Sputum Induction by Physiotherapy and Hypertonic Saline Techniques in Asthmatic Children

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03136042
• Other study ID #: UNICID
• Status: Completed
• Phase: N/A
• Start date: January 15, 2016
• Est. completion date: July 5, 2018

Study information

• Verified date: April 2019
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: July 5, 2018
• Est. primary completion date: August 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Other:
• physiotherapy techniques
oscillating positive expiratory pressure during nonstop 5 minutes. After that more five minutes to a forced expiratory technique
• hypertonic saline 3%
four nebulizations with 3% hypertonic saline, the aerosol was generated by an ultrasonic nebulizer
• saline + physiotherapy maneuvers
sputum induction by hypertonic saline at 3% for seven minutes. And more five minutes under physiotherapists maneuvers

Locations

Country	Name	City	State
Brazil	Children's Institute of the Clinical Hospital of University of Sao Paulo	São Paulo	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Universidade Cidade de Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sputum induction by hypertonic saline 3% associated with physiotherapists maneuvers	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.	3 days
Primary	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	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