High-flow oxygen therapy with nebulized medication for asthma attacks in the emergency department
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
This study tests if using high-flow oxygen therapy with a special nebulizer can help people having a bad asthma attack feel better compared to standard treatments in the emergency department.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Poitiers University Hospital Academic / other |
| Locations | 1 site (Poitiers, France) |
| Trial ID | NCT05691218 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of high-flow oxygen therapy combined with nebulized beta-2-agonists using a vibrating mesh nebulizer for patients experiencing moderate to severe asthma exacerbations in the emergency department. The study aims to improve treatment outcomes by comparing standard nebulization methods with the innovative vibrating mesh approach. Patients will be monitored for respiratory rate, peak flow, and oxygen saturation to assess the efficacy of the interventions. The goal is to provide a more effective treatment option for acute asthma exacerbations.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who present to the emergency department with acute asthma exacerbations and meet specific clinical criteria.
Not a fit: Patients who have experienced an acute asthma exacerbation in the last 30 days may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved management of asthma exacerbations, reducing hospitalizations and enhancing patient outcomes.
How similar studies have performed: While the use of nebulized beta-2-agonists is standard, the combination with high-flow oxygen therapy using vibrating mesh nebulizers is a novel approach that has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Poitiers, France
- University Hospital of Poitiers — Poitiers, France, France (Recruiting)
Study contacts
- Principal investigator: Nicolas MARJANOVIC, MD PHD — CHU Poitiers
- Study coordinator: Nicolas MARJANOVIC, MD PHD
- Email: nicolas.marjanovic@chu-poitiers.fr
- Phone: 0549441873
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.