Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2025-12-25 @ 4:49 AM
NCT ID:
NCT05691218
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05691218
Study Brief:
Protocol Section:
NCT05691218