Pleth Variability and Asthma Severity in Children

NCT ID: NCT02302261

Last Updated: 2016-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

37 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-07-31

Brief Summary

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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

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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.

Conditions

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Status Asthmaticus

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Status Asthmaticus

Any patient presenting to the ED with status asthmaticus.

No interventions assigned to this group

Eligibility Criteria

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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
Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Masimo Corporation

INDUSTRY

Sponsor Role collaborator

Northwell Health

OTHER

Sponsor Role lead

Responsible Party

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Ariel Brandwein

Pediatric Critical Care Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ariel Brandwein, MD

Role: PRINCIPAL_INVESTIGATOR

Northwell Health

Locations

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Cohen Children's Medical Center of NY

New Hyde Park, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 18410819 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20350320 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18522935 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14706958 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11180690 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16963672 (View on PubMed)

Other Identifiers

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14-572

Identifier Type: -

Identifier Source: org_study_id

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