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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effectiveness of Chest Physiotherapy in Infants Hospitalized With Acute Bronchiolitis SRV (+): a Randomized Controled Trial

Conditions
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Bronchiolitis, Viral

Intervention / Treatment
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* Other: Prolonged slow expiration+provoked coughing
* Other: Manual chest wall vibration
* Other: Standard Therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Days
Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prolonged slow expiration+provoked coughing+ST<br>Prolonged slow expiration+provoked coughing+Standard Therapy | Other: Prolonged slow expiration+provoked coughing<br>* 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.<br>Other: Standard Therapy<br>* Standard therapy (ST): nasopharyngeal suction, oxygen therapy, fluids administration, 0.5% adrenaline nebulization, and chest physiotherapy.<br>|
| Active Comparator: Manual chest wall vibration+ST<br>Manual chest wall vibration+Standard Therapy | Other: Manual chest wall vibration<br>* 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.<br>Other: Standard Therapy<br>* Standard therapy (ST): nasopharyngeal suction, oxygen therapy, fluids administration, 0.5% adrenaline nebulization, and chest physiotherapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical score of respiratory distress | Wang clinical severity score | 48 hours after baseline measurement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hours of supplementary oxygen |  | 48 hours after baseline measurement | 
| Peripheral blood oxygen level | Oxygen level or saturation is measured with a pulse oximeter | 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 | Wang clinical severity score | Baseline, 30 min, 60 min, 120 min,12 hours, 24 hours, 36 hours, and 48 hours. | 
| wheezing | Wang clinical severity score | Baseline, 30 min, 60 min, 120 min,12 hours, 24 hours, 36 hours, and 48 hours. | 
| Rib cage retractions | Wang clinical severity score | Baseline, 30 min, 60 min, 120 min,12 hours, 24 hours, 36 hours, and 48 hours. | 
| General clinical condition | Wang clinical severity score | Baseline, 30 min, 60 min, 120 min,12 hours, 24 hours, 36 hours, and 48 hours. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute viral bronchiolitis, respiratory syncytial virus, chest physiotherapy