Sputum Induction by Physiotherapy and Hypertonic Saline Techniques in Asthmatic Children

Not Applicable

Completed

• Conditions: Asthma
• Interventions: Other: saline + physiotherapy maneuvers; Other: hypertonic saline 3%; Other: physiotherapy techniques

• Registration Number: NCT03136042
• Lead Sponsor: University of Sao Paulo

Brief Summary

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

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-01-15
• Study First Submitted: 2017-04-27
• Study First Submitted QC: 2017-04-27
• Study First Posted: 2017-05-02
• Primary Completion: 2017-08-31
• Study Completion: 2018-07-05
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-15
• Last Update Posted: 2019-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• Asthmathic children used inhaled corticosteroids not associated with long-acting beta2-agonist.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
saline + physiotherapy maneuvers	saline + physiotherapy maneuvers	1 nebulizations + physiotherapy techniques
hypertonic saline 3%	hypertonic saline 3%	four nebulizations with 3% hypertonic saline.
physiotherapists maneuvers	physiotherapy techniques	physiotherapy techniques

Primary Outcome Measures

Name	Time	Method
Sputum induction by physiotherapists maneuvers	3 days	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.

Secondary Outcome Measures

Name	Time	Method
Sputum induction by hypertonic saline 3%	3 days	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.

Trial Locations

Locations (1)

Children's Institute of the Clinical Hospital of University of Sao Paulo; 🇧🇷 São Paulo, Sao Paulo, Brazil