Mucociliary Clearance Techniques in Moderate Bronchiolitis

NCT04553822 | Completed DMC

• 1 other identifier: 9.0
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

Brief Summary

Acute viral bronchiolitis (BE) is an inflammatory disease of the lower respiratory tract, with a viral etiology, where the respiratory syncytial virus is the most prevalent agent. Respiratory physiotherapy (FTR) aims to remove airway obstruction, which decreases airway resistance, improves gas exchange, and reduces respiratory load. It is widely used in the treatment of children with chronic respiratory disease, but has long been debated as a treatment for bronchiolitis. The objective of this study is to evaluate the effectiveness of two mucociliary clearance techniques in non-hospitalized children \<12 months with a first episode of moderate BE. This is a clinical trial that aims to recruit patients from 2 to 12 months who attend the Physiobronchial physiotherapy centers in Madrid, A Coruña, and Barcelona with a first-time medical diagnosis of BQ of 48 hours of maximum evolution. Participants will be randomly assigned into 3 groups: Group A: Assisted Autogenous Drainage (DAA), Group B: Prolonged Slow Expiration (ELPr) and Control Group. The main variables are the Acute Bronchiolitis Severity Scale (ESBA), oxygen saturation (SaO2), the modified Wood-Downes scale (WD-S), the Hospital scale Sant Joan de Déu (HSJD) and the ReSVinet Scale (RSV-S), and will be measured by a blinded evaluator at the beginning of the session (T0), 20 minutes after administering short-acting β2 adrenergic agonist (SABA) (T20 ), immediately after nebulization (T40) and at the end of the physiotherapist's intervention (T60). It will be reassessed 48 hours after the session (T48h) and the protocol will be repeated completely if it has not dropped at least two points according to the scales.

Conditions

Bronchiolitis

Keywords

Physical Therapy; Respiratory; Pediatric

Outcome Measures

Primary Outcomes (1)

• Acute Bronchiolitis Severity Scale

  Is a quantitative cumulative scale designed to assess clinical severity in patients with BE. The clinical severity scoring system is made up of five items: wheezing or crackles (only the one with the highest score is taken into account), effort, i / e ratio, RR and HR. Each item is scored from 0 to 4, the values of each item are added and a total result of (0-4) mild, (5-9) moderate and (10-13) severe is obtained, with 13 being the maximum score and 0 the minimum.

  48 hours

Secondary Outcomes (2)

• Wood-Downes Scale modified by Ferres (WDF-S)

  48 hours

• Scale of the Sant Joan de Déu Hospital

  48 hours

Study Arms (3)

Assisted autogenous drainage group (DAA)

EXPERIMENTAL

The technique consists of positioning the patient in a supine position with the head slightly elevated on the supporting plane and then placing both hands around the rib cage and applying bimanual expiratory compression on both hemithoraxes.

Other: Assisted autogenous drainage group (DAA)

Group prolonged slow expiration (ELPr)

EXPERIMENTAL

This technique is applied to the baby by means of a slow thoracic-abdominal pressure that begins at the end of a spontaneous expiration and continues until the residual volume.

Other: Group prolonged slow expiration (ELPr)

Control group (CG)

ACTIVE COMPARATOR

Nebulization with 4 ml Muconeb® 3% hypertonic serum, for 8 minutes in a Philips® vibrating mesh nebulizer.

Other: Control group (CG)

Interventions

Assisted autogenous drainage group (DAA) OTHER

DAA, is used when the patient is not able to perform this technique autonomously and is assisted by the physiotherapist. Its greatest utility is in infants and preschoolers. The technique consists of positioning the patient in a supine position with the head slightly elevated on the supporting plane and then placing both hands around the rib cage and applying bimanual expiratory compression on both hemithoraxes. The physiotherapist must ensure that the child takes 2 to 3 controlled breaths, close to the residual level, with the objective that the expiratory flow displaces the secretions, located distally, towards the central airways.

Assisted autogenous drainage group (DAA)

Group prolonged slow expiration (ELPr) OTHER

Passive expiratory aid technique applied to the baby by means of a slow thoracic-abdominal pressure that begins at the end of a spontaneous expiration and continues until the residual volume. The physiotherapist through the provoked cough or stimulation of the trachea achieves the expectoration of the sputum.

Group prolonged slow expiration (ELPr)

Control group (CG) OTHER

Nebulization with 4 ml Muconeb® 3% hypertonic serum, for 8 minutes in a Philips® vibrating mesh nebulizer. Once the nebulization is finished, you will wait 30 minutes in a closed room.

Control group (CG)

Eligibility Criteria

• Age: 2 Months - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Be between 2 and 12 months of age (according to the latest Clinical Practice Guide on BQ of the National Health System available in Spain, it is considered comorbidity to have less than 2 months old)twenty.
• Have a medical diagnosis of a first episode of acute BE.
• Acute BE with a moderate degree of involvement with a score on the Acute Bronchiolitis Severity Scale (ESBA) ≥ 5 and ≤ 9.
• Acute BE with a degree of moderate severity with a modified Wood-Downes Scale (WD-S) score ≥ 4 and ≤ 5.
• Acute BE in a moderate degree of severity with a score according to the Hospital Sant Joan de Déu (HSJD) scale ≥ 6 and ≤ 10.
• Acute BE in a moderate degree of severity with a score on the ReSVinet Scale ( RSV-S) ≥ 7 and ≤ 13.
• Have not previously received respiratory physiotherapy since diagnosis.
• Oxygen saturation (SaO2) ≥ 94%,and j) have the informed consent of the child's legal guardians.

You may not qualify if:

• Acute BE with a score of ≤ 4 or ≥ 10 according to ESBA.
• Acute BE with a score ≤ 3 or ≥ 6 on the WD-S.
• Acute BE with score ≤ 5 or ≥ 11 in HSJD.
• Acute BE with score ≤ 6 or ≥ 14 in RSV-S, f) SaO2 ≤ 93%.
• Associated congenital heart disease, h ) previous hospitalizations for recurrent wheezing or episode of bronchiolitis requiring admission for more than 48 hours.
• Medical diagnosis of recurrent wheezing.
• Failure to follow up at 48 hours.
• No parental consent.
• Premature infants \<32- 35 weeks.
• Bronchopulmonary dysplasia.

Sponsors & Collaborators

• Guadarrama Hospital: lead
• Fisiobronquial Clínicas: collaborator

Study Sites (1)

J.Nicolas Cuenca Zaldivar

Guadarrama, Madrid, 28440, Spain

Location

Related Publications (1)

• 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.

  PMID: 37010196 DERIVED

MeSH Terms

Conditions

Bronchiolitis

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Juan Nicolas Mr Cuenca Zaldívar

  Hospital Guadarrama, servicio de fisioterapia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single (Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Rehabilitation Service Principal Investigator

Model Details: Single-blind randomized controlled trial

Study Record Dates

• First Submitted: September 12, 2020
• First Posted: September 17, 2020
• Study Start: November 1, 2020
• Primary Completion: March 6, 2022
• Study Completion: April 6, 2022
• Last Updated: June 7, 2023

Record last verified: 2023-06

Locations

ES (1)