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

Not Applicable
Completed
Conditions
Bronchiolitis, Viral
Interventions
Other: Prolonged slow expiration+provoked coughing
Other: Manual chest wall vibration
Other: Standard Therapy
Registration Number
NCT02853838
Lead Sponsor
Universidad del Desarrollo
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.

Detailed 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
204
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Prolonged slow expiration+provoked coughing+STStandard TherapyProlonged slow expiration+provoked coughing+Standard Therapy
Prolonged slow expiration+provoked coughing+STProlonged slow expiration+provoked coughingProlonged slow expiration+provoked coughing+Standard Therapy
Manual chest wall vibration+STManual chest wall vibrationManual chest wall vibration+Standard Therapy
Manual chest wall vibration+STStandard TherapyManual chest wall vibration+Standard Therapy
Primary Outcome Measures
NameTimeMethod
Clinical score of respiratory distress48 hours after baseline measurement

Wang clinical severity score

Secondary Outcome Measures
NameTimeMethod
Peripheral blood oxygen levelBaseline, 30 min, 60 min, 120 min,12 hours, 24 hours, 36 hours, and 48 hours.

Oxygen level or saturation is measured with a pulse oximeter

Hours of supplementary oxygen48 hours after baseline measurement
General clinical conditionBaseline, 30 min, 60 min, 120 min,12 hours, 24 hours, 36 hours, and 48 hours.

Wang clinical severity score

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

Wang clinical severity score

Rib cage retractionsBaseline, 30 min, 60 min, 120 min,12 hours, 24 hours, 36 hours, and 48 hours.

Wang clinical severity score

Heart rateBaseline, 30 min, 60 min, 120 min,12 hours, 24 hours, 36 hours, and 48 hours.
wheezingBaseline, 30 min, 60 min, 120 min,12 hours, 24 hours, 36 hours, and 48 hours.

Wang clinical severity score

Trial Locations

Locations (1)

Hospital Padre Hurtado

🇨🇱

Santiago, Región Metropolitana, Chile

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