Rhinopharyngeal Retrograde Clearance is Effective to Adequate Upper Airways Function in Adults

April 17, 2018 updated by: Naomi Kondo Nakagawa, University of Sao Paulo

The Effectiveness of Rhinopharyngeal Retrograde Clearance on the Upper Airways Symptomatology and Function in Adults

Professionals working in polluted areas may present increased clinical airways symptoms and dysfunction. Rhinopharyngeal retrograde clearance (RRC) has been used to improve mucus clearance in infants with bronchitis and bronchiolitis, and instillation the nasal cavity with saline has been used to reduce nasal inflammation in rhinitis and sinusopathies. The aim of this study was to assess the effects of RRC and RCC combined with saline (RRC+S) on nasal mucociliary clearance (MCC), mucus surface property, cellularity and airways symptoms in professional motorcyclists.

Study Overview

Detailed Description

Male motorcyclists (mean age 36 years) were recruited and randomly assigned to RRC or RRC+S. Subjects were assessed at baseline and 15 days after interventions for saccharin test, mucus contact angle, cellularity in nasal lavage and airways symptoms with the use of SNOT-20 questionnaire. Data were analyzed by two-way ANOVA for repeated measures with Bonferroni´s correction. A passive monitoring-system of nitrogen dioxide was used to assess the individual air pollution exposure along the study period. The association between nitrogen dioxide and the airways outcomes was analyzed by Spearman correlation test.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • São Paulo, Brazil, 1246-903
        • Faculdade de Medicina da Universidade de Sao Paulo
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 31270-901
        • Universidade Federal de Minas Gerais

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Professional motorcyclists aged 18 years to 45 years
  • Minimum of one year in that occupation
  • Agreement with the written informed consent

Exclusion Criteria:

  • Smokers
  • Inability to understand and to follow commands
  • Previous nasal surgery
  • Respiratory infection in the previous 30 days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: RRC
rhinopharyngeal retrograde clearance (RRC) isolated: First patient sits in a chair. Second: patient inhales air deeply and exhales making noise and vibration in the upper airway to facilitate swalling. Third patients finishes with another deep inhalation. This technique is new, simple to use and with no cost. No need of any material or equipment.
The rhinopharyngeal retrograde clearance is a respiratory physical therapy technique that uses a forced inspiratory maneuver to clear the nasopharynx with the aid of saline instillation
Other Names:
  • RCC+S
Experimental: RRC+S
retrograde rhinopharyngeal retrograde clearance combined with saline instillation (RRC+S): patient sits in a chair and inhaled air and make noise and vibrate the upper airway at the same instills saline into the nare to facilitate nose washing and swalling. This technique is new, simple to use and with low cost (only saline).
The rhinopharyngeal retrograde clearance is a respiratory physical therapy technique that uses a forced inspiratory maneuver to clear the nasopharynx with the aid of saline instillation
Other Names:
  • RCC+S

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Saccharine transit time test (STT)
Time Frame: 15 days
To measure nasal mucociliary clearance. Subjects were asked to report the first perception of a sweet taste after 25 mg of saccharine powder was deposited in the free airflow nostril.
15 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mucus surface property
Time Frame: 15 days
The contact angle of nasal mucus was measured.
15 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
SNOT-20
Time Frame: 15 days
A questionnaire to assess the symptoms of the nose and airways for rhinosinusitis
15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Naomi K Nakagawa, PhD, University of Sao Paulo
  • Study Director: Paulo HN Saldiva, PhD, University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

October 29, 2013

First Submitted That Met QC Criteria

November 4, 2013

First Posted (Estimate)

November 5, 2013

Study Record Updates

Last Update Posted (Actual)

April 19, 2018

Last Update Submitted That Met QC Criteria

April 17, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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