Brief Summary

Asthma is a chronic respiratory disease whose goal of therapeutic, educational and preventive care is to prevent the onset of acute crisis, the most serious of which are life threatening. A general population survey shows a greater prevalence of asthma in the French West Indies compared to hexagonal France, but there is no data to our knowledge on asthma exacerbations requiring pre and intra-hospital emergency services, nor on the clinical severity or on the adequacy of the therapeutic care. Asthma exacerbations, in particular serious forms requiring immediate admission to the Emergency Department or Intensive Care Unit or leading to hospitalization, can be considered as a failure in the prevention of crisis and therefore disease control. The management of acute or subacute asthma exacerbations is however well codified in expert recommendations, renewed annually by the Global Initiative for Asthma (GINA). These recommendations specify not only the initial care, but also the strategy and modalities of return home and post-emergency follow-up. Recently the French Language Resuscitation Society (SRLF) and the French Society of Emergency Medicine (SFMU) jointly published formalized expert recommendations (RFE) on the management of asthma exacerbations (Le Conte 2019). These RFEs still remain the benchmark in France for adequate management of asthma exacerbations for adults and children. Despite these updated recommendations, field observations often show inadequate care, both in the emergency and in the post-emergency period.

Trial Health

At Risk

Trial Health Score

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

Trial has exceeded expected completion date

Enrollment

339

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Oct 2022

Geographic Reach

1 country

7 active sites

Status

unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

1.8 years study duration

First Submitted

Initial submission to the registry

January 28, 2022

Completed

26 days until next milestone

First Posted

Study publicly available on registry

February 23, 2022

Completed

8 months until next milestone

Study Start

First participant enrolled

October 10, 2022

Completed

1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2024

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2024

Completed

Last Updated

March 6, 2023

Status Verified

March 1, 2023

Enrollment Period

1.8 years

First QC Date

January 28, 2022

Last Update Submit

March 3, 2023

Conditions

Asthma

Keywords

AsthmaAsthma exacerbationAcute asthmaEmergencyAsthma treatmentFrench West Indies

Outcome Measures

Primary Outcomes (1)

To assess the adequacy of the management of acute asthma exacerbations according to the stage of severity for patients treated at the CHU of Martinique.
Percentage of patients who received adequate management by stage of severity of acute exacerbation. A tool to assist in the management of an exacerbation of asthma is described to define adequate or non-adequate management by an expert committee.
19 months

Secondary Outcomes (6)

Describe the distribution of the different stages of severity of asthma exacerbations.
19 months
Measure the hospitalization rate according to the stage of severity of the asthma exacerbations.
19 months
Measure the rate of recurrence of exacerbation (for SAMU, Emergencies, resuscitation or hospitalization) within 30 days of the initial crisis.
19 months
Measure the incidence during the study period of asthma exacerbations treated urgently at the CHU of Martinique.
19 months
Measure the proportion of patients having an exit treatment including a background treatment.
19 months
+1 more secondary outcomes

Study Arms (1)

Patients treated for asthma exacerbation

Other: Routine care

Interventions

Routine careOTHER

The investigator takes care of the patient according to the protocol in force in his department and decides on the final orientation of the patient (transfer to intensive care unit/ICU, hospitalization or home discharge). No recommendations or instructions are given to the investigators. Each investigator is free to decide on his care and the terms of transfer, hospitalization and discharge.

Patients treated for asthma exacerbation

Eligibility Criteria

Age2 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Patients treated for asthma exacerbation.

You may qualify if:

All children and adolescents (2-17 years) and adults (≥ 18 years) asthma patients.
Supported either by a team from mobile emergency and resuscitation service (SMUR) participating in the study, or by a team from the Emergency Department or possibly admitted directly to an intensive care unit participating in the study.
With an asthma exacerbation (acute asthma), the diagnostic criteria of which are as follows: history of asthma or wheezing dyspnea, exacerbation of wheezing, difficulty breathing, shortness of breath, wheezing or dry cough, and finally wheezing or silence on auscultation.
Patient or patient representative who has given oral consent for the use of their medical data for this research.

You may not qualify if:

Patient with a strong suspicion or a proven diagnosis of acute respiratory failure on chronic respiratory failure.
Patient with a strong suspicion or a proven diagnosis of acute left heart failure with wheezing (cardiac asthma) or crackling rales.
Patient with a strong suspicion or a proven diagnosis of acute febrile pneumonitis.
Patient with a strong suspicion or a proven diagnosis of acute pleurisy (reduction or elimination of vesicular murmurs, dullness of the bases or imaging).
Patient or representative of the patient who refused to agree to his participation in the study.

Contact the study team to confirm eligibility.