AzTrials
AzTrials

Acute Viral BronchiolitisNCT02460614

Effects of Rhinopharyngeal Retrograde Clearance in Children With Acute Viral Bronchiolitis

A study testing Rhinopharyngeal clearance, Aspiration and 0.9% saline in people with Acute Viral Bronchiolitis, run by Pontificia Universidade Católica do Rio Grande do Sul.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages Up to 12 months
Conditions the study is for
Acute Viral Bronchiolitis
What is being tested?
Rhinopharyngeal clearance, Aspiration and 0.9% saline
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
No sites listed yet
Study dates
Mar 2013to Dec 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 12 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • acute viral bronchiolitis diagnosis
  • indication for hospital admission

Who cannot join

  • 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
Show all 9Show fewer
  • admission to the intensive care unit
  • need for mechanical ventilation or tracheostomy
  • neurological diseases

About this study

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

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.

Read the detailed 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.

Being tested
Rhinopharyngeal clearance, Aspiration, 0.9% saline
Keywords
bronchiolitis, respiratory physiotherapy, pediatrics, rhinopharyngeal clearance
Medical subject headings
Bronchiolitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rhinopharyngeal clearanceProcedure or surgery

    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.

  • AspirationProcedure or surgery

    A sterile aspiration catheter was connected to an extension and carefully introduced into the nasal cavity of the patient.

  • 0.9% salineOther

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

Study groups in NCT02460614
Study groupRoleWhat they receive
Rhinopharyngeal clearance + 0.9% salineExperimentalThe retrograde rhinopharyngeal clearance (RRC) is based on the inspiratory reflex that follows a slow and prolonged expiration (passive exhalation technique performed using a slow thoracic-abdominal compression that begins at the end of a spontaneous exhalation and continues until the expiratory reserve volume). 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. The instillation of saline (0.9%) preceded this step, resulting in the inhalation of the substance during the forced inspiration, contributing to the nasopharyngeal clearance.
Receives: Procedure: Rhinopharyngeal clearance; Other: 0.9% saline
Aspiration + 0.9% salineActive comparatorNasopharyngeal aspiration consisted in the introduction of a catheter that, by using negative pressure (vacuum), promotes the suction of secretion from the airways. In order to do that, a sterile aspiration catheter was connected to an extension and carefully introduced into the nasal cavity of the patient. The saline instillation of 0.9% was used for humidification before the procedure.
Receives: Procedure: Aspiration; Other: 0.9% saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of chest retractions as a measure of respiratory distress

    Measured: 30 minutes

  2. Occurrence of wheezing as a measure of respiratory distress

    Measured: 30 minutes

  3. Number of nasal bleeding events as a measure of adverse effects

    Measured: 1 day

  4. Number of vomit episodes as a measure of adverse effects

    Measured: 1 day

Secondary outcomes (4)

  1. Measurement of the heart rate using an oximeter

    Measured: 30 minutes

  2. Measurement of the respiratory rate

    Measured: 30 minutes

  3. Measurement of the oxygen saturation using an oximeter

    Measured: 30 minutes

  4. Severity scores on the Wood clinical score

    Measured: 30 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2015 (estimated)
  2. Study startMar 2013
  3. Primary completionOct 2013
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02460614
Sponsor's protocol ID
DRR-15
Status last verified
Jun 2015
First submitted
28 May 2015
Last updated
3 Jun 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 22499404

  • 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.

    PubMed 21927808

  • Sanchez Bayle M, Martin Martin R, Cano Fernandez J, Martinez Sanchez G, Gomez Martin J, Yep Chullen G, Garcia Garcia 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.

    PubMed 22281403

  • 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.

    PubMed 24271093

  • 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.

    PubMed 24333327

  • Roque-Figuls M, Gine-Garriga M, Granados Rugeles C, Perrotta C, Vilaro J. Chest physiotherapy for acute bronchiolitis in paediatric patients between 0 and 24 months old. Cochrane Database Syst Rev. 2023 Apr 3;4(4):CD004873. doi: 10.1002/14651858.CD004873.pub6.

    PubMed 37010196

  • Gomes GR, Calvete FP, Rosito GF, Donadio MV. Rhinopharyngeal Retrograde Clearance Induces Less Respiratory Effort and Fewer Adverse Effects in Comparison With Nasopharyngeal Aspiration in Infants With Acute Viral Bronchiolitis. Respir Care. 2016 Dec;61(12):1613-1619. doi: 10.4187/respcare.04685. Epub 2016 Aug 23.

    PubMed 27555618

Questions about this trial

What is this clinical trial studying?

A study testing Rhinopharyngeal clearance, Aspiration and 0.9% saline in people with Acute Viral Bronchiolitis, run by Pontificia Universidade Católica do Rio Grande do Sul.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of chest retractions as a measure of respiratory distress (time frame: 30 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02460614, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in