Pilot Study of Asthma Diagnosis Through Peak Flows
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 100
- Primary Endpoint
- Diagnosis of asthma
Study Overview
Brief Summary
The guidelines indicate the possibility of diagnosing asthma through peak flow. This recommendation being the result of expert consensus, but the evidence is limited and contradictory. The aim of the present study is to assess whether the diagnosis of asthma through peak flow is not inferior to that of spirometry with bronchodilator test, which is the gold standard test. This is a pilot study to validate a diagnostic test. Its location is an urban health centre (CAP Sant Llàtzer of the Consorci Sanitari de Terrassa). Participation will be offered to all adult patients (18 years of age or older) who are suspected of having an asthma diagnosis. On the one hand, the reversibility will be determined by performing the peak flow test in the center with the administration of 4 puffs of salbutamol. On the other hand, PBD spirometry will be performed to complete the study and diagnosis of the patient. Peak flow is faster, cheaper, simpler, more accessible and safer for professionals in the context of an airbone pandemic.
Detailed Description
The pandemic has had a strong impact on healthcare quality standards in Catalonia. Prioritization at the primary level of immediate care over scheduled care has led to a decrease in continuity in patient care.
Asthma is a common treatable disease and exacerbations are preventable with proper staging and treatment if necessary. During the present pandemic, the ability to diagnose it through the test of choice (spirometry with bronchodilator test) has been compromised, taking into account the risks arising for health personnel to perform. This fact has conditioned that in the pandemic context it is recommended to limit its use as much as possible.
These reasons led to the suspension of spirometry at the beginning of the pandemic and later, although they have been restarted with the indicated filters to improve safety for patients and professionals, it has not been possible to restore normally for issues arising from the care pressure associated with the pandemic.
When the investigators reviewed the clinical guidelines, they specify that the diagnosis of asthma can also be made by measuring the maximum expiratory flow (PEF) with the peak flow. The measurement of PEF is simple, objective, non-invasive, and adds value to daily clinical practice, helping to define severity and contributing to patient self-management of the disease. The guidelines recommend that the diagnosis through peak flow is a degree of evidence C as the studies are very small samples and therefore the recommendation is based more on the consensus of experts than on the studies available.
However, these guidelines propose two alternative techniques: variability and reversibility.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Suspition of asthma, not yet confirmed.
Exclusion Criteria
- •No acceptance.
Outcomes
Primary Outcomes
Diagnosis of asthma
Time Frame: 2 months
Diagnosis of asthma through reversivility in peak flow compared to spirometry with bronchodilator test.
Secondary Outcomes
- Preference(2 months)
- Predisposition(2 months)
- Ratios(2 months)
- Acceptation(2 months)
- Sensitivity and specifity(2 months)
Investigators
Joan Torras Borrell
Family Medicine, Principal Investigator, Clinical mentor
Consorci Sanitari de Terrassa