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Sputum Induction by Physiotherapy and Hypertonic Saline Techniques in Asthmatic Children

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03136042
Enrollment
33
Registered
2017-05-02
Start date
2016-01-15
Completion date
2018-07-05
Last updated
2019-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

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.

Interventions

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

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

OTHERsaline + physiotherapy maneuvers

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

Sponsors

Universidade Cidade de Sao Paulo
CollaboratorOTHER
University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
7 Years to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Sputum induction by physiotherapists maneuvers3 dayschildren 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

MeasureTime frameDescription
Sputum induction by hypertonic saline 3%3 dayschildren 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

MeasureTime frameDescription
Sputum induction by hypertonic saline 3% associated with physiotherapists maneuvers3 daysFirstly, 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.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026