Pleth Variability and Asthma Severity in Children

Status Asthmaticus Clinical Trial

Official title:

Using Pleth Variability to Triage Asthmatics in the Pediatric ED

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02302261
• Other study ID #: 14-572
• Status: Completed
• Phase: N/A
• First received: November 24, 2014
• Last updated: July 25, 2016
• Start date: January 2015
• Est. completion date: July 2016

Study information

• Verified date: July 2016
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 17 Years

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Status Asthmaticus

Locations

Country	Name	City	State
United States	Cohen Children's Medical Center of NY	New Hyde Park	New York

Sponsors (2)

Lead Sponsor	Collaborator
Northwell Health	Masimo Corporation

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disposition from ED	Determine whether a patient was discharged from the ED, admitted to an inpatient floor or admitted to the ICU.	4 hours	No
Secondary	Comparison to respiratory severity score	Is PVI as effective as RSS in determining asthma severity	4 hours	No
Secondary	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.	1 week	No