floor.
- PVI can be accurately used to gauge response to bronchodilator/anti-inflammatory therapy.
- 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.
|Study Type :||Observational|
|Actual Enrollment :||37 participants|
|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|
Any patient presenting to the ED with status asthmaticus.
- 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.
- Comparison to respiratory severity score [ Time Frame: 4 hours ]Is PVI as effective as RSS in determining asthma severity
- 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.
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
|United States, New York|
|Cohen Children's Medical Center of NY|
|New Hyde Park, New York, United States, 11040|
|Principal Investigator:||Ariel Brandwein, MD||Northwell Health|