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Completed

NCT Number: NCT03136042

Sputum Induction by Physiotherapy and Hypertonic Saline Techniques in Asthmatic Children

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

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

7 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Institute of the Clinical Hospital of University of Sao Paulo

São Paulo, 01246903, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

physiotherapy techniques

Other

oscillating positive expiratory pressure during nonstop 5 minutes. After that more five minutes to a forced expiratory technique

hypertonic saline 3%

Other

four nebulizations with 3% hypertonic saline, the aerosol was generated by an ultrasonic nebulizer

saline + physiotherapy maneuvers

Other

sputum induction by hypertonic saline at 3% for seven minutes. And more five minutes under physiotherapists maneuvers

Primary outcomes

  1. Sputum induction by physiotherapists maneuvers

    Time frame: 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 outcomes

  1. Sputum induction by hypertonic saline 3%

    Time frame: 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.

Other outcomes

  1. Sputum induction by hypertonic saline 3% associated with physiotherapists maneuvers

    Time frame: 3 days

    Firstly, children underwent sputum induction by hypertonic saline at 3% for seven minutes. Second, they underwent five minutes OPEP and then five minutes of huffing and FET, as described above.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Universidade Cidade de Sao Paulo

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
May 2, 2017
Registry last updated
Apr 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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