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

NCT ID: NCT01976039

Last Updated: 2018-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2012-08-31

Brief Summary

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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

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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.

Conditions

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Nasal Obstruction Exposure to Pollution

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type OTHER

rhinopharyngeal retrograde clearance (RRC)

Intervention Type OTHER

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

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).

Group Type EXPERIMENTAL

rhinopharyngeal retrograde clearance (RRC)

Intervention Type OTHER

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

Interventions

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rhinopharyngeal retrograde clearance (RRC)

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

Intervention Type OTHER

Other Intervention Names

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RCC+S

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role collaborator

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Naomi Kondo Nakagawa

Associate Professor of Faculdade de Medicina da Universidade de São Paulo

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Naomi K Nakagawa, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Paulo HN Saldiva, PhD

Role: STUDY_DIRECTOR

University of Sao Paulo

Locations

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Universidade Federal de Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

Site Status

Faculdade de Medicina da Universidade de São Paulo

São Paulo, , Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type BACKGROUND
PMID: 22499404 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23100111 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11821764 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11468003 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16236954 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17273599 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25628001 (View on PubMed)

Other Identifiers

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CEP-FMUSP 211-11

Identifier Type: -

Identifier Source: org_study_id

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