NCT02302261

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 26, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

July 26, 2016

Status Verified

July 1, 2016

Enrollment Period

1.5 years

First QC Date

November 24, 2014

Last Update Submit

July 25, 2016

Conditions

Status Asthmaticus

Keywords

Pulsus paradoxus

Outcome Measures

Primary Outcomes (1)

  • Disposition from ED

    Determine whether a patient was discharged from the ED, admitted to an inpatient floor or admitted to the ICU.

    4 hours

Secondary Outcomes (2)

  • Comparison to respiratory severity score

    4 hours

  • Change in disposition within 24 hours

    1 week

Study Arms (1)

Status Asthmaticus

Any patient presenting to the ED with status asthmaticus.

Eligibility Criteria

AgeUp to 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • Diagnosis of asthma or reactive airway disease upon leaving the ED
  • Greater than 10 kg

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cohen Children's Medical Center of NY

New Hyde Park, New York, 11040, United States

Location

Related 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.

    PMID: 18410819BACKGROUND

  • 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.

    PMID: 20350320BACKGROUND

  • 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.

    PMID: 18522935BACKGROUND

  • 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.

    PMID: 14706958BACKGROUND

  • 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.

    PMID: 11180690BACKGROUND

  • 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.

    PMID: 16963672BACKGROUND

MeSH Terms

Conditions

Status Asthmaticus

Condition Hierarchy (Ancestors)

AsthmaBronchial DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Ariel Brandwein, MD

    Northwell Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pediatric Critical Care Fellow

Study Record Dates

First Submitted

November 24, 2014

First Posted

November 26, 2014

Study Start

January 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

July 26, 2016

Record last verified: 2016-07

Locations

US(1)