Sputum Induction by Physiotherapy and Hypertonic Saline Techniques in Asthmatic Children

Study Overview
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Brief Summary
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This study evaluated whether physiotherapy is efficient in sputum induction and in evaluation of pulmonary inflammation in asthmatic children.

Detailed Description
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The hypertonic saline is a traditional technique to collect induced sputum, it´s safe and viable in asthmatic children, as well as the technique of sputum induction and processing has been standardized for schoolchildren. Sometimes researchers have difficulties to obtain induced sputum in stable patients and it´s possible to use physiotherapy maneuvers to induced sputum. The manouvers are safe for adult and children asthmatics stable. This study aimed to evaluate the effectiveness to collect induced sputum by physiotherapy maneuvers.

Official Title
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A Randomized Crossover Study of Sputum Induction by Physiotherapy and Hypertonic Saline Techniques in Asthmatic Children.

Conditions
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Asthma

Intervention / Treatment
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* Other: physiotherapy techniques
* Other: hypertonic saline 3%
* Other: saline + physiotherapy maneuvers


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Asthmathic children used inhaled corticosteroids not associated with long-acting beta2-agonist. Exclusion Criteria: Asthmathic children to diagnose with other chronic pulmonary pathologies (cystic fibrosis, ciliary dyskinesia, bronchiolitis obliterans, and bronchopulmonary dysplasia) before study, no significant pulmonary pathologies, incapacity to realize pulmonary function and insufficient sample.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 18 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: Parallel Assignment
Interventional Model Description: Patients were randomized in first visits into crossover techniques: (i) hypertonic saline (3%) - HS technique; (ii) physiotherapy techniques (oscillatory positive expiratory pressure, forced expiration and acceleration of expiratory flow) - P technique; (iii) hypertonic saline + physiotherapy techniques - HSP technique. All children attended three visits and 90 samples were collected. All patients underwent induced sputum and pulmonary function before and after bronchodilator.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: physiotherapists maneuvers<br>physiotherapy techniques | Other: physiotherapy techniques<br>* oscillating positive expiratory pressure during nonstop 5 minutes. After that more five minutes to a forced expiratory technique<br>|
| Active Comparator: hypertonic saline 3%<br>four nebulizations with 3% hypertonic saline. | Other: hypertonic saline 3%<br>* four nebulizations with 3% hypertonic saline, the aerosol was generated by an ultrasonic nebulizer<br>|
| Active Comparator: saline + physiotherapy maneuvers<br>1 nebulizations + physiotherapy techniques | Other: saline + physiotherapy maneuvers<br>* sputum induction by hypertonic saline at 3% for seven minutes. And more five minutes under physiotherapists maneuvers<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sputum induction by physiotherapists maneuvers | children were seated in a position where the thorax was inclined forwards by 45°, they were instructed to perform calm and long exhalations by oscillating positive expiratory pressure (OPEP) during nonstop 5 minutes holding a Flutter® (Scandipharm, Birmingham, AL, EUA). After that, children were positioned in supine zero degree and underwent for more five minutes to a forced exhalation with the open mouth/glottis (huffing) associated to acceleration by forced expiratory technique (FET), performed by the therapist by positioning a hand on xiphoid process and the other in the manubrium sternum. | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sputum induction by hypertonic saline 3% | children received until four nebulizations with 3% hypertonic saline, the aerosol was generated by an ultrasonic nebulizer (Ultraneb 99; DeVilbiss, Somerset, PA) each challenge was monitored with PEF between nebulizations. | 3 days |