Peak Expiratory Flow Rate for Emergency Department Management of Acute Asthma Exacerbation
Primary Purpose
Asthma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peak Expiratory Flow Rate (PEFR)
Standard Clinical Judgement
Sponsored by
About this trial
This is an interventional treatment trial for Asthma
Eligibility Criteria
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)
Sites / Locations
- Hennepin County Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
PEFR Guided Management
Non-PEFR Guided Management
Arm Description
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.
Standard Clinical Judgement Patients in this group will receive management based on primary medical provider's clinical judgement.
Outcomes
Primary Outcome Measures
Adequate control of asthma symptoms within 150 minutes
Proportion of patients reporting no or mild asthma symptoms at 150 minutes after enrollment
Secondary Outcome Measures
Hospitalization during index encounter
Rate of hospitalization in both groups directly from initial ED encounter
ED Length of Stay
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)
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
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.
Full Information
NCT ID
NCT03420651
First Posted
January 28, 2018
Last Updated
September 20, 2023
Sponsor
Hennepin Healthcare Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT03420651
Brief Title
Peak Expiratory Flow Rate for Emergency Department Management of Acute Asthma Exacerbation
Official Title
Peak Expiratory Flow Rate (PEFR) for Emergency Department Management of Acute Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 19, 2018 (Actual)
Primary Completion Date
November 30, 2022 (Actual)
Study Completion Date
November 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hennepin Healthcare Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Masking Description
When patients are randomized to the non-peak flow guided therapy, physicians are blinded to the peak flow values
Allocation
Randomized
Enrollment
188 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PEFR Guided Management
Arm Type
Experimental
Arm Description
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.
Arm Title
Non-PEFR Guided Management
Arm Type
Experimental
Arm Description
Standard Clinical Judgement Patients in this group will receive management based on primary medical provider's clinical judgement.
Intervention Type
Other
Intervention Name(s)
Peak Expiratory Flow Rate (PEFR)
Intervention Description
PEFR values and the National Asthma Prevention and Education Program guidelines will be used by providers in the management of these patients.
Intervention Type
Other
Intervention Name(s)
Standard Clinical Judgement
Intervention Description
Providers will use physical exam and standard clinical judgement to guide management.
Primary Outcome Measure Information:
Title
Adequate control of asthma symptoms within 150 minutes
Description
Proportion of patients reporting no or mild asthma symptoms at 150 minutes after enrollment
Time Frame
150 minutes
Secondary Outcome Measure Information:
Title
Hospitalization during index encounter
Description
Rate of hospitalization in both groups directly from initial ED encounter
Time Frame
12 hours
Title
ED Length of Stay
Description
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.
Time Frame
12 hours
Title
Number of nebulized treatments with short-acting beta antagonists (SABA)
Description
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.
Time Frame
12 hours
Title
Relapse following discharge within 72 hours
Description
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.
Time Frame
72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Hennepin County Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Peak Expiratory Flow Rate for Emergency Department Management of Acute Asthma Exacerbation
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