- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02302261
Pleth Variability and Asthma Severity in Children
Using Pleth Variability to Triage Asthmatics in the Pediatric ED
Study Overview
Status
Conditions
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:
- 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
Enrollment (Actual)
Contacts and Locations
Study Locations
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New York
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New Hyde Park, New York, United States, 11040
- Cohen Children's Medical Center of NY
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Status Asthmaticus
Any patient presenting to the ED with status asthmaticus.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disposition from ED
Time Frame: 4 hours
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Determine whether a patient was discharged from the ED, admitted to an inpatient floor or admitted to the ICU.
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4 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison to respiratory severity score
Time Frame: 4 hours
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Is PVI as effective as RSS in determining asthma severity
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4 hours
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Change in disposition within 24 hours
Time Frame: 1 week
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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.
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1 week
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ariel Brandwein, MD, Northwell Health
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-572
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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