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

Primary Purpose

Nasal Obstruction, Exposure to Pollution

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
rhinopharyngeal retrograde clearance (RRC)
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasal Obstruction focused on measuring motorcyclist, nasal mucociliary clearance, physical therapy

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Universidade Federal de Minas Gerais
  • Faculdade de Medicina da Universidade de São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

RRC

RRC+S

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

Saccharine transit time test (STT)
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.

Secondary Outcome Measures

mucus surface property
The contact angle of nasal mucus was measured.

Full Information

First Posted
October 29, 2013
Last Updated
April 17, 2018
Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico
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1. Study Identification

Unique Protocol Identification Number
NCT01976039
Brief Title
Rhinopharyngeal Retrograde Clearance is Effective to Adequate Upper Airways Function in Adults
Official Title
The Effectiveness of Rhinopharyngeal Retrograde Clearance on the Upper Airways Symptomatology and Function in Adults
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasal Obstruction, Exposure to Pollution
Keywords
motorcyclist, nasal mucociliary clearance, physical therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RRC
Arm Type
Other
Arm Description
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.
Arm Title
RRC+S
Arm Type
Experimental
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
rhinopharyngeal retrograde clearance (RRC)
Other Intervention Name(s)
RCC+S
Intervention Description
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
Primary Outcome Measure Information:
Title
Saccharine transit time test (STT)
Description
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.
Time Frame
15 days
Secondary Outcome Measure Information:
Title
mucus surface property
Description
The contact angle of nasal mucus was measured.
Time Frame
15 days
Other Pre-specified Outcome Measures:
Title
SNOT-20
Description
A questionnaire to assess the symptoms of the nose and airways for rhinosinusitis
Time Frame
15 days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naomi K Nakagawa, PhD
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paulo HN Saldiva, PhD
Organizational Affiliation
University of Sao Paulo
Official's Role
Study Director
Facility Information:
Facility Name
Universidade Federal de Minas Gerais
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
31270-901
Country
Brazil
Facility Name
Faculdade de Medicina da Universidade de São Paulo
City
São Paulo
ZIP/Postal Code
1246-903
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
22499404
Citation
Gomes EL, Postiaux G, Medeiros DR, Monteiro KK, Sampaio LM, Costa D. Chest physical therapy is effective in reducing the clinical score in bronchiolitis: randomized controlled trial. Rev Bras Fisioter. 2012 Jun;16(3):241-7. doi: 10.1590/s1413-35552012005000018. Epub 2012 Apr 12.
Results Reference
background
PubMed Identifier
23100111
Citation
Proenca de Oliveira-Maul J, Barbosa de Carvalho H, Goto DM, Maia RM, Flo C, Barnabe V, Franco DR, Benabou S, Perracini MR, Jacob-Filho W, Saldiva PHN, Lorenzi-Filho G, Rubin BK, Nakagawa NK. Aging, diabetes, and hypertension are associated with decreased nasal mucociliary clearance. Chest. 2013 Apr;143(4):1091-1097. doi: 10.1378/chest.12-1183.
Results Reference
background
PubMed Identifier
11821764
Citation
Piccirillo JF, Merritt MG Jr, Richards ML. Psychometric and clinimetric validity of the 20-Item Sino-Nasal Outcome Test (SNOT-20). Otolaryngol Head Neck Surg. 2002 Jan;126(1):41-7. doi: 10.1067/mhn.2002.121022.
Results Reference
background
PubMed Identifier
11468003
Citation
Belda J, Parameswaran K, Keith PK, Hargreave FE. Repeatability and validity of cell and fluid-phase measurements in nasal fluid: a comparison of two methods of nasal lavage. Clin Exp Allergy. 2001 Jul;31(7):1111-5. doi: 10.1046/j.1365-2222.2001.01133.x.
Results Reference
background
PubMed Identifier
16236954
Citation
Nakagawa NK, Franchini ML, Driusso P, de Oliveira LR, Saldiva PH, Lorenzi-Filho G. Mucociliary clearance is impaired in acutely ill patients. Chest. 2005 Oct;128(4):2772-7. doi: 10.1378/chest.128.4.2772.
Results Reference
background
PubMed Identifier
17273599
Citation
Cancado JE, Braga A, Pereira LA, Arbex MA, Saldiva PH, Santos Ude P. [Clinical repercussions of exposure to atmospheric pollution]. J Bras Pneumol. 2006;32 Suppl 2:S5-11. doi: 10.1590/s1806-37132006000800003. Portuguese.
Results Reference
background
PubMed Identifier
25628001
Citation
Brant TC, Yoshida CT, Carvalho Tde S, Nicola ML, Martins JA, Braga LM, Oliveira RC, Leyton V, Andre CS, Saldiva PH, Rubin BK, Nakagawa NK. Mucociliary clearance, airway inflammation and nasal symptoms in urban motorcyclists. Clinics (Sao Paulo). 2014;69(12):867-70. doi: 10.6061/clinics/2014(12)13.
Results Reference
derived

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

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