Chest Physiotherapy in Infants Between 0 and 12 Months Old With Acute Bronchiolitis SRV(+)

NCT02853838 | Completed

• 1 other identifier: 2014-84
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to determine the effect of prolonged slow expiration techniques, provoked coughing and standard therapy compared to chest wall manual vibration and standard therapy in infants between 0 and 12 months old with confirmed diagnosis of acute bronchiolitis SRV (+). The effect will be measured on respiratory insufficiency and use of supplementary oxygen.

Conditions

Bronchiolitis, Viral

Keywords

acute viral bronchiolitis; respiratory syncytial virus; chest physiotherapy

Outcome Measures

Primary Outcomes (1)

• Clinical score of respiratory distress

  Wang clinical severity score

  48 hours after baseline measurement

Secondary Outcomes (7)

• Hours of supplementary oxygen

  48 hours after baseline measurement

• Peripheral blood oxygen level

  Baseline, 30 min, 60 min, 120 min,12 hours, 24 hours, 36 hours, and 48 hours.

• Heart rate

  Baseline, 30 min, 60 min, 120 min,12 hours, 24 hours, 36 hours, and 48 hours.

• Respiratory rate

  Baseline, 30 min, 60 min, 120 min,12 hours, 24 hours, 36 hours, and 48 hours.

• wheezing

  Baseline, 30 min, 60 min, 120 min,12 hours, 24 hours, 36 hours, and 48 hours.

Other Outcomes (1)

• Transfer to high complexity unit

  96 hours

Study Arms (2)

Prolonged slow expiration+provoked coughing+ST

EXPERIMENTAL

Prolonged slow expiration+provoked coughing+Standard Therapy

Other: Prolonged slow expiration+provoked coughing; Other: Standard Therapy

Manual chest wall vibration+ST

ACTIVE COMPARATOR

Manual chest wall vibration+Standard Therapy

Other: Manual chest wall vibration; Other: Standard Therapy

Interventions

Prolonged slow expiration+provoked coughing OTHER

Five cycles of prolonged slow expiration and provoked coughing, which will be repeated five times. During the prolonged slow expiration, the infant will be in supine while the therapist applies pressure at the same time on the rib cage and abdomen during spontaneous expiration. The pressure is applied slowly during two o three respiratory cycles, only during the final phase of expiration.

Prolonged slow expiration+provoked coughing+ST

Manual chest wall vibration OTHER

Five cycles of manual chest wall vibrations during 20 seconds each, being repeated five times. The manual chest wall vibrations are oscillatory maneuvers applied on the thorax to improve mucociliary clearance of bronchial mucus and ease its removal.

Manual chest wall vibration+ST

Standard Therapy OTHER

Standard therapy (ST): nasopharyngeal suction, oxygen therapy, fluids administration, 0.5% adrenaline nebulization, and chest physiotherapy.

Manual chest wall vibration+ST; Prolonged slow expiration+provoked coughing+ST

Eligibility Criteria

• Age: 15 Days - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Clinical diagnosis of bronchiolitis.
• RSV positive in direct immunofluorescence assay.
• Wang clinical severity score ≥ 4 points.

You may not qualify if:

• Patients with heart or neurological diseases.
• Previous episodes of wheezing.
• Chronic conditions such as bronchopulmonary dysplasia, immunodeficiency, or congenital diseases.
• Need of mechanical ventilation in Intensive Care Unit
• Contraindication criteria for chest physiotherapy (i.e. Pneumothorax, ribs fractures, hemodynamic instability).
• Patients not receiving supplementary oxygen.

Sponsors & Collaborators

• Universidad del Desarrollo: lead
• Hospital Padre Hurtado: collaborator

Study Sites (1)

Hospital Padre Hurtado

Santiago, Santiago Metropolitan, Chile

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, Viral

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Patricio Gomolán

  Universidad del Desarrollo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: July 22, 2016
• First Posted: August 3, 2016
• Study Start: March 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 26, 2016

Record last verified: 2016-10

Locations

CL (1)