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



Status:Recruiting
Conditions:Asthma, Hospital
Therapuetic Areas:Pulmonary / Respiratory Diseases, Other
Healthy:No
Age Range:16 - 55
Updated:3/8/2019
Start Date:January 19, 2018
End Date:January 2020
Contact:Audrey Hendrickson
Email:audrey.hendrickson@hcmed.org
Phone:612-873-7448

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Peak Expiratory Flow Rate (PEFR) for Emergency Department Management of Acute Asthma

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.

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

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)
We found this trial at
1
site
Minneapolis, Minnesota 55414
Phone: 612-873-9528
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Minneapolis, MN
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