Effects of Rhinopharyngeal Retrograde Clearance in Children With Acute Viral Bronchiolitis

Acute Viral Bronchiolitis Clinical Trial

Official title:

Comparison Between Rhinopharyngeal Retrograde Clearance and Nasopharyngeal Aspiration in Children With Acute Viral Bronchiolitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02460614
• Other study ID #: DRR-15
• Status: Completed
• Phase: N/A
• First received: May 28, 2015
• Last updated: June 2, 2015
• Start date: March 2013
• Est. completion date: December 2013

Study information

• Verified date: June 2015
• Source: Pontificia Universidade Católica do Rio Grande do Sul
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the immediate effects of retrograde rhinopharyngeal clearance with nasopharyngeal aspiration in children admitted with acute viral bronchiolitis. The investigators selected children, up to 12 months old, admitted for acute viral bronchiolitis. Patients were divided in aspiration group (AG), submitted to nasopharyngeal aspiration, and clearance group (CG), submitted to retrograde rhinopharyngeal clearance with physiological solution (0.9%) instillation (RRC) technique. In both groups children were evaluated three times in the same day in order to verify cardiorespiratory parameters, clinical score of respiratory dysfunction and adverse effects.

Description:

Children up to 12 months old, admitted for acute viral acute viral bronchiolitis were selected. All children participating in the study should be in the first 48 hours of hospitalization. Patients were divided in aspiration group (AG), submitted to nasopharyngeal aspiration, and clearance group (CG), submitted to retrograde rhinopharyngeal clearance (RRC) technique with physiological solution (0.9%) instillation. In both groups children were evaluated three times in the same day (data collection 1 (C1) - performed early in the morning; data collecting 2 (C2) - performed in the early afternoon; and data collecting 3 (C3) - performed in the evening). In each data collection, cardiorespiratory parameters and clinical score of respiratory dysfunction were evaluated before procedures (T0), 10 minutes after (T1) and 30 minutes after (T2). Adverse effects were evaluated during the whole day of the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 12 Months

Eligibility

Inclusion Criteria:

• acute viral bronchiolitis diagnosis

• indication for hospital admission

Exclusion Criteria:

• history of lung disease related to prematurity (bronchopulmonary dysplasia)

• heart diseases

• chronic lung diseases (cystic fibrosis)

• pneumonia

• unstable hemodynamic process (ARDS or sepsis)

• subcutaneous edema

• admission to the intensive care unit

• need for mechanical ventilation or tracheostomy

• neurological diseases

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Viral Bronchiolitis
• Bronchiolitis
• Bronchiolitis, Viral

Intervention

Procedure:
• Rhinopharyngeal clearance
At the end of the expiratory time, the child's mouth was closed by the hand of the researcher (raising the lower jaw), leading the child to perform a nasal aspiration maneuver.
• Aspiration
A sterile aspiration catheter was connected to an extension and carefully introduced into the nasal cavity of the patient.

Other:
• 0.9% saline
0.9% saline consists of physiological solution and was instilled in both experimental groups.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pontificia Universidade Católica do Rio Grande do Sul

References & Publications (5)

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. Epub 2012 Apr 12. — View Citation

Jacinto CP, Gastaldi AC, Aguiar DY, Maida KD, Souza HC. Physical therapy for airway clearance improves cardiac autonomic modulation in children with acute bronchiolitis. Braz J Phys Ther. 2013 Nov-Dec;17(6):533-40. doi: 10.1590/S1413-35552012005000120. Epub 2013 Nov 1. — View Citation

Jarvis K, Pirvu D, Barbee K, Berg N, Meyer M, Gaulke L, Pate BM, Roberts C. Change to a standardized airway clearance protocol for children with bronchiolitis leads to improved care. J Pediatr Nurs. 2014 May-Jun;29(3):252-7. doi: 10.1016/j.pedn.2013.11.007. Epub 2013 Nov 27. — View Citation

Rochat I, Leis P, Bouchardy M, Oberli C, Sourial H, Friedli-Burri M, Perneger T, Barazzone Argiroffo C. Chest physiotherapy using passive expiratory techniques does not reduce bronchiolitis severity: a randomised controlled trial. Eur J Pediatr. 2012 Mar;171(3):457-62. doi: 10.1007/s00431-011-1562-y. Epub 2011 Sep 17. Erratum in: Eur J Pediatr. 2012 Mar;171(3):603. — View Citation

Sánchez Bayle M, Martín Martín R, Cano Fernández J, Martínez Sánchez G, Gómez Martín J, Yep Chullen G, García García MC. [Chest physiotherapy and bronchiolitis in the hospitalised infant. Double-blind clinical trial]. An Pediatr (Barc). 2012 Jul;77(1):5-11. doi: 10.1016/j.anpedi.2011.11.026. Epub 2012 Jan 26. Spanish. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of chest retractions as a measure of respiratory distress		30 minutes	No
Primary	Occurrence of wheezing as a measure of respiratory distress		30 minutes	No
Primary	Number of nasal bleeding events as a measure of adverse effects		1 day	Yes
Primary	Number of vomit episodes as a measure of adverse effects		1 day	Yes
Secondary	Measurement of the heart rate using an oximeter		30 minutes	No
Secondary	Measurement of the respiratory rate		30 minutes	No
Secondary	Measurement of the oxygen saturation using an oximeter		30 minutes	No
Secondary	Severity scores on the Wood clinical score		30 minutes	No