Radioaerosol Pulmonary Deposition During Asthma Exacerbation Through Noninvasive Ventilation

Study Overview
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Brief Summary
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Despite the physiologic and clinical effects provided by coupling nebulization with noninvasive ventilation in asthma exacerbation, there are few and controversial studies reported in the literature.

Detailed Description
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Reduced work of breathing, increased oxygenation and increased in expiratory peak flow (EPF) and forced expiratory volume in the first second (FEV1) are benefits of noninvasive ventilation (NV) in the treatment of asthma. Despite these clinical improvements attributed to NV during asthma exacerbations and the well-established effects of nebulization, there are few studies in the literature coupling both therapeutic resources. In addition to this, no studies on scintigraphic analysis of radioaerosol deposition coupled with NV in asthmatics have published. A previous study was published by our group, but involved healthy subjects.

Official Title
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Analysing the Effects of Coupling Nebulization to Noninvasive Ventilation Through Pulmonary Scintigraphy on the Radioaerosol Deposition During Asthma Exacerbation

Conditions
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Asthma

Intervention / Treatment
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* Device: NV
* Other: NEB group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of moderate to severe asthma (FEV1 < 60 % of predicted values) Breathing rate > 25 bpm History of asthma for at least 1 year Duration of current asthma attack of < 7 days Reversibility of FEV1 of at least ≤ 10% after the administration of bronchodilator drugs Exclusion Criteria: Current smoker Presence of cardiopulmonary disease (COPD, pneumonia, heart failure, myocardial infarction, pneumothorax) Hyperthermia Indication of intubation and invasive mechanical ventilation; Hemodynamic instability (heart rate > 150 bpm and systolic blood pressure < 90 mmHg) Cardiac arrhythmia Changes in consciousness Pregnancy Contraindications to use NV

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NV Group<br>Performed nebulization coupled with noninvasive ventilation | Device: NV<br>* Noninvasive ventilation coupled with nebulization(Nebulization containing salbutamol (2.5mg) and ipratropium bromide (0.25mg)plus oxygen flow in 7Lpm)<br>* Other names: Interventional Group;|
| Active Comparator: NEB group<br>Performed nebulization alone. | Other: NEB group<br>* Nebulization containing salbutamol (2.5mg) and ipratropium bromide (0.25mg)plus oxygen flow in 7Lpm<br>* Other names: Control group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiopulmonary characteristics |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radioaerosol pulmonary index, radioaerosol penetration index and pulmonary clearance. |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, status asthmatics