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Early High-flow Oxygen Therapy With nebuLized Beta-2-agonist Using a Vibrating Mesh for the Management of Moderate to Severe Asthma Exacerbation in the Emergency Department

RecruitingNAAges 18 Years - anyAllPoitiers University Hospital
NCT05691218 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Acute exacerbation of asthma represents an acute or sub-acute worsening in symptoms and lung function in patients with asthma. It is characterized by a progressive increase in symptoms of shortness of breath, cough, wheezing, or chest tightness. It is a common diagnosis in patients admitted in an Emergency Department for dyspnoea. Near 10 to 15% of respiratory symptoms in an ED are related to acute exacerbation of asthma. Treatment of acute exacerbation of asthma associates nebulized beta-2 agonist adrenergic with or without ipratropium bromide, oral corticosteroids and controlled oxygen therapy to maintain SpO2 between 93 and 95%. Treatment in the ED did not vary during last years, including for patients with a lack of efficacy after first line treatment, and exacerbation are always associated with a hospitalisation in 40% of adult patients and with mortality in 1% of hospitalized pati

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age equal or over 18 years * admitted in an Emergency Department with a clinical suspicion of acute exacerbation of asthma according to the Global Initiative for Asthma (GINA) criteria. * with at least one of the following criteria 60mn after a first treatment by beta-2 agonist adrenergic nebulization with 3 x 5 mg of terbutaline: * Respiratory rate over 22 breaths/min * Peak flow \< 50% of predictive normal value * SpO2 \< 95% in room air * Signs of severe asthma exacerbation (at least one criteria): Talks in word, Agitation, Sits hunched forwards, Accessory muscles in use * Free subject, without guardianship or curatorship or subordination * Patients benefiting from a Social Security scheme or benefiting from it through a third party * Informed consent signed by the patient after clear and honest information about the study Exclusion Criteria: * Acute exacerbation of asthma during the last 30 days * Clinical suspicion of acute exacerbation of asthma due to anaphylaxis, pneumothorax, pneumomediastinum, pneumonia or atelectasis. * At least ONE of the following serious signs: drowsiness, confusion, auscultatory silence * Clinical suspicion of another pathology that could explain the respiratory failure such as heart failure, laryngeal obstruction, pulmonary embolism, etc * Patients with neurological (Glasgow \< 13) or hemodynamical failure (Mean Arterial Pressure \< 65 mmHg) * contraindication to treatment with a beta-2-adrenergic agonist * History of hypersensitivity (allergy) to terbutaline or any of the constituents * Contraindication to OHD * Persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, people assessed GIR1 or GIR 2 (AGGIR grid), adults under legal protection * Pregnant or breastfeeding women, Women at age to procreate and not using effective contraception
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What it tests

  • Standard Nebulization
  • A - Vibrating mesh nebulization
  • B - Vibrating mesh nebulisation and high-flow nasal cannula heated and humidified oxygen
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Where

1 site
University Hospital of Poitiers
Poitiers, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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