Clinical trial NCT02302261: Pleth Variability and Asthma Severity in Children
Official title: Using Pleth Variability to Triage Asthmatics in the Pediatric ED
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Status Asthmaticus
Keywords: Pulsus paradoxus
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: Masimo Corporation
First posted: 2014-11-26
Enrollment: 37
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Disposition from ED
timeFrame: 4 hours
Secondary outcomes:
measure: Comparison to respiratory severity score
timeFrame: 4 hours
measure: Change in disposition within 24 hours
timeFrame: 1 week
Other outcomes:
Locations:
city: New Hyde Park
country: United States
facility: Cohen Children's Medical Center of NY
state: New York
Study officials:
affiliation: Northwell Health
name: Ariel Brandwein, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arnold DH, Gebretsadik T, Minton PA, Higgins S, Hartert TV. Assessment of severity measures for acute asthma outcomes: a first step in developing an asthma clinical prediction rule. Am J Emerg Med. 2008 May;26(4):473-9. doi: 10.1016/j.ajem.2007.05.026.
citation: Arnold DH, Jenkins CA, Hartert TV. Noninvasive assessment of asthma severity using pulse oximeter plethysmograph estimate of pulsus paradoxus physiology. BMC Pulm Med. 2010 Mar 29;10:17. doi: 10.1186/1471-2466-10-17.
citation: Cannesson M, Desebbe O, Rosamel P, Delannoy B, Robin J, Bastien O, Lehot JJ. Pleth variability index to monitor the respiratory variations in the pulse oximeter plethysmographic waveform amplitude and predict fluid responsiveness in the operating theatre. Br J Anaesth. 2008 Aug;101(2):200-6. doi: 10.1093/bja/aen133. Epub 2008 Jun 2.
citation: Clark JA, Lieh-Lai M, Thomas R, Raghavan K, Sarnaik AP. Comparison of traditional and plethysmographic methods for measuring pulsus paradoxus. Arch Pediatr Adolesc Med. 2004 Jan;158(1):48-51. doi: 10.1001/archpedi.158.1.48.
citation: Frey B, Freezer N. Diagnostic value and pathophysiologic basis of pulsus paradoxus in infants and children with respiratory disease. Pediatr Pulmonol. 2001 Feb;31(2):138-43. doi: 10.1002/1099-0496(200102)31:23.0.co;2-r.
citation: Rayner J, Trespalacios F, Machan J, Potluri V, Brown G, Quattrucci LM, Jay GD. Continuous noninvasive measurement of pulsus paradoxus complements medical decision making in assessment of acute asthma severity. Chest. 2006 Sep;130(3):754-65. doi: 10.1378/chest.130.3.754.