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

Universidad del Desarrollo

Status: Completed

Conditions: Bronchiolitis, Viral

Treatments: Other: Manual chest wall vibration; Other: Standard Therapy; Other: Prolonged slow expiration+provoked coughing

Study type: Interventional

Funder types: Other

Identifiers

NCT02853838

2014-84

Details and patient eligibility

About

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.

Full description

Bronchiolitis is the main cause of hospital admission for infants under 1 year old in Chile. Currently, approximately 4800 children are admitted to the hospital during the cold season, affecting the health services' effectiveness. The most frequent causal agent is the Respiratory Syncytial Virus (RSV). To date, there is no specific treatment for this disease and only support measures are recommended.

Chest physiotherapy is a support measure that improves the mucociliary clearance and reduces obstruction of the airways.

A clinical trial on the effect of prolonged slow expiration (PSE), chest wall vibrations, and provoked coughing as treatment for bronchiolitis in infants admitted to the hospital found that the subgroup with RSV required oxygen for 10 hours less than the control group. Gomes and Postiaux (2012) reported a 50% decrease on respiratory distress measured by the Wang score when PSE and suction were compared to traditional chest physiotherapy techniques in patients with bronchiolitis RSV(+).

Currently recommendations in Chile suggest chest physiotherapy for outpatients with bronchiolitis, but the guideline does not refer to the case of inpatients. It is proposed to carry out a randomized controlled trial in infants under one year old. The active group will receive standard therapy, PSE, and provoked coughing, while the control group will receive standard therapy and manual chest wall vibrations. The effectiveness of chest physiotherapy will be measured though a clinical score of respiratory distress, hours using supplementary oxygen, vital signs before and after the intervention in both groups during hospital stay. The main outcome is clinical severity score 48 hours after admission.

Enrollment: 204 patients

Sex: All

Ages: 15 days to 12 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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204 participants in 2 patient groups

Prolonged slow expiration+provoked coughing+ST

Experimental group

Description:

Prolonged slow expiration+provoked coughing+Standard Therapy

Treatment:

Other: Prolonged slow expiration+provoked coughing

Other: Standard Therapy

Manual chest wall vibration+ST

Active Comparator group

Description:

Manual chest wall vibration+Standard Therapy

Treatment:

Other: Manual chest wall vibration

Other: Standard Therapy