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Peak Expiratory Flow Rate for Emergency Department Management of Acute Asthma Exacerbation

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ClinicalTrials.gov Identifier: NCT03420651
Recruitment Status : Recruiting
First Posted : February 2, 2018
Last Update Posted : March 6, 2019
Sponsor:
Information provided by (Responsible Party):
Brian Driver, Minneapolis Medical Research Foundation

Tracking Information
First Submitted Date  ICMJE January 28, 2018
First Posted Date  ICMJE February 2, 2018
Last Update Posted Date March 6, 2019
Actual Study Start Date  ICMJE January 19, 2018
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2018)
Adequate control of asthma symptoms within 150 minutes [ Time Frame: 150 minutes ]
Proportion of patients reporting no or mild asthma symptoms at 150 minutes after enrollment
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03420651 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2018)
  • Hospitalization during index encounter [ Time Frame: 12 hours ]
    Rate of hospitalization in both groups directly from initial ED encounter
  • ED Length of Stay [ Time Frame: 12 hours ]
    Time elapsed from when the patient is roomed until the time the MD places discharge order, by review of the Electronic Medical record by a blinded abstractor.
  • Number of nebulized treatments with short-acting beta antagonists (SABA) [ Time Frame: 12 hours ]
    This is defined as the number of nebulized treatments received in the emergency department during the encounter, by review of the Electronic Medical record by a blinded abstractor.
  • Relapse following discharge within 72 hours [ Time Frame: 72 hours ]
    Each patient will be assessed via chart review and telephone follow up to see if they visited an ED or urgent care for asthma symptoms during the 72 hour time frame. Rates of relapse will be compared between the two treatment arms.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Peak Expiratory Flow Rate for Emergency Department Management of Acute Asthma Exacerbation
Official Title  ICMJE Peak Expiratory Flow Rate (PEFR) for Emergency Department Management of Acute Asthma
Brief Summary Patients presenting to the emergency department with acute asthma exacerbation will be assigned to peak-expiratory flow rate (PEFR) guided management and non-PEFR guided management.
Detailed Description

It is common practice to use peak-expiratory flow rate (PEFR) as an indicator of severity in patients that present with acute asthma exacerbation. There is, however, little data supporting this practice.

A recent Canadian 20 site prospective observational cohort study of 805 ED patients with acute asthma exacerbation concluded PEFR was not useful in predicting need for hospitalization or relapse following discharge.

As this was a cohort observational study, the conclusions that can be drawn are limited by the lack of randomization and control; it is necessary to conduct a randomized controlled trial to quantify how much time is expended caring for these patients, and gather safety data.

This is important because no studies have quantified differences in resource utilization based on PEFR-guided management compared to non-PEFR-guided management. It is possible physicians following PEFR-guided management use comparatively more resources, such as nebulizer treatments and hospitalization, in order to treat low PEFR values in patients they would have otherwise discharged based on clinical judgement alone. If outcomes are not affected by non-PEFR-guided management, it may reduce resource utilization to avoid using PEFR-guided management.

The investigators seek to determine if PEFR-based management and non-PEFR-based management perform similarly in guiding ED management of acute asthma exacerbations. Specifically, they seek to determine if the proportion of patients with no or mild asthma symptoms at 150 minutes after enrollment arrival is similar in the two groups.

At 150 minutes, it is expected that approximately 80% of patients will have no or mild asthma symptoms in both groups. When comparing the proportion of patients between the two groups, a confidence interval less than 20% wide (10% on either side of the point estimate) is desired. Therefore, goal enrollment is 110 patients per group.

This study will only include patients who are discharged from the ED. Patients who are enrolled and then eventually admitted to the hospital will be tabulated but excluded from the analysis.

Statistical analysis will compare the difference in the proportion of patients who achieve the primary outcome between groups, with the associated 95% confidence interval. Secondary outcomes will be presented descriptively; depending on the final distribution of the data, the investigators will present the means or medians of the data with the associated difference in mean/median with the associated 95% confidence intervals

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Masking Description:
When patients are randomized to the non-peak flow guided therapy, physicians are blinded to the peak flow values
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • Other: Peak Expiratory Flow Rate (PEFR)
    PEFR values and the National Asthma Prevention and Education Program guidelines will be used by providers in the management of these patients.
  • Other: Standard Clinical Judgement
    Providers will use physical exam and standard clinical judgement to guide management.
Study Arms  ICMJE
  • Experimental: PEFR Guided Management
    Peak Expiratory Flow Rate (PEFR) Patients in this group will perform PEFR testing every 30 minutes and this data along with the National Asthma Prevention and Education Program guidelines will be considered by primary ED medical providers in the management of this group.
    Intervention: Other: Peak Expiratory Flow Rate (PEFR)
  • Experimental: Non-PEFR Guided Management
    Standard Clinical Judgement Patients in this group will receive management based on primary medical provider's clinical judgement.
    Intervention: Other: Standard Clinical Judgement
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 28, 2018)
220
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2020
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Presumed diagnosis of asthma, requiring at least 2 nebulized albuterol treatments
  • Presenting with acute asthma exacerbation defined as acute or subacute episodes of progressively worsening shortness of breath, cough, wheezing, and chest tightness, or some combination of these symptoms
  • Start of enrollment process must occur within 15 minutes of being roomed in the ED
  • Working phone number and willingness to be contacted at least 72 hours following encounter

Exclusion Criteria:

  • Prisoner or in custody
  • Pregnant
  • Known diagnosis of COPD
  • Co-morbid medical conditions that patient is seeking treatment for concurrently
  • Non-English speaking
  • Unable to provide informed consent
  • In the resuscitation bay or on non-invasive positive pressure ventilation (NPPV)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 55 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Audrey Hendrickson 612-873-7448 audrey.hendrickson@hcmed.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03420651
Other Study ID Numbers  ICMJE 17-4459
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Brian Driver, Minneapolis Medical Research Foundation
Study Sponsor  ICMJE Minneapolis Medical Research Foundation
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Minneapolis Medical Research Foundation
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP